Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action

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

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2009-12-31

Brief Summary

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The objective of this study is to measure the energy value of pistachios in the human diet and study molecular mechanisms that may help explain the beneficial health effects of pistachios.

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Detailed Description

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Previous studies have suggested that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. However, studies of pistachios are extremely limited. The aim of this study is to determine the energy value of pistachios in the human diet and to probe mechanisms by which pistachios impart health benefits. The metabolizable energy value of pistachio nuts will be calculated based on the chemical composition and energy content of the consumed diet and excreta. This will provide a better estimate of the energy value of pistachios than simply calculating energy value based on Atwater factors. In addition to determining the energy value of pistachios, we will evaluate the effects of pistachio-rich diets on plasma phytonutrient levels and on gene expression changes to determine what protective mechanisms are activated by pistachio consumption.

Conditions

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Energy Cardiovascular Disease Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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base

average American diet without pistachios

Group Type OTHER

control

Intervention Type OTHER

average American diet without pistachios

1.5PD

average American diet plus 1.5 oz per day pistachios

Group Type ACTIVE_COMPARATOR

1.5PD

Intervention Type OTHER

average American diet plus 1.5 oz per day pistachios

3.0PD

average American diet plus 3.0 oz per day pistachios

Group Type ACTIVE_COMPARATOR

3.0PD

Intervention Type OTHER

average American diet plus 3.0 oz per day pistachios

Interventions

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1.5PD

average American diet plus 1.5 oz per day pistachios

Intervention Type OTHER

3.0PD

average American diet plus 3.0 oz per day pistachios

Intervention Type OTHER

control

average American diet without pistachios

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 25 to 65 years at beginning of study
* BMI between 20 and 38 kg/m2
* Fasting glucose \< 126 mg/dl
* Blood pressure \< 160/100 (controlled with certain medications)
* Fasting total blood cholesterol \< 280 mg/dl
* Fasting triglycerides \< 300 mg/dl

Exclusion Criteria

* Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* History of bariatric or certain other surgeries related to weight control
* Smokers or other tobacco users (during 6 months prior to the start of the study)
* Antibiotic use during the intervention or for 3 weeks prior to any intervention period
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
* Known (self-reported) allergy or adverse reaction to pistachios or other nuts
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes