Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099138
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2004-12-08
Brief Title:
CALERIE Washington University Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Caloric Restriction and Aging in Humans
Status:
COMPLETED
Status Verified Date:
2006-02
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:
This study is one of three CALERIE trials that test the hypothesis that a reduced calorie nutritionally sound diet increases the length of life and prevents some age-related chronic diseases such as cancer diabetes and cardiovascular disease The three sites that are participating in the CALERIE trial represent a diversity of subject populations and interventional strategies
Detailed Description:
Animal studies suggest that caloric restriction CR or consuming fewer calories increases life span and also protects against some aging-related disease processes such as artherosclerosis and type II diabetes However it appears that simply burning more calories through physical activity does not increase life span by itself It is not known how CR affects humans but based on this evidence it appears that the reduced total intake and metabolism of food is the main factor rather than increased exercise alone
To test this volunteers will be placed on a program of either 20 caloric restriction or 20 increase of energy expenditure by exercise or in a control group to be instructed in healthy living All will be evaluated on a number of potential markers of aging on body composition and on risk factors for artherosclerosis and diabetes
Participation in the study will last for 12 months The Diet group will receive individual instruction from a registered dietician The Exercise group will be given an individualized exercise program created by a personal trainer The Healthy Lifestyle group will be given information on how to make healthier choices both diet and activity will be discussed All participants will be measured every two weeks and will keep daily food and activity logs All will be seen by a physician and will have lab tests done before beginning the study at 1 month and then 3 month intervals
To test this volunteers will be placed on a program of either 20 caloric restriction or 20 increase of energy expenditure by exercise or in a control group to be instructed in healthy living All will be evaluated on a number of potential markers of aging on body composition and on risk factors for artherosclerosis and diabetes
Participation in the study will last for 12 months The Diet group will receive individual instruction from a registered dietician The Exercise group will be given an individualized exercise program created by a personal trainer The Healthy Lifestyle group will be given information on how to make healthier choices both diet and activity will be discussed All participants will be measured every two weeks and will keep daily food and activity logs All will be seen by a physician and will have lab tests done before beginning the study at 1 month and then 3 month intervals
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 |
|---|---|---|---|
| 3U01AG020487 | NIH | None | httpsreporternihgovquickSearch3U01AG020487 |