Diabetes Type 2, Insulin Sensitivity/Resistance, Obesity
Conditions
Keywords
obesity, diabetes, intermittent fasting, energy-sensing metabolites
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).
Interventions
OTHERdietary intervention
Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis
Sponsors
Institut Investigacio Sanitaria Pere Virgili
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
clinical study: randomized, cross-over design, study participants will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of glucose) | basal and after 8 weeks | Plasma concentrations of glucose during a meal test |
| To investigate whether IF is better than DCR in terms of metabolic improvement through the study (change in the secretory pattern of insulin) | basal and after 8 weeks | Plasma concentrations of insulin during a meal test |
| 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) | at beginning of week 12 vs week 20 | Plasma concentrations of glucose during a meal test |
| 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) | at beginning of week 12 vs week 20 | Plasma concentrations of insulin during a meal test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| variability on Medium-chain fatty acids (MCFAs) after weight loss | 8 weeks - 20 weeks | quantification of MACFAs |
| 2) Analysis of microbial species in fecal samples (gut flora) | 8 weeks - 20 weeks | intestinal microbiome after each interventional period |
| variability on biliary acids (BA) after weight loss | 8 weeks - 20 weeks | quantification of BA |
| 1) the dynamics of gastrointestinal hormones and energy sensing metabolites | 8 weeks - 20 weeks | GLP-1; GLP-2 during a meal test |
| variability on succinate after weight loss | 8 weeks - 20 weeks | quantification of succinate |
| variability on Short-chain fatty acids (SCFAs) after weight loss | 8 weeks - 20 weeks | quantification of SCFAs |
Countries
Spain
Outcome results
None listed