Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action - Full Text View

Sponsor:	United States Department of Agriculture
Collaborator:	Paramount Farms
Information provided by:	United States Department of Agriculture
ClinicalTrials.gov Identifier:	NCT00942695

Purpose

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.

Condition	Intervention
Energy Cardiovascular Disease Cancer	Other: 1.5PD Other: 3.0PD Other: control

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label
Official Title:	Energy Value of Macronutrients From Pistachio Nuts and Mechanisms of Nutrient Action

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

U.S. FDA Resources

Further study details as provided by United States Department of Agriculture:

Primary Outcome Measures:

to measure the energy value of pistachios in the human diet [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to study molecular mechanisms that may help explain the beneficial health effects of pistachios [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	October 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
base average American diet without pistachios	Other: control average American diet without pistachios
Active Comparator: 1.5PD average American diet plus 1.5 oz per day pistachios	Other: 1.5PD average American diet plus 1.5 oz per day pistachios
Active Comparator: 3.0PD average American diet plus 3.0 oz per day pistachios	Other: 3.0PD average American diet plus 3.0 oz per day pistachios

Detailed 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.

Eligibility

Ages Eligible for Study:	25 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942695

Locations

United States, Maryland
USDA-ARS, Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705

Sponsors and Collaborators

United States Department of Agriculture

Paramount Farms

Investigators

Principal Investigator:

David J Baer, Ph. D.

USDA-ARS

More Information

No publications provided

Responsible Party:	David J. Baer, Ph. D., Principal Investigator, USDA-ARS
ClinicalTrials.gov Identifier:	NCT00942695 History of Changes
Other Study ID Numbers:	2009-109
Study First Received:	July 17, 2009
Last Updated:	February 8, 2011
Health Authority:	United States: Federal Government

Keywords provided by United States Department of Agriculture:

pistachio
nuts
energy value
cardiovascular disease

phytonutrient
gene expression
energy value of pistachio nuts

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 09, 2012