Cleveland Clinic
Cleveland, Ohio, 44195, United States
NCT Number: NCT01411540
The purpose of this study is to compare a diet containing whole grains versus an energy matched diet using refined grains on body composition and metabolism.
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Notify Me20 year–50 year
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
The investigators hypothesis is that a diet high in whole-grains reduces abdominal fat. These findings might have clinical and public health significance for reducing obesity and related co-morbidities like type 2 diabetes and cardiovascular disease. Using a double-blind cross-over design, energy expenditure, body composition and metabolic health will be assessed. Three day inpatient study visits to the Cleveland Clinic Clinical Research Unit (CRU) will be implemented for metabolic control and testing. Total daily energy expenditure will be measured using the doubly labeled water (DLW) method. Body fat and glucose/protein metabolism will be assessed by imaging and isotope techniques, respectively. Blood, urine, and stool samples will also be collected for cardiometabolic and digestive health outcomes. After baseline testing, subjects will begin an 8 week dietary intervention, where all food and non-water beverages will be supplied by the study center. Dietary compliance will be assessed by weigh back measurements two times a week. To assess time course effects of diets differing in the amount of fiber on body composition and metabolic health, subjects will provide plasma and urine samples 2, 4, and 8 weeks after initial testing. Imaging and isotope analysis will be performed baseline and at week 8. All post testing will be conducted after week 8 following similar pre-testing control conditions. Subjects will then undergo an 8-10 week washout period where they will be instructed to return to their normal diet (except for any supplements). After the washout period, subjects will start the second arm of the intervention and consume the alternate diet (i.e. refined or whole grain diet). All energy expenditure, body composition and metabolic testing procedures will be repeated during the alternative arm of the study as described above.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Comparison of a diet containing whole grain compared to an energy matched diet based on similar foods, but using refined grains.
Other names: Diet, Body composition
Time frame: 24 months
The primary outcome is the change in body composition after an eight-week intervention of either whole grains or refined grains, corrected for baseline body composition at the start of the appropriate treatment arm.
Time frame: Eight-week cross-over trial with 10 week washout period between intervention arms.
DLW will be used to assess total daily energy expenditure (TDEE).
Time frame: Eight weeks
Glucose turnover will be assessed by [U-13C] glucose and [6,6-(2)H] glucose kinetics from breath, plasma and urine samples.
Time frame: Eight weeks
Protein turnover will be examined using 13C-leucine and 15N-glycine kinetics in breath, plamsa, and urine samples.
The Cleveland Clinic
Other
Effects of Diet on Body Composition
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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