Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)
Phase: NA
Conditions: Cardiovascular Diseases, Cognitive Decline
Sponsor: University of Kansas Medical Center

 
KUMC – HRPP- 03/12/2015 
 
Page 1 of 18
 
 
 
University of Kansas Medical Center  
RESEARCH PROTOCOL INVOLVING HUMAN SUBJECTS  
TEMPLATE WITH GUIDANCE 
 
Version date:  2022-12-22 
Principal Investigator: Ashley Shaw 
Study Title: Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3) 
Co- Investigator(s): Jeffrey Burns, Eric Vidoni, Debra Sullivan 
 
I. 
Purpose, Background and Rationale 
A. Aim and Hypotheses  
 
As the older adult population in the United States continues to rapidly grow, Alzheimer’s Disaese (AD) 
poses a major public health crisis, especially among African Americans (AA) who are disproportionally 
burdened by AD. AA are up to 3 times more likely to develop AD compared to non-Hispanic Whites and 
AD is the 4th leading cause of death among AA.1 Emerging evidence suggests that up to half of AD 
cases are a result of modifiable cardiovascular (CV) risk factors related to poor diet such as elevated 
blood pressure (BP), arterial stiffness, obesity, and diabetes, all of which disproportionately affect AA. 
Furthermore, current evidence indicates that CV risk factors represent a precursor to cognitive decline 
among older adults, which contributes to racial/ethnic disparities seen within AD. Given the high 
prevalence of CV risk factors related to AD among AA, prevention strategies may play a critical role in 
reducing AD risk for AAs.  
 
The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and 
its implementation. Secondary goals of this project are to evaluate cardiometabolic risk profile, 
nutritional health status, and cognition in relation to the MIND+SOUL diet intervention. 
 
The overall objective of this proposed study is to pilot test an adapted brain-healthy diet and test 
acceptability, adherence, CV risk profiles related to AD (e.g. blood pressure, cholesterol, body 
composition), nutritional health status, and cognition. 
 
Aim 1: Assess feasibility and acceptability of the adapted brain-healthy diet intervention in a 
single arm pilot trial 
 
To address Aim 1, we will conduct a purposive sampling and recruit participants (n=30) through the KU 
Alzheimer’s Disease Research Center (KU ADRC) AA Clinical Cohort and the community and screen for 
study eligibility. Additionally, participants will be recruited from flyers and announcements at 
distributed by community partners (Black Health Care Coalition and New Bethel Church Community 
Development Corporation). Inclusion criteria for eligible participants include 1) self-identifying as AA or 
Black, 2) aged 55 years and older, 3) English speaking, 4) cognitively normal with an Eight-item 
Interview to Differentiate Aging and Dementia (AD8) < 2, 5) 1 or more cardiovascular risk factors 6) 
females of child-bearing potential (i.e., pre-menopausal) must have a negative urine pregnancy test at 
the screening visit and must agree to use of contraception throughout the trial. The approved methods 
of contraception are abstinence, the consistent use of an approved oral contraceptive (birth control pill 
or “the pill”), an intrauterine device (IUD), hormonal implants, contraceptive injection, double barrier 
method (diaphragm with spermicidal gel or condom with contraceptive foam).Using a small single arm 

 
KUMC – HRPP- 03/12/2015 
 
Page 2 of 18
 
 
 
trial we will test the community-informed culturally tailored diet and education plan that was developed 
in a previous study (IRB #00146894) with a primary goal of evaluating feasibility and acceptability of 
the diet and its implementation. 
 
Aim 2: Explore cognitive functions associated with the brain-healthy soul food diet 
intervention as preliminary data to design a RCT. 
 
To address aim 2, we will assess change in cognition among AA in a single arm trial. Participants will be 
scheduled to complete a cognitive measurement session (approximately 30 minutes) at the KU ADRC at 
the baseline and 12 week mark. The NIH Toolbox will be used to assess cognition using one test in each 
of the following domains: memory, language, reading, vocabulary, processing speed, and executive 
function. 2 Specifically the following tests will be administered: NIH-TB List Sorting Working Memory 
Test, NIH-TB Picture Vocabulary Test, NIH-TB Oral Reading Recognition Test, and the NIH-TB Pattern 
Comparison Processing Speed Test, and NIH-TB Flanker Inhibitory Control and Attention. Between 
group differences will be analyzed using ANOVA. 
 
Primary Outcome 
Feasibility and Acceptability Data Collection:  
Feasibility will be assessed by 1) collecting measures including cardiometabolic risk (e.g. blood pressure 
and blood draw – lipid profile, inflammation), body composition (DXA), dietary assessments (NHANES 
diet screening questionnaire and skin carotenoid assessment), and cognitive assessments (NIH 
toolbox), 2) recruitment throughout the intervention including reasons for refusal to participate and 3) 
retention rates including attrition (80% compliant) rate of completion of the intervention (i.e. 
number/percentage of participants who complete all aspects of the intervention including cooking 
classes and coach directed dietary call support).  
 
Acceptability will be assessed post-intervention using two REDCap online surveys,3 that will capture the 
overall experience and perception of the MIND+SOUL diet. For the first survey acceptability will be 
evaluated on the theoretical framework of acceptability and evaluate the following constructs4: affective 
attitude (how an participant feels about the MIND+SOUL intervention), burden (perceived amount of 
effort required to participate in the MIND+SOUL intervention), ethicality (extent to which the 
intervention has good fit with the participants value system), perceived effectiveness (extent to which 
the intervention is perceived as likely to achieve its purpose), and self-efficacy(participants confidence 
that they can perform the behaviors required to participate in the intervention). The second survey will 
evaluate satisfaction with the MIND+SOUL diet using a visual analog scale.  
 
Secondary Outcomes 
Data from our secondary outcomes will form the basis of estimating power and sample size for a future 
randomized controlled clinical trial. 
 
Baseline descriptive statistics including demographic, psychosocial, dietary and behavioral 
characteristics will be measured. 
 
Cardiometabolic risk: Cardiometabolic risk will be measured by 2 items; blood pressure and blood 
draw. Blood pressure will be measured using the Omron 5 series blood pressure monitor.7 Blood draw 
will be administered to collect measurements of lipid profile, glucose metabolism, inflammation, APOE-

 
KUMC – HRPP- 03/12/2015 
 
Page 3 of 18
 
 
 
ε4 genotyping, and other AD related fluid cardiometabolic biomarkers. All cardiometabolic risk 
assessments will be collected at baseline and at the 12-week mark.  
 
Body Composition:  Body composition will be measured using dual energy x-ray absorptiometry 
(DXA)5,6 , height, weight, and waist circumference. Body composition will be collected at baseline and 
at the 12-week mark. Using DXA we will specifically be focusing on changes in fat tissue from baseline 
to the 12-week mark of the MIND+SOUL intervention.    
 
