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.
age between 18 and 70 years old.
BMI ranges between 27 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.
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.
Parallel
Active Comparator: Continuous calorie restriction
BehavioralIndividualized 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
eTRE
Behavioralearly (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)
Anthropometric measurements (II)
Changes in body mass index (kg/m\^2);
Anthropometric measurements (III)
Changes waist circumference (cm)
Anthropometric measurements (IV)
Changes hip circumference (cm)
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)
Gut and host microbiota-derived metabolites (II)
Changes in circulating bile acids levels \[nM\]; Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Gut and host microbiota-derived metabolites (III)
Changes in circulating succinate levels \[µM\]; assesed by EnzyChrom™ Succinate Assay Kit
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
Click on the lead sponsor to view all of their trials.
