Energy -Sensing Metabolites in Caloric Restriction
New Energy-sensing Metabolites: Beneficial Effects on Metabolic Health in Obesity Comparing Diary Caloric Restriction vs Intermittent Fasting. A Randomized Cross-over Study
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
September 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 12, 2022
October 1, 2022
1.2 years
August 20, 2021
October 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (6)
1) the dynamics of gastrointestinal hormones and energy sensing metabolites
8 weeks - 20 weeks
2) Analysis of microbial species in fecal samples (gut flora)
8 weeks - 20 weeks
variability on succinate after weight loss
8 weeks - 20 weeks
variability on Short-chain fatty acids (SCFAs) after weight loss
8 weeks - 20 weeks
variability on Medium-chain fatty acids (MCFAs) after weight loss
8 weeks - 20 weeks
- +1 more secondary outcomes
Study Arms (2)
conventional caloric restriction diet
OTHER(DCR protocol): lifestyle recommendations for a healthy Mediterranean diet under a continued daily caloric restriction diet
Intermitent fasting
OTHERFasting for two days (non-consecutive) out of seven, with the fasting days separated by at least one day.
Interventions
Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitari Joan XXIII de Tarragona. IISPV
Tarragona, 43005, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joan J Vendrell, PhD
Director
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 20, 2021
First Posted
September 2, 2021
Study Start
August 1, 2021
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
Data sharing will be upon request directly to the PI