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Completed

NCT Number: NCT05031572

Energy -Sensing Metabolites in Caloric Restriction

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.

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Key information

Conditions

Obesity Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Fasting Feeding Behavior Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity/Resistance Intermittent Fasting Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Joan XXIII de Tarragona. IISPV

Tarragona, 43005, Spain

About this study

To investigate whether IF is better than DCR in terms of metabolic improvement through the study of:

  • the dynamics of gastrointestinal hormones and energy sensing metabolites
  • the intestinal microbiome
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary Intervention

Other

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

Primary outcomes

  1. To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose)

    Time frame: basal and after 8 weeks

    Plasma concentrations of glucose during a meal test

  2. To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin)

    Time frame: basal and after 8 weeks

    Plasma concentrations of insulin during a meal test

  3. 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)

    Time frame: at beginning of week 12 vs week 20

    Plasma concentrations of glucose during a meal test

  4. 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)

    Time frame: at beginning of week 12 vs week 20

    Plasma concentrations of insulin during a meal test

Secondary outcomes

  1. 1) the dynamics of gastrointestinal hormones and energy sensing metabolites

    Time frame: 8 weeks - 20 weeks

    GLP-1; GLP-2 during a meal test

  2. 2) Analysis of microbial species in fecal samples (gut flora)

    Time frame: 8 weeks - 20 weeks

    intestinal microbiome after each interventional period

  3. variability on succinate after weight loss

    Time frame: 8 weeks - 20 weeks

    quantification of succinate

  4. variability on Short-chain fatty acids (SCFAs) after weight loss

    Time frame: 8 weeks - 20 weeks

    quantification of SCFAs

  5. variability on Medium-chain fatty acids (MCFAs) after weight loss

    Time frame: 8 weeks - 20 weeks

    quantification of MACFAs

  6. variability on biliary acids (BA) after weight loss

    Time frame: 8 weeks - 20 weeks

    quantification of BA

Sponsors and collaborators

Lead sponsor

Institut Investigacio Sanitaria Pere Virgili

Other

Registry information

Official study title

New Energy-sensing Metabolites: Beneficial Effects on Metabolic Health in Obesity Comparing Diary Caloric Restriction vs Intermittent Fasting. A Randomized Cross-over Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 2, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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