Nutritional health status: Nutritional health status change will be measured using the NHANES 
dietary screener questionnaire and the skin carotenoid assessment (Veggie Meter).9 Using the dietary 
screener questionnaire, we will specifically be focusing on changes in fruit and vegetable consumptions. 
Using the veggie meter, we will  specifically be focusing on changes in skin carotenoid levels. 
Nutritional health status change will be measured at baseline and at the 12-week mark.  
 
Cognitive function: Cognitive function will be measured using the NIH Toolbox to assess the following 
domains: memory, language, reading, vocabulary, processing speed, and executive function. 2 
Specifically the following tests will be administered: NIH-TB List Sorting Working Memory Test, NIH-TB 
Picture Vocabulary Test, NIH-TB Oral Reading Recognition Test, and the NIH-TB Pattern Comparison 
Processing Speed Test, and NIH-TB Flanker Inhibitory Control and Attention. For cognitive function we 
will be specifically focusing on changes in executive function. Cognitive function assessments be 
conducted at baseline and at the 12-week mark. 
 
B. 
Background and Significance 
 
 
Knowledge regarding dietary prevention of AD is based almost exclusively on studies involving non-
Hispanic Whites resulting in limited generalizability of findings for older adults who belong to 
underrepresented and understudied racial/ethnic groups. 10 Dietary intervention studies that 
demonstrate preliminary or cursory ability to protect against cognitive decline, including among AA, 
have demonstrated low adherence and acceptability due to perceived lack of social support, social 
contexts (i.e. cost of healthy foods, reduced access to healthy and diverse food options due to low 
socioeconomic status), strong cultural influence on food preferences and preparation, and perceived 
less appealing taste of low fat foods.11-13 Previous research has indicated that modifying soul food or 
traditional AA recipes to better meet nutritional guidelines would be more effective than suggesting that 
such foods be eliminated from a healthy diet altogether. 14 For example, culturally adapted diets have 
resulted in AA participants lowering BMI, A1C, reducing body weight and waist circumference.15,16 It is 
important to note that traditional soul food includes healthy dietary components, 17 such as fruits and 
vegetables (e.g. collard greens, sweet potatoes, okra, and blueberries), which are linked to improved 
cardiovascular risk markers and slower cognitive decline. 18,19 Moreover, such dietary interventions 
developed for AA have been guided by community participation.20 These elements are consistent with 
our emerging understanding of what makes up a brain healthy diet. Therefore, a need for a novel 
culturally relevant and adaptable dietary intervention to effectively address barriers to adoption. 
 
 
C. 
Rationale 
 
There is a critical need for the development of a culturally adapted brain healthy diet 
that is congruent with mainstream AA cultural values and preferences. This project 
incorporates the adoption of a community engaged research approach to address critical challenges 
associated with health disparities research in aging among older AA. The project is novel in its approach 
to both design and implementation of the soul food brain healthy diet intervention, which is informed 
by the local AA community’s attitudes, beliefs, values, and cultural dietary practices. Additionally, this 

 
KUMC – HRPP- 03/12/2015 
 
Page 4 of 18
 
 
 
project addresses known challenges often associated with dietary interventions among minorities 
including perception of losing one’s culture, cost, and geographical access.  
 
MIND stands for Mediterranean-DASH Intervention for Neurodegenerative Delay. The MIND diet aims to 
reduce the risk of dementia and the decline in brain health that often occurs as people age. The MIND 
diet is a combination of two well-known eating patterns: the Mediterranean diet and the Dietary 
Approaches to Stop Hypertension (DASH) diet. The Mediterranean diet is inspired by the traditional 
eating habits of people in Mediterranean countries. It emphasizes eating healthy fats such as extra-
virgin olive oil and nuts, fresh fruits and vegetables, and whole grains and legumes while limiting 
consumption of red meat and added sugars. Like the Mediterranean diet, the DASH diet centers around 
fruits, vegetables, whole grains, and lean meats. Because it was developed to treat hypertension, it 
also limits daily sodium intake. What makes the MIND diet unique is that it focuses on the specific 
foods and nutrients that have been shown to boost and protect brain health and reduce the risk of 
Alzheimer's disease and dementia. For example, while the Mediterranean diet includes a general 
recommendation to eat more fruit, the MIND diet specifically recommends eating berries several times 
per week because research has shown a link between eating berries and having better cognitive 
function. Previous research has shown that adherence to the MIND diet reduced risk of AD by 53% 
among participants who rigorously followed the diet and by 35% among participants who followed the 
diet moderately well over 4.5 years. 29  Moreover, adherence to the MIND diet has been found to 
reduce the risk of CVD by up to 65%.30Findings from this proposed study will be significant in 
advancing AD lifestyle prevention knowledge in the field of Alzheimer’s Disease and Related Dementia 
(ADRD) and will provide fundamental new knowledge regarding the impact of a healthy diet has on 
ADRD cardiovascular risk factors and cognition among older AA. Furthermore, findings from the 
proposed study will advance knowledge regarding approaches to deliver a culturally acceptable brain 
healthy diet intervention, framing future ADRD lifestyle prevention.  
 
II. 
Research Plan and Design 
 
A. Study Objectives: 
Aim 1: Assess feasibility and acceptability of the adapted brain-healthy diet intervention in a 
single arm pilot trial. A purposive sample (n=30) aged 55 years and older who self-identify as 
African American or Black will participate in a single arm dietary intervention trial to evaluate feasibility 
and acceptability of the diet and its implementation. 
 
Aim 2: Explore cognitive functions associated with the brain-healthy soul food diet 
intervention as preliminary data to design a RCT. We assess change in cognition among AA in a 
single arm trial. 
 
B. Study Type and Design:  
This is a single arm trial designed to pilot test an adapted brain healthy diet intervention among older 
AA (n=30). Specifically, this study aims to evaluate the feasibility and acceptability of the brain healthy 
soul food diet intervention. As secondary outcomes, this study aims to assess body composition, 
cardiometabolic risk, nutritional health status, and changes in cognition among older AA to form the 
basis of estimating power and sample size for a future full-scale randomized controlled clinical trials.  
 
Study visit summary 
In Year 1, we will conduct purposive sampling and recruit participants (n=30) through the KU ADRC AA 
Clinical Cohort and KU ADRC recruitment database, through partnership with our community partners 
Ms. Briana Bright (CEO of Bright Business Solutions), Ms. Melissa Robinson (Executive Director of Black 
Health Care Coalition), Mr. Harry Evans (CEO of Black Men HEAL) and through the delivery of Aging 
With Grace; a culturally tailored dementia prevention curriculum within the community. Additionally, 
participants will be recruited from flyers distributed by consultants.  
 

 
KUMC – HRPP- 03/12/2015 
 
Page 5 of 18
 
 
 
The study team will phone pre-screen potential participants prior to scheduling an in-person baseline 
evaluation. The phone pre-screen will assess inclusion and exclusion criteria using a brief telephone 
interview guide to screen for dementia using the AD-8 assessment and for depresson using the PHQ9 
assessment, as well as demographics. If it has been more than 60 days (+/- 2 weeks) since the AD-8 
and PHQ9 have been completed and the date of the baseline visit, an additional AD-8 and PHQ9 will be 
done within the prescreening period to ensure there is no more than 60 days between screening with 
AD-8 and PHQ9 and the baseline visit.  Individuals deemed eligible who consent to participate in the 
study will be placed into 1 of the 3 trial cohorts. Cohort 1 will include 10 people, cohort 2 will include 10 
people, and cohort 3 will include 10 people. All participants will be asked to provide informed consent 
before compleing any baseline assessments. Baseline evaluations will include body composition, 
cardiovascular assessments, dietary assessments, and cognitive assessments.   
 
Baseline evaluation: The baseline evaluation will consist of a 1-day visit to the University of Kansas 
Alzheimer’s Disease Research Center (KU ADRC). Participants will typically be consented in person the 
day of the baseline evaluation by study staff.  In certain circumstances, in which the participant needs 
a shortened length of time spent at the clinic for the baseline visit, remote consent may be conducted 
within a few days prior to the baseline visit.  Prior to completion of any baseline procedures, study staff 
will first review the inclusion and exclusion criteria and confirm that the participant meets eligibility.  
 
Participants will then complete the dietary assessments, body composition assessment, cardiometabolic 
risk assessments, and cognitive assessment at the KU ADRC.  
 
The baseline visit will include: 
1. Informed Consent: The participant will be provided with a copy of the consent form at least one 
day prior to the consenting session, either via mail, email, or REDCap.   A member of the study 
team will  review the consent form, in its entirety, with the patient, typically in person at the 
baseline visit. In some instances, a participant may request to conduct the consenting session 
remotely and prior to the baseline visit, to keep the time in clinic to a minimum, or if other 
obligations (such as work commitments) limit their availability.  The study team will answer all 
questions before obtaining the participant’s written or electronic signature (via REDCap) 
indicating their consent. Once the consent form is also signed by the person obtaining consent, 
a copy of the fully signed document is returned to the participant.  If consent was conducted 
remotely, a copy of the  fully signed consent form may be returned to the participant in person 
at the baseline visit, or through email via REDcap. 
2. Medical History: The medical history information that was gathered from the participant during 
the phone pre-screen to determine eligibility will be reviewed and updated if necessary. The 
study team will also record participant’s current medications. 
3. Final Review of Eligiblity: As all eligility criteria were assessed during the phone screen, with the 
exception of Exclusion Criterion (f): uncontrolled blood pressure, blood pressure will be checked 
first (using the Omron 5 series blood pressure monitor7).  In addition, the study team will review 
all other eligibility criteria with the participant to ensure there have been no changes in eligibility 
status since the phone pre-screen. The PI will confirm the participant meets all eligilbity criteria 
before proceeding with the rest of the baseline measures. 
4. Dietary assessments: Nutritional health status change will be measured using the NHANES 
Dietary Screener Questionnaire and the skin carotenoid assessment (Veggie Meter).9 
5. Body composition: Body composition will be measured using dual energy x-ray absorptiometry 
(DXA)5,6, weight, and waist circumference.  
6. Cardiometabolic risk: Blood pressure will be measured immediately following informed consent, 
as described above in #2.  Blood draw will be administred to collect measurements of lipid 
profile, glucose metabolism, inflammation, APOE-ε4 genotyping, and other AD related fluid 
cardiometabolic biomarkers. 
7. Cognitive assessment: NIH Toolbox will be used to assess the following cognitive domains: 
memory, executive function, language, reading, vocabulary, and processing speed.2 

 
KUMC – HRPP- 03/12/2015 
 
Page 6 of 18
 
 
 
 
 
12-week evaluation: All participants will return to complete all in-person evaluations identical to the 
baseline evaluation in addition to completing acceptability surveys.  
 
MIND+SOUL Single Arm 
 
Education:  Participants will receive educational training including ongoing skill building cooking 
classes (see below), sample weekly menu plans (breakfast, lunch, dinner, snacks), recipe cards (simple 
recipes), culturally tailored recipe books/handounts, online cooking resources (i.e. preparation videos), 
grocery shopping guides, faith component (i.e. scripture readings, health devotionals), healthy eating 
culturally tailored devotional books/handounts (i.e. Healthy Eating, God's Way: Weight Loss Devotional 
and Challenge: Calm Your Cravings, Overcome Obsessing, Hone Healthy Habits, and Build Biblical 
Boundaries (Healthy by Design)), affirmations for eating healthy, and a manual that is the basis of the 
MIND+SOUL diet. The manual includes specific MIND+SOUL diet goals (i.e. specific food group goals). 
 
Skill-Building Health Education/Cooking Classes will be held at the KU ADRC. The group classes will be 
held once a week for the first 6-weeks of the MIND+SOUL diet intervention. Behavioral strategies 
shared during the skill-building health education/cooking classes, which are guided by the principles of 
Capability, Opportunity and Motivation Behavioral Change Model, are designed to provide participants 
will knowledge and skills (psychological and physical) to improve dietary consumption and adherence to 
the MIND+SOUL diet.  
 
Counseling: Counseling: Counseling will consist of one-on-one sessions with a health coach who will 
provide MIND+SOUL diet continued education and on-going support throughout the diet intervention. 
This support will consist of education and recommendations specific to the participant’s needs, 
preferences, and local context. The health coach will help participant set dietary goals in relation to the 
MIND+SOUL diet, help participants develop an action plan for certain situations (i.e. holiday parties, 
vacations), and provide encouragement in regards to the formation of healthy eating habits. Zoom 
conference calls will occur bi-weekly for 12-weeks. Each Zoom conference (6 total per participant) is 
anticipated to last 15-20 minutes each time, with exception to the first Zoom conference call which is 
anticipated to up to 30 minutes.  
 
 
Financial support: To improve adherence to the MIND+SOUL diet each participant will receive weekly 
groceries worth up to $50 per week (total average of $600) that will be provided to each participant for 
12-weeks. Groceries will be limited to foods within the 10 distinct food groups of the MIND+SOUL diet. 
These foods will be selected from each week from a community supermarket.  
 
C. Sample size, statistical methods, and power calculation 
 
Single arm: Participants will be in a single arm trial using 3 cohorts (cohort 1 – 10 people, cohort 2 – 
10 people, cohort 3 – 10 people). Rationale: Use of a single arm trial will allow for assessment of 
feasibility and acceptability of the MIND+SOUL diet. Additionally, use of 3 cohort will allow for an 
opportunity to make revisions between each cohort to further enhance feasibility and acceptability of 
the MIND+SOUL diet.  
 
Individuals deemed eligible will be placed into 1 of 3 cohort.  
 
Sample Size: A total of 30 participants will be enrolled in the pilot study. Cohort 1 will consist of 10 
participants, cohort 2 will consist of 10 people, and cohort 3 will consist of 10 people. 

 
KUMC – HRPP- 03/12/2015 
 
Page 7 of 18
 
 
 
 
 
D. Subject Criteria:  
1. Inclusion Criteria 
a. Identify as African American or Black 
b. Age 55 and older  
c. English Speaking  
d. 1 or more of the following CVD risk factors (high blood pressure, high cholesterol, 
controlled type 2 diabetes overweight/obesity with a BMI of 25 or more as calculated 
from weight and height at baseline visit) 
e. Cognitively Normal with an AD8 <2 (normal cognition) 
f. 
Females of child-bearing potential (i.e., pre-menopausal) must have a negative urine 
pregnancy test at the screening visit and must agree to use of contraception 
throughout the trial. The approved methods of contraception are abstinence, the 
consistent use of an approved oral contraceptive (birth control pill or “the pill”), an 
intrauterine device (IUD), hormonal implants, contraceptive injection, double barrier 
method (diaphragm with spermicidal gel or condom with contraceptive foam). 
 
2. Exclusion Criteria 
a. No CVD risk factors 
b. AD8 equal to or greater than 2 
c. Diagnosed with type 1 diabetes 
d. Uncontrolled diabetes type 1 or type 2 
e. Existing diet plan that subject is unable to pause during trial 
f. 
No internet connection 
g. Uncontrolled hypertension, by history, or as indicated by sitting systolic blood 
pressure >165 mmHg or diastolic blood pressure >95 mmHg at the baseline visit. If 
an initial blood pressure reading is higher than this, an additional attempt (at this 
visit or on another day) could be used before excluding a patient for uncontrolled 
hypertension  
h. Neurological diseases that impact cognition 
i. 
Other medical conditions likely to be negatively impacted by a diet change or that 
could confound the study data (i.e. Celiac Disease, Ulcerative Colitis) 
j. 
Unable or unwilling to provide written consent 
k. PI determination that study is unsafe or unsuitable for the participant 
l. 
Active depression as determined by a score of 5 or above on the PHQ9 and deemed 
to be clinically significant by the medical monitor 
3. Withdraw/Termination criteria:   
a. There is no withdraw or termination criteria 
b. Participants are allowed to participate in other observational studies during their 
enrollment period, but not interventional trials 
 
Total enrollment is anticipated to last between 3-4 months total, with 1-1.5 months of 
recruitment per cohort.  
 
E.  Specific methods and techniques used throughout the study  
 
This study will require two study visits. Outcome data will be collected at baseline and at the 12 week 
mark (+/- 2 weeks). The total time commitment for visit 1 is 2.5 hours and visit 2 is 2.5 hours.   
 
Visit 1 – Baseline Evaluation  
 
Estimated duration: 2.5 hours 
 

 
KUMC – HRPP- 03/12/2015 
 
Page 8 of 18
 
 
 
The baseline evaluation will consist of one visit to the KU ADRC to perform the following outcome 
assessments (laboratory test details provided below) within 30 days prior to the start of the diet 
intervention: review of medical history, blood draw, blood pressure, DXA scan for body composition, 
height, weight, waist circumference, NHANES dietary screener questionnaire, skin carotenoid 
assessment, cognitive testing, and survey completion (demographic data). 
 
Informed Consent: The participant will be provided with a copy of the consent form at least one day 
prior to the consenting session, either via mail, email, or REDCap. A member of the study team will  
review the consent form in its entirety with the patient, typically in person at the baseline visit. In some 
instances, a participant may request to conduct the consenting session remotely prior to the baseline 
visit, to keep the time in clinic to a minimum, if other obligations (such as work commitments) limit 
their availability.  The study team will answer all questions before obtaining the participant’s written or 
electronic signature (via REDCap) indicating their consent. Once the consent form is also signed by the 
person obtaining consent, a copy of the fully signed document is returned to the participant.  If consent 
was conducted remotely, a copy of the  fully signed consent form may be returned to the participant in 
person at the baseline visit, or through email via REDcap. 
 
Urine Pregnancy Test:  Female participants who are still of child-bearing potential must undergo a urine 
pregnancy test at the screening visit.  Any participant with a positive pregnancy test will not be eligible 
for the trial. 
 
Medical History (15 minutes): The study team will review and ensure all of the participant’s medical 
conditions and current medications, along with approximate start dates, are recorded. 
 
Blood draw (10 minutes): We will draw ~10cc of blood into an EDTA vacutainer tube at 2 timepoints at 
baseline and 12 weeks (± 2 weeks). Blood will be processed for platelet rich plasma (PRP) and platelet 
free plasma (PFP) and will be stored for analysis. After initial analyses, remaining PRP and PFP will be 
stored in a locked freezer in Dr. Morris’ laboratory (2nd floor Hemenway, badge access area). 
 
Blood pressure (10 minutes): will be measured with an automated sphygmomanometer (DinaMap 
ProCare 100). We will use the NHANES protocol22 and the recommendations of the American Heart 
Association.23  
 
Body Composition (30 minutes): At baseline and 12 weeks (± 2 weeks), dual energy x-ray 
absorptiometry (GE Lunar iDXA) will be used to determine fat-free mass, fat mass, and percent body 
fat. DXA uses very low X-ray doses (0.02mREM) to detect changes in body composition on the order of 
1.6-3.8%. Body weight, height and waist circumference will be recorded at baseline and at the 12 week 
mark (± 2 weeks). Weight will be obtained using a digital scale (+ 0.1 kg; Befour Inc model #PS6600, 
Saukville, WI) and height will be measured using a stadiometer (Model PE-WM-60-84, Perspective 
Enterprises, Portage, MI). Body mass index (kg/m2) will be calculated. Waist circumference will be 
obtained using a calibrated tape.21  
 
Dietary Screener Questionnaire (30 minutes): Nutritional health status change will be measured using 
the NHANES Dietary Screener Questionnaire administered by study personnel. 
 
Skin Carotenoid Content (10 minutes): is a validated, biomarker of fruit and vegetable intake.24-26 The 
“Veggie meter” (Longevity Link Corporation) uses Resonance Raman spectroscopy to non-invasively 
measure skin carotenoid content. Three measurements will be taken on the fingertip and averaged 
(total time ~1 minute) by study personnel. 
 
Cognition (30 minutes): Participants will complete a cognitive measurement session at the KU ADRC at 
the baseline and at the 12-week mark. The NIH Toolbox to assess the following domains: memory, 
language, reading, vocabulary, processing speed, and executive function. 2 Specifically the following 
tests will be administered: NIH-TB List Sorting Working Memory Test, NIH-TB Picture Vocabulary Test, 

 
KUMC – HRPP- 03/12/2015 
 
Page 9 of 18
 
 
 
NIH-TB Oral Reading Recognition Test, and the NIH-TB Pattern Comparison Processing Speed Test, and 
NIH-TB Flanker Inhibitory Control and Attention. Test will be administered by a psychometrician.  
 
Visit 2 – 12-week Evaluation 
 
Estimated duration: 2.5 hours 
 
At 12 weeks (± 2 weeks), participants will return to complete blood draw, blood pressure, DXA scan for 
body composition, height, weight, waist circumference, dietary screener questionnaire, skin carotenoid 
assessment, cognitive testing, a check for adverse events, and survey completion (acceptability 
surveys). 
 
