Dietary Energy Restriction and Metabolic Aging in Humans
|First Received Date ICMJE||September 13, 2005|
|Last Updated Date||November 8, 2006|
|Start Date ICMJE||November 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Changes in body weight, body fatness and total energy expenditure at baseline, 3, 6, and 12 months of caloric restriction (CR).|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00183027 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Changes in blood pressure, insulin sensitivity and secretion, resting metabolic rate, bone mineral density, disease incidence, cognitive function, immune function, oxidative stress parameters, fertility hormones at baseline, 6, and 12 months|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Dietary Energy Restriction and Metabolic Aging in Humans|
|Official Title ICMJE||Dietary Energy Restriction and Metabolic Aging in Humans|
The purpose of this study is to develop an effective calorie restricted diet.
This study is a 3-phase investigation designed to test two caloric restriction (CR) regimens for participant compliance and variability in metabolic and physiologic effects. Initially, and through phase 1 (1 week pre-phase, and 6 weeks phase 1), participants will maintain normal habits at home.
Then for phase 2 (24 weeks), the 44 participants will be randomized to one of two diets (Diet HG or Diet LG), which they will consume at either 70% or 90% of baseline energy intake. The participants randomized to 90% CR (both diets) will form the control group. All food will be provided during this phase, and participants will be required to attend weekly group or individual meetings with the behavioral counselor and dietitian, and perform regular self-monitoring.
During phase 3 (24 weeks), participants will prepare their own food at home according to their CR regimen and will eat to maintain the CR specified for phase 2. They will continue to attend the weekly meetings and to perform self-monitoring.
Diet HG: a diet based on the USDA Food Guide Pyramid, but with additional emphasis on adequate fiber and low energy density foods, including use of whole grains rather than refined carbohydrates, limited liquid calories, high variety of low energy items such as fruits and vegetables and low variety of high-energy discretionary foods.
Diet LG: a modification of the HG diet in which low energy density is maintained even though the percent of energy from fat and protein is increased (by increased use of high-protein foods and foods with high water content) and use of different carbohydrate sources and physically intact food items (whole grains, raw fruits and vegetables) to further lower glycemic load through reducing the glycemic index (GI). High fiber intakes, low energy density, limited use of liquid calories, high variety of low energy items such as fruits and vegetables and low variety of high-energy discretionary foods will be the same as for the HG diet.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Intervention ICMJE||Behavioral: Dietary composition and energy intake|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 42 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00183027|
|Other Study ID Numbers ICMJE||AG0044, 3U01AG020480|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute on Aging (NIA)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institute on Aging (NIA)|
|Verification Date||November 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP