Almond Butter and Fasting Glucose

Phase 2

Completed

• Conditions: Type2 Diabetes

• Registration Number: NCT03826472
• Lead Sponsor: Penn State University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-01-30
• Study First Posted: 2019-02-01
• Study Start: 2019-03-08
• Primary Completion: 2020-03-01
• Study Completion: 2020-03-01
• Results First Submitted: 2021-10-04
• Results First Submitted QC: 2023-11-08
• Results First Posted: 2023-11-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Fasting Glucose Measured Using Continuous Glucose Monitoring	2 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Inhibitory Control Task (Percent Correct)	2 weeks	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.
Glucose Trends	2 weeks	Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose)

Trial Locations

Locations (1)

Penn State; 🇺🇸 University Park, Pennsylvania, United States