Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427193
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2007-01-24
Brief Title:
CALERIE Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy CALERIE
Status:
COMPLETED
Status Verified Date:
2022-03
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 test the hypothesis that two years of sustained 25 caloric restriction CR in men age 21-50 inclusive and women age 21-47 inclusive will slow aging and protect against age-related disease processes
Detailed Description:
The overall aim of CALERIE Phase 2 is to test the hypothesis that two years of sustained caloric restriction CR involving a reduction in energy intake to 75 of baseline 25 CR in healthy non-obese men aged 21-50 inclusive and women aged 21-47 inclusive will result in the same adaptive changes that were observed in a wide variety of animal studies Particular emphasis is on the adaptive responses thought to be involved in slowing the aging process and protecting against age-related disease processes Primary outcomes include core body temperature and resting metabolic rate Secondary outcomes include risk factors for cardiovascular disease inflammatory markers immune function psychological and physical function oxidative changes in lipids proteins and DNA and risk factors for age-related conditions such as diabetes and body composition An important secondary aim is to identify potential adverse effects of CR in humans
The study will be conducted as a multi-center parallel-group randomized controlled trial RCT A sample of 200 participants will be enrolled and assigned to either the CR intervention or a control group Control participants will be advised to simply continue their current diets Participants in both treatment arms will be followed over a period of 24 months A comprehensive set of evaluations will be performed prior to initiating the intervention with follow-up evaluations at 1 3 6 9 12 18 and 24 months afterwards
The study will be conducted as a multi-center parallel-group randomized controlled trial RCT A sample of 200 participants will be enrolled and assigned to either the CR intervention or a control group Control participants will be advised to simply continue their current diets Participants in both treatment arms will be followed over a period of 24 months A comprehensive set of evaluations will be performed prior to initiating the intervention with follow-up evaluations at 1 3 6 9 12 18 and 24 months afterwards
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 |
|---|---|---|---|
| AG0078 | None | None | None |
| PBRC U01-AG0204878 | None | None | None |
| Tufts U01-AG020480 | None | None | None |
| WashU U01-AG020487 | None | None | None |
| DCRIDuke U01-AG022132 | None | None | None |