Almond Butter and Fasting Glucose

Study Overview
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Brief Summary
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A two-period randomized crossover study will be conducted to determine the effect of almond butter as an evening snack on fasting blood glucose in adults with type 2 diabetes, not taking insulin.

Detailed Description
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Control of fasting blood glucose is a challenge for many individuals with diabetes. Researchers want to better understand how a nighttime snack can affect morning fasting blood glucose. A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 1 week. During the almond butter treatment, participants will consume 2 tbsp of almond butter per day as an evening snack. The control treatments will be a no-snack control. Fasting blood glucose, as well as glucose trends, will be measured using Continuous Glucose Monitor (CGM). Participants will also be asked to take simple cognitive tests on a study-provided smartphone each day of the study and report their daily food intake and physical activity.

Official Title
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Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Other: Almond Butter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with diagnosed type 2 diabetes Not on insulin therapy On stable does of oral antihyperglycemic agent (no dose change for 6 months) Currently monitoring blood glucose at home via glucometer 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 Allergy to any tree nut Liver or kidney disease Allergy to Dexcom CGM adhesive

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond Butter<br>Participants will consume one ounce per day ( 32 g) of almond butter as an evening snack (i.e., after dinner and before sleep). | Other: Almond Butter<br>* Natural almond butter<br>|
| No Intervention: No-snack Control<br>Participants will consume nothing besides water after dinner/bed sleep. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Glucose Measured Using Continuous Glucose Monitoring | Fasting glucose measures how much glucose (sugar) is in a blood sample after an overnight fast. In this study, fasting glucose was measured by continuous glucose monitoring (interstitial glucose); fasting window identified through review of glucose monitoring data to be 4am-6am. | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Trends | Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose) | 2 weeks | 
| Inhibitory Control Task (Percent Correct) | Go-NoGo task asked participants to press a button when a letter other than X was on screen and not press a button when X was present. | 2 weeks |