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: 1. To assess the effect of two dietary protocols on weight loss and metabolic benefits in non-morbidly obese subjects. 2. Influence of both protocols on energy signaling metabolites and the dynamics of enteroendocrine hormones. 3. Define the "digital footprint" of EVs as inter-organ communication elements influencing metabolic status in obese subjects. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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
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
Hospital Universitario de Tarragona Juan XXIII
Tarragona, Tarragona, Spain
RECRUITINGAnthropometric measurements (I)
Changes in weight (kg)
Time frame: Before and after (12 weeks) of the intervention
Anthropometric measurements (II)
Changes in body mass index (kg/m\^2);
Time frame: Before and after (12 weeks) of the intervention
Anthropometric measurements (III)
Changes waist circumference (cm)
Time frame: Before and after (12 weeks) of the intervention
Anthropometric measurements (IV)
Changes hip circumference (cm)
Time frame: Before and after (12 weeks) of the intervention
Anthropometric measurements (V)
Changes neck circumference (cm)
Time frame: Before and after (12 weeks) of the intervention
Body composition (I)
Changes in fat body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Time frame: Before and after (12 weeks) of the intervention
Body composition (II)
Changes in lean body mass (kg); assesed by bioimpedance monitoring device (Seca®)
Time frame: Before and after (12 weeks) of the intervention
Body composition (III)
Changes visceral adipose tissue (L); assesed by bioimpedance monitoring device (Seca®)
Time frame: Before and after (12 weeks) of the intervention
Brown fat
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Changes in brown fat volume (cm3); assessed by magnetic resonance image (MRI)
Time frame: Before and after (12 weeks) of the intervention
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)
Time frame: Before and after (12 weeks) of the intervention
Gut and host microbiota-derived metabolites (II)
Changes in circulating bile acids levels \[nM\]; Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before and after (12 weeks) of the intervention