Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183027
Status:
COMPLETED
Last Update Posted:
2006-11-09
First Post:
2005-09-13
Brief Title:
Dietary Energy Restriction and Metabolic Aging in Humans
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Dietary Energy Restriction and Metabolic Aging in Humans
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to develop an effective calorie restricted diet
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 3U01AG020480 | NIH | None | httpsreporternihgovquickSearch3U01AG020480 |