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Completed

NCT Number: NCT00942695

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

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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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

1.5PD

Other

average American diet plus 1.5 oz per day pistachios

3.0PD

Other

average American diet plus 3.0 oz per day pistachios

Control

Other

average American diet without pistachios

Primary outcomes

  1. to measure the energy value of pistachios in the human diet

    Time frame: 3 weeks

Secondary outcomes

  1. to study molecular mechanisms that may help explain the beneficial health effects of pistachios

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

United States Department of Agriculture (USDA)

Fed

Collaborators

  • Paramount Farms

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 21, 2009
Registry last updated
Feb 9, 2011

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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