Pistachios Blood Sugar Control, Heart and Gut Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-09

Study Completion Date

2022-11-17

Brief Summary

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A two-period randomized crossover study will be conducted to evaluate the effect of nighttime pistachio consumption (i.e., after dinner and before sleep) on fasting blood sugar levels, longer-term blood sugar control, and risk factors for heart disease. This study will also investigate how pistachios affects gut health.

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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 12 weeks followed by a minimum 4-week wash-out period. During the pistachio treatment, participants will consume two ounces per day (57 g) of pistachios as an evening snack. During the control phase subjects will be given advice to consume 1-2 exchanges of carbohydrate as an evening snack, which is consistent with usual care. 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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Type 2 Diabetes Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover assignment

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Evening Pistachio Consumption

Participants will consume two ounces per day (57 g) of pistachios as an evening snack (i.e., after dinner and before sleep).

Group Type ACTIVE_COMPARATOR

Pistachio

Intervention Type DRUG

Unsalted pistachios

Usual care

Advice to consume a snack that contains 1-2 exchanges (15-30 g of carbohydrate) as an evening snack - this is consistent with the current standard of care for people with impaired fasting glucose.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Advice and resources will be provided

Interventions

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Pistachio

Unsalted pistachios

Intervention Type DRUG

Usual care

Advice and resources will be provided

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* BMI ≥25 and ≤45 kg/m2
* Fasting plasma glucose 100 - 125 mg/dL
* non-Smoking

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
* Women who are pregnant, lactating, planning to become pregnant or have given birth in the past year
* 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/intolerance/sensitive to pistachios
* Consumption of \>14 alcoholic drinks/week
* Shift-workers and those who cannot consume a snack in the evening

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes