Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2005-09-30
2009-06-30
Brief Summary
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We will conduct a controlled feeding study (all food will be provided for the duration of the study) in which obese adults will be randomly assigned to one of three dietary groups: a low-carbohydrate-eat as much as you like diet, a high-carbohydrate-eat as much as you like diet, or a high-carbohydrate-calorie-restricted diet. The low-carbohydrate diet will be modeled after the Induction Phase of the Atkins Diet. The high carbohydrate diet will be based on the "Dietary Approaches to Stop Hypertension (DASH)" diet. During the first 3 weeks, participants will eat a typical diet adjusted so that they neither gain or lose weight. Then, for 6 weeks, they will eat their assigned research diet. Resting calorie use and body composition measurements will be taken at the end of week 2 and week 9. Frequent blood sampling for 24 hours will be done through a catheter (tube) placed in an arm vein at the end of weeks 2 and week 9 and for 12 hours at the end of week 3.
Change in body composition, activity and energy expenditure, and blood components known to influence eating behavior will be measured under typical diet conditions and after one-day and 6 weeks of the research diet.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low carbohydrate diet
6 week ad libitum low carbohydrate diet; research diet provided at 120% of estimated energy requirement for weight maintenance; carbohydrate intake limited to 28g/d
Low carbohydrate diet
Ad libitum low carbohydrate diet (\<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.
High Carbohydrate Diet-ad libitum
High complex carbohydrate diet (55% carbohydrate, 18% protein, 27% fat. 120% of estimated energy needs for weight maintenance provided, participants allowed to eat as much or as little as desired to satisfy appetite
High-carbohydrate ad libitum intervention
Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired
High Carbohydrate Diet-Energy-matched
High carbohydrate diet (55% carbohydrate, 18% protein and 27% fat). Energy intake restricted to \~68% of energy needs for weight maintenance. Participants required to eat all food provided and nothing else
High carbohydrate diet-energy matched intervention
Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at \~70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.
Interventions
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Low carbohydrate diet
Ad libitum low carbohydrate diet (\<28g carbohydrate/day). Participants provided with research diet at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the food desired.
High-carbohydrate ad libitum intervention
Participants provided with a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at 120% of estimated energy needs for weight maintenance and allowed to eat as much or as little of the foods provided as desired
High carbohydrate diet-energy matched intervention
Participants provided a high complex carbohydrate diet (55% carbohydrate, 18% protein, and 27% fat) at \~70% of estimated energy needs to maintain weight. Participants required to eat all food provided and nothing else.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age at least 21 years
* Relative good health
Exclusion Criteria
* Renal or hepatic disease, diabetes
* History of gallbladder disease/removal
* Hyper-or hypothyroidism
* Poorly controlled hypertension
* Use of lipid lowering medications
* Pregnancy or lactation
* Current excessive use of alcohol
* Current/recent chronic use of tobacco
21 Years
65 Years
ALL
Yes
Sponsors
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Kaiser Permanente
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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OHSU
Principal Investigators
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Diane D Stadler, PhD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Other Identifiers
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