Acute Berry Intake on Metabolic Control and Cognitive Function

Study Overview
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Brief Summary
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The objectives of this study are: Evaluate the effects of acute dietary raspberry intake on metabolic-associated impairments in cognitive and psychomotor function in overweight/obese adults (55-70y) following a meal challenge Evaluate the effects of acute dietary raspberry on measures of vascular function.

Detailed Description
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The proposed study will be conducted in humans according to Good Clinical Practice (GCP) guidelines. All subjects will review and sign an Informed Consent Form approved by the Illinois Institute of Technology's Institutional Review Boards (IRB) prior to screening. This multi-center clinical trial is a randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm to evaluate the effects of acute dietary red raspberry intake on cognitive function, inflammation, insulin sensitivity / glucose handling and vascular function in overweight/obese older adults after consuming a standardized challenge meal. A planned sample size of 30 will be enrolled into the study. This study will require one initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per subject to complete. The initial screening visit will provide subject with their site-specific, IRB-approved informed consent document prior to the start of any study related procedures. Subject eligibility will be determined through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, mood and exercise habits. Eligible subjects will follow a limited polyphenolic diet throughout the duration of their participation, although stricter guidelines will be imposed during the 3 days prior to a study visit. Shopping lists and meal plans will be provided to subjects, along with counseling by the investigator's study dietitians, to help subjects adhere to the limited polyphenolic diet. The trial will initiate with a 3-day food diary to assess background (pre-study) dietary intake followed by counseling to follow a diet relatively low in (poly)phenolic rich-beverages/foods, which will be maintained for the duration of the experiment. After an initial 7 day run-in period on the limited polyphenolic diet, subjects will be randomized to 1 of 2 treatment sequences. Treatment codes will be maintained by the principal investigator/study physician. All subjects will receive both treatments, once each on 2 different occasions and separated by at least 1 week. Red raspberries or placebo will be provided with a standardized meal providing 840 kcal. A low-polyphenol snack will be provided to subjects after their final cognitive assessment. Each visit will last   9.5 hours and subjects will be required to remain at the Clinical Unit for the duration of the visit. Blood samples will be collected at 0 (fasting) and at 0.5 h, 1 h, 2 h, 4 h, 5 h, 6 h and 7.5 h via a catheter placed on the non-dominant arm by a registered nurse. Cognitive function will be measured at 0 (fasting), 2 h, and 6 h. FMD or NIRS will be conducted at the CNRC or the HNRCA, respectively at 0 (fasting), and at 1 h and 5 h.

Official Title
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The Effects of Acute Raspberry Intake on the Relationship Between Enhanced Metabolic Control and Cognitive and Psychomotor Function

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Active breakfast
* Dietary Supplement: Control breakfast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI between 27 and 35 kg/m2 and/or waist circumference (>35 inches for women, >40 inches for men) Aged 55-70 years old Able to provide informed consent and comply with study procedures Willing to maintain stable body weight and follow his/her habitual diet and physical activity patterns throughout the trial. Judged by the Investigator to be in general good health on the basis of medical history and screening laboratory tests. Exclusion Criteria: Current smoker and/or marijuana user, past smokers may be allowed in the study if stopped >2 years Have a history or presence of atherosclerotic cardiovascular disease, inflammatory disease, diabetes mellitus, or other systemic diseases, psychological or psychiatric disorders Have recent surgery or injury to head Mini-Mental Status Exam score < 24 or Beck Depression Inventory score > 20 Taking any medications that would interfere with outcomes of the study (i.e., lipid-lowering medications, anti-inflammatory drugs, and supplements, not including multivitamin/mineral or calcium/Vit D supplements), Unstable use of any medication/supplement Have a history of cancer in the prior 5 years, except for non-melanoma skin cancer Addicted to drugs and/or alcohol (>2 drinks/day) Have been exposed to any non-registered drug product within last 30 days. Working overnight (e.g. 3rd shift of overnight workers) Excessive exercisers or trained athletes Have allergies/intolerances to berries. Vegetarian/vegan or have extreme dietary habits. Excessive coffee/tea drinker Actively losing weight/ trying to lose weight (unstable body weight fluctuations of > 5 kg in 3 months) Donated blood within last 3 months Female who is pregnant, planning to be pregnant, breastfeeding Current regular consumption of berries which exceeds > 2 servings per day The individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multi center, randomized, single-blind, 2-arm, placebo-controlled, within subject cross-over trial, featuring a repeated postprandial sampling paradigm
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>freeze-dried red raspberry powder (25 g) in active breakfast meal | Dietary Supplement: Active breakfast<br>* freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich<br>|
| Placebo Comparator: Placebo<br>Placebo breakfast | Dietary Supplement: Control breakfast<br>* Control drink + buttermilk biscuit sandwich<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Profile of Mood States response between 2 treatments | Cognitive assessment tasks will be performed in Profile of Mood States | Baseline to 6 hours | 
| Changes in Digit Symbol Coding response between 2 treatments | Cognitive assessment tasks will be performed in Digit Symbol Coding | Baseline to 6 hours | 
| Changes in Hopkins Verbal Learning Test response between 2 treatments | Cognitive assessment tasks will be performed in Hopkins Verbal Learning Test | Baseline to 6 hours | 
| Changes in CANTAB- paired-associates-learning response between 2 treatments | Cognitive assessment tasks will be performed in CANTAB- paired-associates-learning | Baseline to 6 hours | 
| Changes in CANTAB- rapid-visual-information-processing response between 2 treatments | Cognitive assessment tasks will be performed in CANTAB- rapid-visual-information-processing | Baseline to 6 hours | 
| Changes in CANTAB- spatial-working-memory response between 2 treatments | Cognitive assessment tasks will be performed in CANTAB- spatial-working-memory | Baseline to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Psychomotor function between 2 treatments | Psychomotor function will be measured with the Grooved Pegboard | Baseline to 6 hours | 
| Changes in postprandial endothelial function between 2 treatments | Vascular Assessments will be measured with Flow mediated vasodilation (FMD) | Baseline to 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Raspberry, Metabolic responses, Endothelial function, Cognitive function