Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05031572
Other study ID # PI20/00338
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2