Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00942695
Other study ID # 2009-109
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT05346796 - Survivorship Plan HEalth REcord (SPHERE) Implementation Trial N/A
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT04867850 - Effect of Behavioral Nudges on Serious Illness Conversation Documentation N/A
Enrolling by invitation NCT04086251 - Remote Electronic Patient Monitoring in Oncology Patients N/A
Completed NCT01285037 - A Study of LY2801653 in Advanced Cancer Phase 1
Completed NCT00680992 - Study of Denosumab in Subjects With Giant Cell Tumor of Bone Phase 2
Completed NCT00062842 - Study of Irinotecan on a Weekly Schedule in Children Phase 1
Active, not recruiting NCT04548063 - Consent Forms in Cancer Research: Examining the Effect of Length on Readability N/A
Completed NCT04337203 - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship N/A
Recruiting NCT04349293 - Ex-vivo Evaluation of the Reactivity of the Immune Infiltrate of Cancers to Treatments With Monoclonal Antibodies Targeting the Immunomodulatory Pathways N/A
Terminated NCT02866851 - Feasibility Study of Monitoring by Web-application on Cytopenia Related to Chemotherapy N/A
Active, not recruiting NCT05304988 - Development and Validation of the EFT for Adolescents With Cancer
Completed NCT04448041 - CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
Completed NCT00340522 - Childhood Cancer and Plexiform Neurofibroma Tissue Microarray for Molecular Target Screening and Clinical Drug Development
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Active, not recruiting NCT03844048 - An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial Phase 3
Completed NCT03167372 - Pilot Comparison of N-of-1 Trials of Light Therapy N/A
Completed NCT03109041 - Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source Phase 1
Terminated NCT01441115 - ECI301 and Radiation for Advanced or Metastatic Cancer Phase 1
Recruiting NCT06206785 - Resting Energy Expenditure in Palliative Cancer Patients