Peanuts and Glycemic Control

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-12-20

Brief Summary

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A two-period randomized crossover study will be conducted to determine the effect of peanuts on glycemic control, and elucidate the role of the microbiome in glucose regulation, in individuals with impaired fasting glucose.

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Detailed Description

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A two-period randomized crossover trial will be conducted. Participants will be randomized to receive each treatment for 6 weeks followed by a minimum 4-week wash-out period. During the peanut treatment, participants will consume one ounce per day (28 g) of peanuts as an evening snack. The control treatments will be an isocaloric higher carbohydrate snack consumed after the evening meal. Markers of glycemic control, cardiovascular risk factors and gut health will be assessed at the beginning and the end of each treatment period.

Conditions

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Type2 Diabetes Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Evening Peanut Consumption

Participants will consume one ounce per day (28 g) of peanuts as an evening snack (i.e., after dinner and before sleep).

Group Type EXPERIMENTAL

Peanut

Intervention Type DRUG

Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.

Evening Snack

Participants will consume an isocaloric higher carbohydrate snack as an evening snack (i.e., after dinner and before sleep).

Group Type ACTIVE_COMPARATOR

High carbohydrate snack

Intervention Type DRUG

Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).

Interventions

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Peanut

Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.

Intervention Type DRUG

High carbohydrate snack

Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Non-smoking
* Impaired fasting glucose at screening (≥ 100 mg/dL).
* BMI ≥20 and ≤40 kg/m2.

Exclusion Criteria

* Diagnosed diabetes or fasting glucose \>126 mg/dl
* Systolic blood pressure \>160mmHg or diastolic blood pressure \>100mmHg)
* Prescribed anti-hypertensive, lipid lowering or glucose lowering drugs
* Established cardiovascular disease, stroke, diabetes, liver, kidney or autoimmune disease or inflammatory conditions
* Use of supplements (psyllium, fish oil, soy lecithin, phytoestrogens) and botanicals and not willing to cease for the duration of the study
* Pregnancy or lactation
* Weight loss of \>=10% of body weight within the 6 months prior to enrolling in the study
* Smoking or use of any tobacco products
* Allergy to test foods
* Consumption of \>14 alcoholic drinks/week

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes