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Completed

NCT Number: NCT03826472

Almond Butter and Fasting Glucose

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.

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Key information

Conditions

Type2 Diabetes

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Penn State

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Almond Butter

Other

Natural almond butter

Primary outcomes

  1. Fasting Glucose Measured Using Continuous Glucose Monitoring

    Time frame: 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 outcomes

  1. Glucose Trends

    Time frame: 2 weeks

    Overnight (12pm-4am) mean blood sugar values measured by continuous glucose monitoring (interstitial glucose)

  2. Inhibitory Control Task (Percent Correct)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Almond Butter and Fasting Glucose in Adults With Type 2 Diabetes

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 1, 2019
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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