Cancer Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | USDA-ARS, Beltsville Human Nutrition Research Center | Beltsville | Maryland |
Lead Sponsor | Collaborator |
---|---|
United States Department of Agriculture (USDA) | Paramount Farms |
United States,
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 |
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