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

NCT00942695 | Completed DMC

• 1 other identifier: 2009-109
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Energy; Cardiovascular Disease; Cancer

Keywords

pistachio; nuts; energy value; cardiovascular disease; phytonutrient; gene expression; energy value of pistachio nuts

Outcome Measures

Primary Outcomes (1)

• to measure the energy value of pistachios in the human diet

  3 weeks

Secondary Outcomes (1)

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

  3 weeks

Study Arms (3)

base

OTHER

average American diet without pistachios

Other: control

1.5PD

ACTIVE COMPARATOR

average American diet plus 1.5 oz per day pistachios

Other: 1.5PD

3.0PD

ACTIVE COMPARATOR

average American diet plus 3.0 oz per day pistachios

Other: 3.0PD

Interventions

1.5PD OTHER

average American diet plus 1.5 oz per day pistachios

1.5PD

3.0PD OTHER

average American diet plus 3.0 oz per day pistachios

3.0PD

control OTHER

average American diet without pistachios

base

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• United States Department of Agriculture (USDA): lead
• Paramount Farms: collaborator

Study Sites (1)

USDA-ARS, Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Neoplasms

Study Officials

• David J Baer, Ph. D.

  United States Department of Agriculture (USDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 21, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 9, 2011

Record last verified: 2011-02

Locations

US (1)