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

U

United States Department of Agriculture (USDA)

Status

Completed

Conditions

Energy
Cancer
Cardiovascular Disease

Treatments

Other: control
Other: 3.0PD
Other: 1.5PD

Study type

Interventional

Funder types

Other U.S. Federal agency
Other

Identifiers

NCT00942695
2009-109

Details and patient eligibility

About

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.

Full description

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.

Enrollment

15 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

15 participants in 3 patient groups

base
Other group
Description:
average American diet without pistachios
Treatment:
Other: control
1.5PD
Active Comparator group
Description:
average American diet plus 1.5 oz per day pistachios
Treatment:
Other: 1.5PD
3.0PD
Active Comparator group
Description:
average American diet plus 3.0 oz per day pistachios
Treatment:
Other: 3.0PD

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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