Ignite Creation Date:
2024-05-06 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05031572
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2021-08-20
Brief Title:
Energy -Sensing Metabolites in Caloric Restriction
Sponsor:
Institut Investigacio Sanitaria Pere Virgili
Organization:
Institut Investigacio Sanitaria Pere Virgili
Study Overview
Official Title:
New Energy-sensing Metabolites Beneficial Effects on Metabolic Health in Obesity Comparing Diary Caloric Restriction vs Intermittent Fasting A Randomized Cross-over Study
Status:
COMPLETED
Status Verified Date:
2022-10
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:
None
Brief Summary:
General integrated goal of the coordinated project
To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids SCFAs as energy sensing metabolites in the context of obesity and type 2 diabetes T2D
Specific objectives of Subproject 1 SP1 1a - To investigate whether intermittent fasting IF is better than Continued Daily Caloric Restriction DCR in terms of metabolic improvement through the study of 1 the dynamics of gastrointestinal hormones and energy sensing metabolites 2 the intestinal microbiome 3 variability on succinate and SCFAs MCFAs and Biliary Acid after weight loss Methodology clinical study randomized cross-over design study participants n15 will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet DCR or will undertake an intermittent IF protocol Clinical anthropometrical and functional studies Metabolomics for gut derived metabolites in plasma Enteroendocrine gastrointestinal dynamics Metagenomic analysis
To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids SCFAs as energy sensing metabolites in the context of obesity and type 2 diabetes T2D
Specific objectives of Subproject 1 SP1 1a - To investigate whether intermittent fasting IF is better than Continued Daily Caloric Restriction DCR in terms of metabolic improvement through the study of 1 the dynamics of gastrointestinal hormones and energy sensing metabolites 2 the intestinal microbiome 3 variability on succinate and SCFAs MCFAs and Biliary Acid after weight loss Methodology clinical study randomized cross-over design study participants n15 will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet DCR or will undertake an intermittent IF protocol Clinical anthropometrical and functional studies Metabolomics for gut derived metabolites in plasma Enteroendocrine gastrointestinal dynamics Metagenomic analysis
Detailed Description:
To investigate whether IF is better than DCR in terms of metabolic improvement through the study of
1 the dynamics of gastrointestinal hormones and energy sensing metabolites
2 the intestinal microbiome
3 variability on succinate and SCFAs MCFAs and BA after weight loss
Human study protocol
A pilot clinical trial in human study participants will be assayed Participants for intermittent fasting IF will be asked to fast for 24 hours on two days of the week 25 protocol
1A-Design Utilizing a randomized cross-over design study participants n15 will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet DCR or will undertake an intermittent IF protocol Each study period will be 8 weeks - total study period will be 16 weeks a 4-week washout period between dietary exposures The study participants will be adults who have obesity with a Body Mass Index BMI25 kgm2 and 40 kgm2 and have no contraindications for intermittent fasting see inclusion and exclusion criteria below
1 the dynamics of gastrointestinal hormones and energy sensing metabolites
2 the intestinal microbiome
3 variability on succinate and SCFAs MCFAs and BA after weight loss
Human study protocol
A pilot clinical trial in human study participants will be assayed Participants for intermittent fasting IF will be asked to fast for 24 hours on two days of the week 25 protocol
1A-Design Utilizing a randomized cross-over design study participants n15 will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet DCR or will undertake an intermittent IF protocol Each study period will be 8 weeks - total study period will be 16 weeks a 4-week washout period between dietary exposures The study participants will be adults who have obesity with a Body Mass Index BMI25 kgm2 and 40 kgm2 and have no contraindications for intermittent fasting see inclusion and exclusion criteria below
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