Energy -Sensing Metabolites in Caloric Restriction

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031572
• Other study ID #: PI20/00338
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Institut Investigacio Sanitaria Pere Virgili
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (n=15) 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.

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 (2/5 protocol). 1A.-Design: Utilizing a randomized, cross-over design, study participants (n=15) 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 (BMI)25 kg/m2 and 40 kg/m2 and have no contraindications for intermittent fasting (see inclusion and exclusion criteria below).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• White men and women between 18 and 65 years of age.
• BMI range between 25 and 40 kg/m2
• Absence of underlying pathology in medical and physical examination, except for those related to excess weight.
• Signature of the informed consent for participation in the study.

Exclusion Criteria:

• Serious systemic disease not related to obesity, such as cancer, kidney or severe liver disease.
• Systemic diseases with intrinsic inflammatory activity (autoimmune diseases such as rheumatoid arthritis and asthma)
• Pregnancy and lactation.
• Vegetarians or subjects subjected to an irregular diet.
• Patients with severe eating disorders.
• Patients with clinical symptoms and signs of infection in the previous month.
• Patients with chronic anti-inflammatory steroid treatments and/or nonsteroidal anti-inflammatory drugs.
• Recent antibiotic treatment.
• Psychiatric history.
• Uncontrolled alcoholism or drug abuse.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Insulin Resistance
• Insulin Sensitivity/Resistance
• Obesity

Intervention

Other:
• dietary intervention
Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis

Locations

Country	Name	City	State
Spain	Hospital Universitari Joan XXIII de Tarragona. IISPV	Tarragona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Investigacio Sanitaria Pere Virgili

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose)	Plasma concentrations of glucose during a meal test	basal and after 8 weeks
Primary	To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin)	Plasma concentrations of insulin during a meal test	basal and after 8 weeks
Primary	To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose after crossing arm)	Plasma concentrations of glucose during a meal test	at beginning of week 12 vs week 20
Primary	To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin after crossing arm)	Plasma concentrations of insulin during a meal test	at beginning of week 12 vs week 20
Secondary	1) the dynamics of gastrointestinal hormones and energy sensing metabolites	GLP-1; GLP-2 during a meal test	8 weeks - 20 weeks
Secondary	2) Analysis of microbial species in fecal samples (gut flora)	intestinal microbiome after each interventional period	8 weeks - 20 weeks
Secondary	variability on succinate after weight loss	quantification of succinate	8 weeks - 20 weeks
Secondary	variability on Short-chain fatty acids (SCFAs) after weight loss	quantification of SCFAs	8 weeks - 20 weeks
Secondary	variability on Medium-chain fatty acids (MCFAs) after weight loss	quantification of MACFAs	8 weeks - 20 weeks
Secondary	variability on biliary acids (BA) after weight loss	quantification of BA	8 weeks - 20 weeks