Status:
COMPLETED
The Measured Energy Value of Walnuts in the Human Diet
Lead Sponsor:
USDA Beltsville Human Nutrition Research Center
Collaborating Sponsors:
California Walnut Board
Conditions:
Metabolizable Energy of Walnuts
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief Summary
The objective of this study is to measure the energy value of walnuts in the human diet and study molecular mechanisms that may help explain the beneficial health effects of walnuts. The hypothesis is...
Detailed Description
Previous studies have demonstrated that nut consumption imparts a variety of health benefits, including reduction of cardiovascular disease and improved satiety. The aim of this study is to determine ...
Eligibility Criteria
Inclusion
- Age 25 to 65 years at beginning of study
- Body mass index 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
- Presence of kidney disease, liver disease, gout, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other metabolic diseases, or malabsorption syndromes
- Women who have given birth during the previous 12 months
- Pregnant women or women who plan to become pregnant or become pregnant during the study
- Lactating women
- 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
- Known (self-reported) allergy or adverse reaction to walnuts 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01832909
Start Date
April 1 2013
End Date
June 1 2013
Last Update
September 17 2013
Active Locations (1)
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1
USDA Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705