Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577547
Status:
WITHDRAWN
Last Update Posted:
2023-01-11
First Post:
2020-06-18
Brief Title:
Food Activity and Behavior Study
Sponsor:
USDA Grand Forks Human Nutrition Research Center
Organization:
USDA Grand Forks Human Nutrition Research Center
Study Overview
Official Title:
Efficacy of the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans for Weight Control
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Never started
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAB
Brief Summary:
The purpose of this research is to test the effects of the Dietary and Physical Activity Guidelines for Americans on health and on eating and exercise behaviors
Detailed Description:
The Dietary Guidelines for Americans DGA which include the Physical Activity Guidelines for Americans PAGA is the primary United States US government resource for weight control The researchers propose that chronic low grade inflammation CLGI limits weight control by acting upon physiological and behavioral factors that moderate weight control Diet and exercise reduce CLGI and provide weight control but no one has investigated the efficacy of the DGA and PAGA to reduce CLGI whether reduced CLGI promotes greater weight control and the moderating roles of physiological and behavioral factors on the association of reduced CLGI with weight control To accomplish this the researchers will conduct a 6-month trial in 224 obese adults a 3-month controlled feeding trial with four dietary arms 1 DGA with weight loss 2 Western diet with weight loss3 DGA diet weight maintenance 4 Western diet weight maintenance Each dietary arm will have PAGA-recommended exercise and non-exercise arms Post-trial is a 3-month weight maintenance period The primary outcome is change in C-reactive protein CRP a marker of CLGI The results will inform the DGA and PAGA thereby helping clinicians public health workers and policymakers to improve the health of Americans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None