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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942695
• Other study ID #: 2009-109
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: February 8, 2011
• Start date: October 2009
• Est. completion date: December 2009

Study information

• Verified date: February 2011
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Disease
• Cardiovascular Diseases
• Energy

Intervention

Other:
• 1.5PD
average American diet plus 1.5 oz per day pistachios
• 3.0PD
average American diet plus 3.0 oz per day pistachios
• control
average American diet without pistachios

Locations

Country	Name	City	State
United States	USDA-ARS, Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
United States Department of Agriculture (USDA)	Paramount Farms

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to measure the energy value of pistachios in the human diet		3 weeks	No
Secondary	to study molecular mechanisms that may help explain the beneficial health effects of pistachios		3 weeks	No