Energy -Sensing Metabolites in Caloric Restriction

NCT ID: NCT05031572

Last Updated: 2022-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-10-01

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 (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.

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 (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).

Conditions

Obesity; Insulin Sensitivity/Resistance; Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional caloric restriction diet

(DCR protocol): lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet

Group Type: OTHER

dietary intervention

Intervention Type: OTHER

Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis

Intermitent fasting

Fasting for two days (non-consecutive) out of seven, with the fasting days separated by at least one day.

Group Type: OTHER

dietary intervention

Intervention Type: OTHER

Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis

Interventions

dietary intervention

Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Investigacio Sanitaria Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Joan Josep Vendrell

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan J Vendrell, PhD

Role: STUDY_DIRECTOR

Director

Locations

Hospital Universitari Joan XXIII de Tarragona. IISPV

Tarragona, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

PI20/00338

Identifier Type: -

Identifier Source: org_study_id