Ignite Creation Date:
2024-05-06 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03411356
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2018-01-04
Brief Title:
Intermittent Fasting Versus Daily Caloric Restriction for Weight Loss
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Comparison of Weight Loss Induced by Intermittent Fasting Versus Daily Caloric Restriction in Individuals With Obesity A 1-Year Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-02
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:
The primary aim of this study is to is to determine if intermittent fasting IMF is an effective dietary strategy for treatment of obesity A 1 year randomized trial will be used to compare weight loss generated by IMF versus Daily Caloric Restriction DCR The targeted weekly energy deficit is designed to be similar 30 and a comprehensive behavioral support program will be provided to both groups The primary outcome is weight change at the end of the 1 year intervention follow up measures will also be obtained 6 months after completing the intervention This study will provide robust data regarding weight loss effectiveness of IMF and will further our understanding of the impact of IMF on energy balance
Detailed Description:
Restricting daily calorie intake is the primary dietary strategy currently used to treat obesity However this approach is not effective for all individuals Further adherence to daily caloric restriction DCR typically decreases over time and many individuals who lose weight with this strategy will regain Thus novel dietary interventions are needed to provide a broader range of treatment options The objective of this proposal is to determine if intermittent fasting IMF is an effective dietary strategy for treatment of obesity IMF is an alternative method of reducing energy intake EI which has gained lay popularity in recent years as a strategy for weight loss Short-term studies suggest IMF produces 3-8 weight loss in individuals with overweight and obesity However few studies have compared IMF to DCR and no studies have evaluated whether IMF is an effective long-term 1 year weight loss strategy Data from an 8-week pilot study comparing IMF to DCR suggests IMF is safe tolerable and produces similar short-term weight loss After 6 months of unsupervised follow-up changes in body composition tended to be more favorable with IMF and almost twice as many IMF participants maintained a 5 kg weight loss Thus IMF may be a more effective dietary strategy for sustaining weight loss than DCR However longer-term data are needed and little is known about adherence to IMF or the impact of IMF on energy expenditure EE Short-term studies suggest adherence to IMF may be superior to DCR however energy intake EI was based on self-report which may have significant limitations Pilot data suggests resting energy expenditure REE was preserved during IMF-induced weight loss which could decrease risk for weight regain However the impact of IMF on other components of EE including physical activity PA is largely unexamined The study design is a pragmatic randomized trial to compare weight loss generated by IMF vs DCR The targeted weekly energy deficit will be equivalent DCR will be prescribed a 30 daily energy restriction and IMF will be prescribed a modified fast 80 energy restriction on 3 non-consecutive days per week The hypothesis is that a weight loss program based on IMF as the primary dietary strategy will result in greater weight loss at 1 year compared to a program based on traditional DCR The approach is innovative as the targeted energy deficit will be matched between groups and EI will be assessed objectively using doubly-labeled water to provide an accurate comparison of adherence In addition both intervention groups will receive guidelines-based behavioral support to compare IMF to the current standard of care DCR in a more robust fashion This study is significant as it could identify an effective alternative dietary strategy to help more people achieve and sustain weight loss
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK111622-01A1 | NIH | None | httpsreporternihgovquickSearchR01DK111622-01A1 |