Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes
Phase: PHASE2
Conditions: Type2 Diabetes
Sponsor: Penn State University

 
 
 
 
Protocol for Almond Butter and Fasting Glucose Study 
 
Identifiers: NCT03826472    
Unique Protocol ID: PKE AlmondButter 
Brief Title: Almond Butter and Fasting Glucose 
Updated May 2, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Protocol for Almond Butter and Fasting Glucose Study 
 
Inclusion Criteria 
• Individuals 18 to 75 years of age 
• Individuals with diagnosed type 2 diabetes 
• HgbA1c: <9% 
• Not on insulin therapy 
• On stable does of oral antihyperglycemic agent (no dose change for 6 
• months) or no oral antihyperglycemic agents 
• Willing and able to adhere to study protocol 
Exclusion Criteria 
• Individuals with type 1 diabetes, cardiovascular disease, kidney disease, liver 
• disease, cancer or inflammatory conditions (e.g. GI disorders, rheumatoid 
• arthritis) 
• Women who are pregnant, breastfeeding, or have been pregnant within the 
• last 6 months or breastfeeding within the last 6 weeks 
• Individuals who smoke or use tobacco products 
• Use of insulin therapy or sulfonylurea medications 
• Almond allergy 
• Allergy to Dexcom CGM adhesive 
Recruitment 
Advertisements will be placed in campus buildings and facilities as well as the 
surrounding area (gyms, churches, supermarkets, coffee shops etc.) to identify 
potential subjects residing in and around the State College area. We will also 
provide flyers to local physician offices and recruit through our Facebook page 
and department website. 
Study staff will contact those individuals who have responded to ads (email, 
newspaper, website, fliers) and have left their name and phone numbers on the 
recruiting line or email. 
 
Recruitment flyers will be posted in local physician offices. Cardstock fliers may 
also be distributed to patients or displayed in the waiting room of the office. 
Websites (http://clinicaltrials.gov/, https://studyfinder.psu.edu/, Facebook, Craig's 
List), PSU listserv (Health and Human Development Dept listserv; Food Science 
listserv; post-doc etc.) will also be utilized. Participants will be asked to complete 
a brief phone screening to confirm eligibility. 
Consent Process and Documentation 
Once interested participants have contacted study staff and have undergone a 
phone screening, an appointment will be set at the General Clinical Research 

Center (GCRC) where study staff will review the consent documents with 
participants. At this appointment, before any procedures take place, potential 
participants will be given the informed consent document. Following standard 
protocol procedure, a trained staff person will review the information in detail, 
make sure the individual understands the study and answers any questions they 
may have. If the participant is still interested in enrolling in the study, both the 
participant and the staff member will sign and date the document. A copy of the 
signed document will be provided to the participant prior to leaving the screening 
appointment. If consent is obtained, the study protocol will reviewed, the Dexcom 
monitor will be placed, and the subject will begin the study that day. Subjects will 
be made aware that their participation in this study is voluntary, they may drop 
out of the study at any time, and that there is no penalty for not participating. 
Consent will be confirmed in writing. 
Protocol 
After completion of the phone screening, an appointment will be set for a 
baseline visit at the GCRC to obtain informed consent and place the continuous 
glucose monitor. If the participant consents to the research, the researcher will 
play a brief video detailing how to use place a Dexcom Continuous Glucose 
Monitor (CGM), and participants will will then place the monitor on themselves, 
under the supervision of study staff. Participants will be taught to use the CGM 
properly and will wear it for 3-7 days. The CGM can be worn for up to 7 days, 
according to manufacturers’ instruction, but in some individuals, the adhesive 
does not stay in place for the full week. We will plan for study participants to wear 
the CGM for 7 days, but we will accept a minimum of 3 days of data. 
The Continuous Glucose Monitor data receiver will be set to blinded mode and 
participants will not be able to see their glucose data for the duration of 
participation (they will still monitor their blood glucose as instructed by their 
physician, they just will not be able to see it on the CGM). Participants will wear 
the CGM for 3-7 days, return to the clinic for removal and replacement, and then 
begin the second study period. They will also be provided with the study food, 
almond butter, and be asked to consume the almond butter that we provide to 
them as a bedtime snack for the 3-7 nights of the study. The order of their 
treatment (control then almond butter or almond butter then control) will be 
randomly assigned. We will also ask participants to keep a record of what they 
eat for dinner, what time they eat breakfast, lunch and snacks, and any changes 
in medication or physical activity on those days. Participants will receive 
individual packets of 2 tbsp of natural almond butter and be given instructions to 
eat the almond butter as an evening snack, or to eat nothing after dinner during 
the no-snack control period. Blood glucose levels will be measured using 
continuous glucose monitoring (CGM), which will be provided free of charge to 
participants through a donation from Dexcom. At Visit 3, participants will have the 
CGM removed and will receive a printout of their CGM data when they return the 
Dexcom equipment to the office. 
Visit 1 

The study will be explained, questions will be answered and consent forms will 
be reviewed and signed. Participants providing consent will watch a brief video 
on use and placement of CGM, and then place their CGM in the office, 
supervised by study staff. They will be taught to use the CGM, be provided with 
the study food, food record sheets and randomized. They will also have an 
appointment set for 6-14 days later. 
Visit 2 
At the second visit, participants will remove and replace their CGM monitor. They 
will be reminded of all data entry requests. 
Visit 3 
At the third visit, participants will return their CGM equipment and their data will 
be downloaded. They will receive their CGM data and be entered into a drawing 
to win a gift card for their participation. They will receive the $100 incentive for 
participation approximately two weeks later. 
Duration of Participation 
Participants will first complete a phone screening. If they are deemed eligible, 
they will participate in the study for 2 weeks, including 3 visits to the clinic. Visit 1 
lasts approximately 1 hour, visits 2 and 3 last approximately 15 minutes. 
Intervention Food (Almond Butter) 
The almond butter will be packaged into 7 single serving containers to be 
consumed during the intervention week. Participants will be given individual 
containers as dictated by the study design, 1 per day, for the duration of the 
intervention, at their first visit. There are no special requirements for storage by 
the participants. 
Subject Numbers and Statistical Plan 
Ten participants were recruited for this study. All data collected, including CGM 
and dietary data, will be identified with a code. None of the collected data will 
include patient identifiers. Only the PI and study personnel will have access to 
study data. Linear mixed effect models in R statistical software (The R Project for 
Statistical Computing) will be used to analyze the data.