Almond Butter and Fasting Glucose

Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Other: Almond Butter

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Penn State

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Almond Butter; 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; Natural almond butter
No Intervention: No-snack Control; Participants will consume nothing besides water after dinner/bed sleep.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Penn State University
• Investigators: Principal Investigator: Penny M Kris-Etherton, PhD, RDN, Penn State

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: PKE AlmondButter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes