Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2026-03-13 @ 6:55 AM
Study NCT ID:
NCT03696966
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2018-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KU Alternate Meal Energy Level Study
Sponsor:
University of Kansas Medical Center
Organization:
Study Overview
Official Title:
KU Alternate Meal Energy Level Study
Status:
COMPLETED
Status Verified Date:
2019-01
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:
KAMEL
Brief Summary:
Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.
Detailed Description:
The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
Study Oversight
Has Oversight DMC:
True
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?: