Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:07 AM
Study NCT ID:
NCT07355933
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2025-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Flexibility and Metabolic Heath in Human Obesity
Sponsor:
Jose Galgani
Organization:
Study Overview
Official Title:
Metabolic Flexibility, Eating Behavior and Adipose Tissue Expandability: Role of This Triad in the Propensity to Human Obesity
Status:
COMPLETED
Status Verified Date:
2026-02
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:
PROB
Brief Summary:
This interventional study explores the relationship between improvements in metabolic health following weight loss and changes in whole-body fat mass and its distribution. The study focuses on adult men and women with excess body weight undergoing dietary energy restriction over 12 weeks. The primary research question is: Does a greater reduction in fat mass for a given weight loss correlate with more significant improvements in metabolic health?
Detailed Description:
Obesity is a well-established risk factor for disruptions in metabolic health, which often precede cardiovascular disease and type-2 diabetes. While the precise pathophysiological mechanisms linking obesity to these conditions remain unclear, it is widely acknowledged that an increase in fat mass plays a central role, including the expansion of adipose tissue and the accumulation of lipids in non-adipose tissues. As a result, a primary approach to improving metabolic health is to reduce fat mass through negative energy balance. However, lifestyle changes or pharmacological interventions aimed at inducing a negative energy balance do not exclusively target fat mass and often result in the loss of fat-free mass to varying degrees. Given that higher fat mass, rather than fat-free mass, is more strongly associated with impaired metabolic health, strategies that maximize fat mass loss while preserving fat-free mass may offer more significant benefits for metabolic health. Surprisingly, there is a lack of evidence to support this hypothesis. To address this gap, it will be evaluated the relationship between changes in metabolic health and body composition, independent of overall weight loss, in individuals with overweight or obesity undergoing dietary energy restriction. It is hypothesized that greater fat mass reduction will be linked to more substantial improvements in metabolic health for a given weight loss.
Study Oversight
Has Oversight DMC:
False
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?: