Almond Butter and Fasting Glucose

Type2 Diabetes Clinical Trial

Official title:

Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826472
• Other study ID #: PKE AlmondButter
• Status: Completed
• Phase: Phase 2
• Start date: March 8, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: April 2024
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• Almond Butter
Natural almond butter

Locations

Country	Name	City	State
United States	Penn State	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Glucose Trends	Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose)	2 weeks
Secondary	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