An interventional study of Active Comparator: Continuous calorie restriction and eTRE in Obesity, sponsored by Institut Investigacio Sanitaria Pere Virgili. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Institut Investigacio Sanitaria Pere Virgili · Not applicable, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 35 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Continuous calorie restriction diet based on healthy Mediterranean diet recommendations
Behavioral: Active Comparator: Continuous calorie restriction
early (morning) time-restricted eating (eTRE) plus continuous caloric restriction diet based on healthy Mediterranean diet recommendations
Behavioral: eTRE
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
Anthropometric 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
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
Plan to share: No
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Institut Investigacio Sanitaria Pere Virgili