Almond Butter and Fasting Glucose

NCT ID: NCT03826472

Last Updated: 2024-04-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-08

Study Completion Date

2020-03-01

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.

Conditions

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Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Almond Butter

Intervention Type OTHER

Natural almond butter

No-snack Control

Participants will consume nothing besides water after dinner/bed sleep.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Almond Butter

Natural almond butter

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Penny M Kris-Etherton, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

Penn State

Locations

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Penn State

University Park, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PKE AlmondButter

Identifier Type: -

Identifier Source: org_study_id

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