Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2025-12-17 @ 7:38 AM
Study NCT ID:
NCT06395246
Status:
None
Last Update Posted:
2024-10-04 00:00:00
First Post:
2024-04-24 00:00:00
Brief Title:
Circulating Microvesicles Regulating Metabolic Homeostasis in Obesity After Caloric Restriction Programs
Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Organization:
Institut Investigacio Sanitaria Pere Virgili
Study Overview
Official Title:
The Usefulness of Circulating Microvesicles (host and Bacterial) in Regulating Metabolic Homeostasis in Obesity Randomized Study of Parallel Arms in Obese Patients Undergoing Caloric Restriction Diet Vs. Early Time-restricted Eating
Status:
None
Status Verified Date:
2024-10
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:
TREV
Brief Summary:
The specific objectives are:
1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.
2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.
3. Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.
The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.
1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects.
2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones.
3. Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects.
The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.
Detailed Description:
The specific objectives are
1 To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects
2 Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones
3 Define the digital footprint of EVs as inter-organ communication elements influencing metabolic status in obese subjects
The study design comprises a randomized parallel-arm design n40 with consecutive 11 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction DCR n20 or an eTRE protocol n20 for 12 weeks Clinical and analytical variables adherence satiety chronotype and brown fat content will be determined before and at the end of the follow-up Derivatives of intestinal microbiota short-chain fatty acids bile acids and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics Glucagon-like peptide 1 GLP1 and gastric inhibitory polypeptide GIP dynamics after a standard meal test Metagenomics Bioenergetic analysis of PBMC by SeaHorse Total EV miRNA profile Isolation of host and bacterial EVs Characterization of the protein cargo of host and bacterial EVs
1 To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects
2 Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones
3 Define the digital footprint of EVs as inter-organ communication elements influencing metabolic status in obese subjects
The study design comprises a randomized parallel-arm design n40 with consecutive 11 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction DCR n20 or an eTRE protocol n20 for 12 weeks Clinical and analytical variables adherence satiety chronotype and brown fat content will be determined before and at the end of the follow-up Derivatives of intestinal microbiota short-chain fatty acids bile acids and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics Glucagon-like peptide 1 GLP1 and gastric inhibitory polypeptide GIP dynamics after a standard meal test Metagenomics Bioenergetic analysis of PBMC by SeaHorse Total EV miRNA profile Isolation of host and bacterial EVs Characterization of the protein cargo of host and bacterial EVs
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