Check for Adverse Events (5 minutes): At the Week 12 Visit, study staff will query the participant for 
any new health conditions that may have arisen since the Baseline Visit.  Adverse event information will 
be collected and recorded as described in section K. Assessment of Subject Safety and Development of 
a Data and Safety Monitoring Plan below. 
 
Acceptability surveys (30 minutes): Participants will complete 2 acceptability surveys at the 12 weeks 
(± 2 weeks). The first survey is a structured survey using 5-point Likert Scale (domains: affective 
attitude (how an participant feels about the MIND+SOUL intervention), burden (perceived amount of 
effort required to participate in the MIND+SOUL intervention), ethicality (extent to which the 
intervention has good fit with the participants value system), perceived effectiveness (extent to which 
the intervention is perceived as likely to achieve its purpose), and self-efficacy (participants confidence 
that they can perform the behaviors required to participate in the intervention). The second survey is a 
satisfaction with MIND+SOUL diet survey using a visual analog scale.  
 
Post Intervention 
 
Focus Group: Upon completion of cohort 1 and cohort 2 a subset of participants will participate in one 
of two focus group discussions to further capture feasibility and acceptability of the MIND+SOUL 
intervention. We will hold two 30-minute virtual semi-structured focus group discussions (n=2-3 
participants per focus group) to capture feasibility and acceptability of MIND+SOUL intervention. Focus 
group participants will receive a $25 Visa gift card for their participation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Visit Schedule 

 
KUMC – HRPP- 03/12/2015 
 
Page 10 of 18
 
 
 
 
 
Baseline Visit 
(-30 Days) 
Week 1-Week 6 
(Day 0) 
Week 7-Week 11 
Week 12 Visit 
(+/- 2 
weeks) 
Informed Consent 
X 
 
 
 
Urine pregnancy test, as 
needed 
X 
 
 
 
Medical History/ Current 
medications 
X 
 
 
 
Blood Pressure 
X 
 
 
X 
Verification of Eligilbity 
X 
 
 
 
DXA Scan 
X 
 
 
X 
Height / Weight/Waist 
circumference 
X 
 
 
X 
Blood Draw 
X 
 
 
X 
NHANES Dietary Screener 
Questionnaire 
X 
 
 
X 
Skin Carotenoid Content 
X 
 
 
X 
NIH Toolbox Cognitive Battery 
X 
 
 
X 
Acceptability Surveys 
(structured survey and Visual 
Analog Scale) 
 
 
 
X 
Adverse Event Check 
 
 
 
X 
Skill Building Health 
Education/Cooking Classes 1x 
week 
 
x 
 
 
Health Coaching 2x Month 
 
x 
x 
 
 
Testing Results 
The participant may be given a copy of their results related to their blood pressure, blood draw results, 
and body composition if they request it. The data will not be reviewed by the research team or a 
physician for the presence of clinically relevant abnormalities.  
 
F. Risk/benefit assessment:   
1. Physical risk  
a. Blood draw: Participants May feel soreness, swelling, and bruising at the puncture 
site during the blood draw. This should go away within a day. Good clinical 
practice guidelines will be followed for biospecimen sampling. 
b. DXA: There is always a slight chance of cancer from excessive exposure to 
radiation. However, given the small amount of radiation used in medical imaging, 
the benefit of an accurate diagnosis far outweighs the associated risk. 
c. Food consumption: There is a chance that participants may experience 
gastrointestinal symptoms when consuming foods on the MIND+SOUL diet 
including but not limited to: nausea, vomiting, diarrhea, acid reflux, heartburn, 
indigestion, bloating/excess gas, hiccups, halitosis, cramping, abdominal pain, 
irritable bowel syndrome, constipation, change in bowel movements, and 
hemorrhoids, gallstones.  
2. Psychological risk. There is minimal risk for psychological distress due to the nature of 
the research topic.  
3. Social risk. There is minimal risk due to the nature of the research topic. 
4. Economic risk. There is minimal risk due to the nature of the research topic. Participants 

 
KUMC – HRPP- 03/12/2015 
 
Page 11 of 18
 
 
 
will receive up to $50 worth of groceries each week ($600 total) for 12 weeks during the 
study to offset the cost of healthy foods. Focus group participants will receive a $25 Visa 
gift card for their participation.  
5. Potential benefit of participating in the study  
a. Individuals participating in this study may feel empowered and valued as part of 
Alzheimer's prevention in the African American community  
b. To the field of Alzheimer’s prevention, community participation of this study will 
help guide future research in the development of culturally appropriate dietary 
intervention strategies aimed to reduce the risk of cognitive decline specifically for 
African Americans  
 
G. Location where study will be performed:                                                                     
Laboratory tests, educational sessions, and skill-building health education/cooking classes, will take 
place at the KU ADRC.  Counseling sessions will take place via Zoom. 
 
H. Collaboration (with another institution, if applicable):                                                     
There are no collaboration efforts with another institution.    
I. Community-Based Participatory Research 
 
The KU ADRC has been successful in building community partnerships to bring awareness and enhance 
diversity in clinical trials. The KU ADRC has built partnerships with the Black Health Care Coalition 
(BHCC) and New Bethel Church Community Development Corporation (NBCCDC) to identify community 
centers and churches for recruitment in clinical trials aimed to improve health among AAs. Our partners 
have served as advisers, providing input about the study design, measures, and educational materials. 
For this study, we are partnering with the BHCC and NBCCDC to support recruitment efforts into the 
study.   
 
Heal Black Men, Black Health Care Coalition, and New Bethel Church Community Development 
Corporation will all serve as community engagement and outreach consultants and will provide 
recruitment support into the MIND+SOUL intervention and will help interpret the focus group findings 
to further inform the MIND+SOUL intervention.   
 
Recruitment methods for this study are being adapted to address community needs through 
collaboration with experts in community based participatory research and with those who identify as 
community champions. They offer multiple perspectives necessary to ensure proper communication is 
being delivered with regards to community recruitment and though established relationships in the 
community we can develop greater capacity and success in research participant recruitment. Cultural 
and community attitudes will help provide insight from the perspective of this underserved population 
by gaining a better understanding of their experiences, attitudes, and perspectives for what a brain 
healthy diet should include and how it should be delivered from the community’s standpoint.  
 
The research question came from the team who identified that there is limited research that addresses 
dietary health disparities for ADRD risk reduction among AAs. Further, the KU ADRC, “Aging With 
Grace” curriculum; designed to provide culturally-specific dementia prevention education to the AA 
community has sparked interest along with interest in lifestyle related trials. There are no cultural risks 
for the community anticipated in the study. The PI identifies as AA and has had previous experience 
working with the community to deliver ADRD prevention information and conducting clinical research. 

 
KUMC – HRPP- 03/12/2015 
 
Page 12 of 18
 
 
 
Research results will be shared with the community through a powerpoint or poster presentation at a 
conference and via a letter with a summary of study findings, which will be mailed to participants at the 
end of the study. Further, study findings will be posted on social media outlets such as Facebook and 
Twitter. To sustain a research relationship with the AA community we plan to continue to pursue 
collaborative projects aimed specifically towards focusing on the needs for the community. Upon 
completion of this project we plan to expand this project on a larger scale by designing an AA culturally 
MIND+SOUL diet intervention for implementation as a future R01 scale clinical trial.   
 
K. Assessment of Subject Safety and Development of a Data and Safety Monitoring Plan 
 
1. Elements of the plan include: 
a. Persons/groups who will review the data (study team; independent safety 
monitor): PI: Ashley Shaw, PhD, Medical Monitor: Ryan Townley, MD, and independent 
safety monitor 
b. Plan for safety monitoring and review:  
 
Adverse Event Definitions and Collection 
In this trial, an adverse event (AE) is defined as any untoward or unfavorable medical 
occurrence in a human subject participant, including any abnormal sign, symptom, or disease, 
temporally associated with the participant’s involvement in the research, whether or not 
considered related to participation in the research. 
 
A serious adverse event (SAE) is defined as any adverse event that results in: 
• 
Death 
• 
Life-threatening even, a condition that places the study participant at immediate risk of 
death if they do not seek medical treatment 
• 
Inpatient hospitalization, or prolongation of existing hospitalization 
• 
Permanent disability, defined as the interruption of a study participant’s ability to conduct 
normal life functions 
AE’s will be collected from the time of consent until the final study visit and will be recorded on 
an Adverse Event Report Form.  At each study visit, study staff will query the participant for any 
new AE’s that may have occurred since the last study visit and will check on the status of any 
AE’s that have not previously resolved.   
 
Adverse Event Assessment 
A qualified study clinician will assess all AE’s for severity, causality, and expectedness. This 
assessment will be documented with the medical monitor’s signature and date.  
 
The PI will review all AE assessments and will follow up to obtain any further information 
necessary prior to approving the report.  PI approval of the AE report will be indicated with her 
signature and date.  
 
Severity will be assessed using the following guidelines: 
• 
Mild-The adverse event may or may not be noticeable to the participant and does not 
significantly impact the participant’s ability to complete activities of daily living (ADL’s). 
• 
Moderate- The adverse event is noticeable and causes some inconvenience and impact 
on the ability to complete ADL’s. 
• 
Severe-The adverse event has a very significant impact on the participant’s ability to 
complete ADL’s. 
Causality, or relatedness to study intervention or procedures, will be categorized as: 

 
KUMC – HRPP- 03/12/2015 
 
Page 13 of 18
 
 
 
• 
Definitely Related: The adverse event is clearly related to the study intervention / 
procedure – i.e., an event that follows a reasonable temporal sequence from 
administration of the study intervention, follows a known or expected response pattern to 
the suspected intervention, that is confirmed by improvement on stopping and 
reappearance of the event on repeated exposure and that could not be reasonably 
explained by the known characteristics of the subject’s clinical state.  
• 
Probably Related: The adverse event is more likely than not attributable to study 
intervention or procedures. i.e While other causes of the event may be possible, the 
temporal relationship of the event to the study intervention or procedure and other 
factors lead to the conclusion that the most likely cause is the study 
intervention/procedure. 
• 
Possibly Related: An adverse event that follows a reasonable temporal sequence from 
administration of the study intervention and follows a known or expected response 
pattern to the suspected intervention, but that could readily have been produced by a 
number of other factors.  
• 
Not Related: The adverse event is clearly not related to the study intervention /procedure 
- i.e., another cause of the event is most plausible; and/or a clinically plausible temporal 
sequence is inconsistent with the onset of the event and the study intervention and/or a 
causal relationship is considered biologically implausible.  
Expectedness refers to the whether the AE is anticipated based on current knowledge of the 
nature, severity, and frequency of the risks of the study intervention, as defined in the protocol 
and in the informed consent form.  Thus, an event may be listed as a known potential risk, but if 
the event occurs in a more severe intensity or occurs more frequently than what is known, the 
event would be considered unexpected. 
 
Adverse Event Reporting 
 
The PI will ensure that all AE’s that meet reportability criteria will be reported to the IRB within 
the expedited IRB-specified timeframe. The KU IRB requires reporting of AE’s (whether serious 
or non-serious) that are determined to be related or probably related to study participation and 
that were unexpected.  The timeframe for reporting AE’s/ SAE’s that meet these criteria is within 
five working days of the PI learning of the event.  An exception to this timeframe is the 
reporting of deaths that are determined to be related or probably related to study participation.  
These must be reported within 24 hours by phone or email, with a full adverse event report 
submitted within five working days. 
 
Any SAE that is related or probably related to study participation and that is unexpected will also 
be reported expeditiously to the NIA program officer and to the independent safety officer, 
within 48 hours of knowledge of the SAE.  However, SAE’s that result in death that are 
determined to be related to the study will be reported to the NIA program officer within 24 
hours of learning of the event. 
 
A summary of all AE’s/ SAE’s will be reported to the NIA program officer on a quarterly basis. 
The PI and medical monitor will also review all AE’s/ SAE’s on quarterly basis as described below 
in the Data and Safety Monitoring Plan. 
Data and Safety Monitoring Plan 
The data and safety monitoring plan consists of oversight by an independent safety monitor.   
 
At the conclusion of each cohort of the study intervention, the study team will provide a report 
to the independent safety monitor detailing all AE’s that have occurred to date.  Following the 
review of safety data, the safety monitorr will document his assessment of safety and his 
determination to: 1) continue the study without any modifications, 2) continue the study, but 

 
KUMC – HRPP- 03/12/2015 
 
Page 14 of 18
 
 
 
only with additional monitoring or other specified modifications to the protocol or 3) discontinue 
the study due to safety issues. 
 
 
III. 
Subject Participation 
 
A. Recruitment: The PI and the Outreach and Recruitment Core at the KU ADRC will contact 
potential participants through the Clinical Cohort registry via recruitment letter, email, and 
phone. Secondly, Dr. Shaw and support personnel will recruit through the delivery of Aging 
With Grace educational curriculum to faith-based and AA serving organizations and will 
distribute flyers during each presentation. Lastly, Dr. Shaw’s community partners (Bright 
Business Solutions, BHCC, and Heal Black Men) and consultants will each help recruit AAs 
through their personal connections and resources. BHCC, Bright Business Solutions, Health 
Black Men, and consultants will be provided with flyers about the study to provide to their 
personal connections. Community members who are interested in participating in the study 
will reach out to the PI or support personnel via email or phone.  
B. Screening Interview/questionnaire: The PI or support personnel will provide details 
regarding the nature of the study, and will conduct an interview to screen for eligibility for 
the study, following verbal consent from the participant to proceed with the screening 
questions.  This interview will include a review of medical conditions, the completion of the 
AD8 measure to screen for cognitive impairment, the completion of the PHQ9 measure to 
screen for active depression, and a review of all eligibility criteria that can be completed prior 
to baseline to determine eligibility.  One eligibility criterion that cannot be completed prior to 
baseline is Exclusion (f): Uncontrolled hypertension, by history, or as indicated by 
sittingsystolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg at the 
baseline visit. If an initial blood pressure reading is higher than this, an additional attempt 
(at this visit or on another day) could be used before excluding a patient for uncontrolled 
hypertension.  Individuals deemed eligible via the phone screen will be placed into 1 of 3 
cohorts, provided the participant does not meet exclusion criterion (f) at the baseline visit. 
C. Alternatives to Participation: none 
D. Costs to Subjects: There is no cost to subjects for participation in this study.  
E. How new information will be conveyed to the study subject and how it will be 
documented: No information regarding cardiometabolic health, nutritional status, or 
cognition will be conveyed to the participant. 
F. Payment, including a prorated plan for payment: Each participant will receive groceries 
worth up to $50 per week (average total of $600) that will be provided weekly for 12 weeks. 
Groceries will be limited to foods within the 10 distinct food groups of the MIND+SOUL diet. 
These foods will be selected each week from a community supermarket and ordered by the 
research team. Focus group participants will receive a $25 Visa gift card for their 
participation.    
G. Payment for a research-related injury: The likelihood for research-related injury is 
extremely low and there will be no  payment to the study participant for such injury. We will 
include the following text in the consent form: “If you have a physical injury as a result of 
participating in this study, treatment will be provided for you at the usual charge.  Treatment 

 
KUMC – HRPP- 03/12/2015 
 
Page 15 of 18
 
 
 
may include first aid, emergency care and follow-up care, as needed.  Claims will be 
submitted to your health insurance policy, your government program, or other third party.  
You will be billed for the costs that are not covered by the insurance. You do not give up any 
legal rights by signing this form.” 
IV. 
Data Collection and Protection 
A. Data Management and Security: Information from these tests will be entered into a 
research database. The PI and SC will supervise the data acquisition. Data will be coded for 
confidentiality and only the PI, study team, and statistician will have access to the code. 
Hard copies of study files are kept in a dedicated, locked cabinet in a badge-access area. 
Subject data will be coded prior to sending it to the statistician for statistical analyses.   
 
B. Sample / Specimen Collection: N/A 
C. Tissue Banking Considerations: N/A 
D. Procedures to protect subject confidentiality: Much of the study data will be direct 
entered (entered as it is collected and not first recorded on paper forms) onto custom 
developed electronic source document forms created in Research Electronic Data Capture 
(REDCap). Exceptions to this direct entry method include the cognitive testing scores, which 
will be retrieved from the NIH Toolkit portal. Other measures may be recorded on paper 
forms in the event access to the REDcap database is disrupted for any reason.  
REDCap is a secure, web-based application designed to support data capture for research 
studies, providing: 1) an intuitive interface for validated data entry; 2) audit trails for 
tracking data manipulation and export procedures; 3) automated export procedures for 
seamless data downloads to common statistical packages; and 4) procedures for importing 
data from external sources. REDCap on the KUMC campus sits on a HIPAA compliant, 
password protected server. The KU ADRC has extensive experience building and maintaining 
REDCap databases, including those used for the preliminary data in this application. 
Confidentiality is strictly safeguarded by HIPAA-compliant standards.  
E. Quality Assurance / Monitoring: The study team will perform  source data verification 
and self-assessment of records at the completion of each cohort of the intervention to 
ensure that data are accurate. 
 
V. 
Data Analysis and Reporting 
A. Statistical and Data Analysis:  Information from these tests will be entered into a 
research database. The PI, SC, and study team will supervise the data acquisition. Data will 
be coded for confidentiality and only the PI, SC, study team and statistician will have access 
to the code. Hard copies of study files are kept in a dedicated, locked cabinet in a badge-
access area. Subject data will be coded prior to sending it to the statistician for statistical 
analyses.  
 
Using an ANOVA model, 10 samples per time point (total 3 time points) will achieve 80% of 
power to detect a maximum change of the standardized measurement (raw measurement 
divided by its standard deviation) across the 3 time points with a magnitude 1.3 (A 

 
KUMC – HRPP- 03/12/2015 
 
Page 16 of 18
 
 
 
magnitude <1 will mean the change is less than the noise level. I would consider a 
magnitude of 1.3 a subtle or a medium sized change.). 
 
Focus group data will be analyzed using the constant comparative coding analysis.27 
Specifically, we will assess if the emerged themes were consistent across the two groups. 
The analysis will occur in three stages.28 During the first stage of open coding, data will be 
placed into small units and will be coded for each unit. Axial coding will occur during the 
second stage in which the codes will be grouped into categories. Selective coding will occur 
during the third stage in which the PI will construct themes that express the content of each 
of the identified grouped categories. 
 
B. Outcome: We expect to determine feasibility and acceptability of the MIND+SOUL diet. 
Feasibility will be assessed by 1) collecting measures including body composition (DXA), 
cardiometabolic risk factor assessments (blood pressure and blood draw), dietary 
assessments (NHANES dietary screener questionnaire and skin carotenoid assessment), and 
cognitive assessments (NIH toolbox), 2) recruitment throughout the intervention including 
reasons for refusal to participate and 3) retention rates including attrition (80% compliant) 
rate of completion of the intervention (i.e. number/percentage of participants who complete 
all aspects of the intervention including cooking classes and coach directed dietary call 
support). Acceptability will be assessed post-intervention using two REDCap online surveys, 
(see attachments) that will capture the overall experience and perception of the MIND+SOUL 
diet. For the first survey, acceptability will be evaluated on the theoretical framework of 
acceptability and evaluate the following constructs: affective attitude (how an participant 
feels about the MIND+SOUL intervention), burden (perceived amount of effort required to 
participate in the MIND+SOUL intervention), ethicality (extent to which the intervention has 
good fit with the participants value system), perceived effectiveness (extent to which the 
intervention is perceived as likely to achieve its purpose), and self-efficacy(participants 
confidence that they can perform the behaviors required to participate in the intervention). 
The second survey will evaluate satisfaction with the MIND+SOUL diet using a visual analog 
scale.  
C. Study results to participants: A letter will be mailed to study participants at the end of 
the study to provide information on the general results of the study.  
D. Publication Plan: Publication of the results of this study will be governed by the policies 
and procedures developed by the study team.   
APPENDIX I: VULNERABLE POPULATIONS 
 
I.    The study does not include vulnerable populations  
 
II.     Cognitively or decisionally impaired individuals: N/A 
 
III.     Children: N/A 
 
IV.     Pregnant women: N/A 
 
V.     Prisoners: N/A 
 

 
KUMC – HRPP- 03/12/2015 
 
Page 17 of 18
 
 
 
VI.     Students and/or Employees: N/A 
 
 
V. 
References 
- 
1. 
Association As. 2019 Alzheimer's Disease Facts and Figures. Alzheimers Dement. 
2019;15(3):321-97.  
- 
2. 
Weintraub S, Dikmen SS, Heaton RK, et al. Cognition assessment using the NIH Toolbox. 
Neurology. 2013;80(11 Suppl 3):S54-S64. doi:10.1212/WNL.0b013e3182872ded 
- 
3. 
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. A metadata-driven 
methodology and workflow process for providing translational research informatics support. J Biomed 
Inform. 2009;42(2):377-81.  
- 
4. 
Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an 
overview of reviews and development of a theoretical framework. BMC Health Services Research. 
2017/01/26 2017;17(1):88. doi:10.1186/s12913-017-2031-8 
- 
5. 
Laskey MA. Dual-energy X-ray absorptiometry and body composition. Nutrition. Jan 
1996;12(1):45-51. doi:10.1016/0899-9007(95)00017-8 
- 
6. 
Shepherd JA, Ng BK, Sommer MJ, Heymsfield SB. Body composition by DXA. Bone. 
2017;104:101-105. doi:10.1016/j.bone.2017.06.010 
- 
7. 
Healthcare O. 5 Series® Upper Arm Blood Pressure Monitor. 
https://omronhealthcare.com/products/5-series-upper-arm-blood-pressure-monitor-bp7200/ 
- 
8. 
Diagnostics P. CardioChek Plus Analyzer. https://ptsdiagnostics.com/cardiochek-plus-
analyzer/ 
- 
9. 
Ermakov IV, Whigham LD, Redelfs AH, et al. Skin Carotenoids as Biomarker for 
Vegetable and Fruit Intake: Validation of the Reflection-Spectroscopy Based “Veggie Meter”. The FASEB 
Journal. 2016;30(1_supplement):409.3-409.3. doi:10.1096/fasebj.30.1_supplement.409.3 
- 
10. 
Morris MC, Tangney CC, Wang Y, et al. MIND diet slows cognitive decline with aging. 
Alzheimer's & dementia : the journal of the Alzheimer's Association. 2015;11(9):1015-1022. 
doi:10.1016/j.jalz.2015.04.011 
- 
11. 
Epstein DE, Sherwood A, Smith PJ, et al. Determinants and consequences of adherence 
to the dietary approaches to stop hypertension diet in African-American and white adults with high 
blood pressure: results from the ENCORE trial. J Acad Nutr Diet. 2012;112(11):1763-1773. 
doi:10.1016/j.jand.2012.07.007 
- 
12. 
Airhihenbuwa CO, Kumanyika S, Agurs TD, Lowe A, Saunders D, Morssink CB. Cultural 
aspects of African American eating patterns. Ethnicity & Health. 1996;1(3):245-260.  
- 
13. 
Tangney CC, Kwasny MJ, Li H, Wilson RS, Evans DA, Morris MC. Adherence to a 
Mediterranean-type dietary pattern and cognitive decline in a community population–. The American 
journal of clinical nutrition. 2011;93(3):601-607.  
- 
14. 
Rankins J, Wortham J, Brown LL. Modifying Soul Food for the Dietary Approaches to Stop 
Hypertension Diet(dash) Plan: Implications for Metabolic Syndrome(dash of Soul). Ethnicity & disease. 
2007;17(3):7-12.  
- 
15. 
Ard JD, Cox TL, Zunker C, Wingo BC, Jefferson WK, Brakhage C. A study of a culturally 
enhanced EatRight dietary intervention in a predominately African American workplace. J Public Health 
Manag Pract. Nov-Dec 2010;16(6):E1-E8. doi:10.1097/PHH.0b013e3181ce5538 
- 
16. 
Anderson-Loftin W. Soul Food Light: A Clinical Trial of a Culturally Competent Dietary 
Self-Management Intervention for Rural African-Americans With Diabetes. 2004: 
- 
17. 
Jefferson WK, Zunker C, Feucht JC, et al. Use of the Nominal Group Technique (NGT) to 
understand the perceptions of the healthiness of foods associated with African Americans. Evaluation 
and program planning. 2010;33(4):343-348.  
- 
18. 
Morris MC, Wang Y, Barnes LL, Bennett DA, Dawson-Hughes B, Booth SL. Nutrients and 
bioactives in green leafy vegetables and cognitive decline: Prospective study. Neurology. 
2018;90(3):e214-e222. doi:10.1212/WNL.0000000000004815 
- 
19. 
Nilsson A, Salo I, Plaza M, Björck I. Effects of a mixed berry beverage on cognitive 
functions and cardiometabolic risk markers; A randomized cross-over study in healthy older adults. 
PLoS One. 2017;12(11):e0188173-e0188173. doi:10.1371/journal.pone.0188173 

 
KUMC – HRPP- 03/12/2015 
 
Page 18 of 18
 
 
 
- 
20. 
Williams JH, Auslander WF, de Groot M, Robinson AD, Houston C, Haire-Joshu D. Cultural 
relevancy of a diabetes prevention nutrition program for African American women. Health promotion 
practice. 2006;7(1):56-67.  
- 
21. 
Lohman TG, Roche, A.F., and Martorell, R. . Anthropometric Standardization Reference 
Manual. Human Kinetics Books  1988. 
- 
22. 
Centers for Disease Control and Prevention. National Health and Nutrition Survey 
(NHANES): Health Tech/Blood Pressure Procedures Manual. Atlanta, GA: Center for Disease Control and 
Prevention; 2009. 
- 
23. 
Pickering TG, Hall JE, Appel LJ, et al. Recommendations for blood pressure measurement 
in humans and experimental animals: Part 1: blood pressure measurement in humans: a statement for 
professionals from the Subcommittee of Professional and Public Education of the American Heart 
Association Council on High Blood Pressure Research. Hypertension. Jan 2005;45(1):142-61.  
- 
24. 
Ermakov IV, Gellermann W. Validation model for Raman based skin carotenoid detection. 
Arch Biochem Biophys. Dec 01 2010;504(1):40-9. doi:10.1016/j.abb.2010.07.023 
- 
25. 
Jahns L, Johnson LK, Mayne ST, et al. Skin and plasma carotenoid response to a provided 
intervention diet high in vegetables and fruit: uptake and depletion kinetics. Am J Clin Nutr. Sep 
2014;100(3):930-7. doi:10.3945/ajcn.114.086900 
- 
26. 
Mayne ST, Cartmel B, Scarmo S, et al. Noninvasive assessment of dermal carotenoids as 
a biomarker of fruit and vegetable intake. Am J Clin Nutr. Oct 2010;92(4):794-800. 
doi:10.3945/ajcn.2010.29707 
- 
27. 
Leech NL, Onwuegbuzie AJ. Qualitative data analysis: A compendium of techniques and a 
framework for selection for school psychology research and beyond. School Psychology Quarterly. 
2008;23(4):587.  
- 
28. 
Strauss A, Corbin J. Basics of qualitative research techniques. Sage publications 
Thousand Oaks, CA; 1998. 
- 
29. 
Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet 
associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. Sep 
2015;11(9):1007-14. doi:10.1016/j.jalz.2014.11.009 
- 
30. 
Golzarand M, Mirmiran P, Azizi F. Adherence to the MIND diet and the risk of 
cardiovascular disease in adults: a cohort study. Food Funct. Feb 7 2022;13(3):1651-1658. 
doi:10.1039/d1fo02069b 
- 
 
-