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The main aim of the present study is to evaluate the effectiveness of two dietary protocols: Daily Caloric Restriction (DCR) and Early Time-Restricted Feeding + DCR (eTRE) on metabolic homeostasis and the influence of circulating extracellular vesicles (EVs) as inter-organ communication elements in obese patients.
The specific objectives are:
The study design comprises a randomized parallel-arm design (n=40) with consecutive 1:1 allocation to a calorie restriction protocol for a healthy Mediterranean diet under Daily Caloric Restriction (DCR) (n=20) or an eTRE protocol (n=20) for 12 weeks. Clinical and analytical variables, adherence, satiety, chronotype, and brown fat content will be determined before and at the end of the follow-up. Derivatives of intestinal microbiota, short-chain fatty acids, bile acids, and circulating metabolites derived from host intermediary metabolism will be assessed through metabolomics. Glucagon-like peptide 1 (GLP1) and gastric inhibitory polypeptide (GIP) dynamics after a standard meal test. Metagenomics. Bioenergetic analysis of PBMC by SeaHorse. Total EV miRNA profile. Isolation of host and bacterial EVs. Characterization of the protein cargo of host and bacterial EVs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous caloric restriction | Active Comparator | Continuous calorie restriction diet based on healthy Mediterranean diet recommendations |
|
| eTRE | Experimental | early (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Comparator: Continuous calorie restriction | Behavioral | Individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometric measurements (I) | Changes in weight (kg) | Before and after (12 weeks) of the intervention |
| Anthropometric measurements (II) | Changes in body mass index (kg/m^2); | Before and after (12 weeks) of the intervention |
| Anthropometric measurements (III) | Changes waist circumference (cm) | Before and after (12 weeks) of the intervention |
| Anthropometric measurements (IV) | Changes hip circumference (cm) | Before and after (12 weeks) of the intervention |
| Anthropometric measurements (V) | Changes neck circumference (cm) | Before and after (12 weeks) of the intervention |
| Body composition (I) | Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®) | Before and after (12 weeks) of the intervention |
| Body composition (II) | Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®) | Before and after (12 weeks) of the intervention |
| Body composition (III) | Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®) |
| Measure | Description | Time Frame |
|---|---|---|
| Gut and host microbiota-derived metabolites (I) | Changes in circulating short-chain fatty acids levels [µM]; assesed by Gas Chromatography-Tandem Mass Spectrometry (GC-MS/MS) | Before and after (12 weeks) of the intervention |
| Gut and host microbiota-derived metabolites (II) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan José Vendrell Ortega, Professor | Contact | +34 619672912 | jvortega2002@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Juan José Vendrell Ortega, Professor | Instituto de Investigación Sanitaria Pere Virgili (IISPV) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Tarragona Juan XXIII | Recruiting | Tarragona | Tarragona | 43005 | Spain |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Randomized parallel-arm design (n=40) with consecutive 1:1 allocation to either a continuous calorie restriction diet (n=20) for a healthy Mediterranean diet or an early time-restricted eating protocol + continuous caloric restriction (n=20) over 12 weeks.
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triple-blind: participants, intervention researchers - except for the nutritionist in charge of diet and lifestyle counseling - and data analysts will be blinded.
| eTRE | Behavioral | early (morning) time-restricted eating pluss individualized continuous calorie restriction diet based on healthy Mediterranean diet recommendations aiming to achieve at least a 5% weight loss at the end of the intervention |
|
| Before and after (12 weeks) of the intervention |
| Brown fat | Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI) | Before and after (12 weeks) of the intervention |
Changes in circulating bile acids levels [nM]; Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) |
| Before and after (12 weeks) of the intervention |
| Gut and host microbiota-derived metabolites (III) | Changes in circulating succinate levels [µM]; assesed by EnzyChrom™ Succinate Assay Kit | Before and after (12 weeks) of the intervention |
| Entero-endocrine incretin hormones (I) | Changes in post-prandial response to a meal-tolerance test in serum levels of glucose [mg/dL]; assesed by ELISA kit | Before and after (12 weeks) of the intervention |
| Entero-endocrine incretin hormones (II) | Changes in post-prandial response to a meal-tolerance test in serum levels of insulin levels [pmol/L] ]assesed by ELISA kit | Before and after (12 weeks) of the intervention |
| Entero-endocrine incretin hormones (III) | Changes in post-prandial response to a meal-tolerance test in plasma levels of glucagon-like peptite 1 [GLP-1 ] (pmol/L); assesed by ELISA kit | Before and after (12 weeks) of the intervention |
| Entero-endocrine incretin hormones (IV) | Changes in post-prandial response to a meal-tolerance test in plasma levels of gastric inhibitory polypeptide (GIP) [pg/mL]; assesed by ELISA kit | Before and after (12 weeks) of the intervention |
| Microbial composition/metagenomic | Changes in alpha and beta diversity, relative abundance and functional metagenomics; assesed by Ilumina metagenomics | Before and after (12 weeks) of the intervention |
| Cellular energy metabolism | Changes in Cluster of Differentiation 14 positive (CD14+) monocytes isolated from peripheral blood mononuclear cells (PBMCs) will be used for bioenergetics analysis via an extracellular flux analyzer | Before and after (12 weeks) of the intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |