Clinical trial

Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT06858683

Recruiting nowNot applicableInterventional

What this study is about

The goal of this randomized trial is to: 1) investigate the immunological landscape of patients with obesity and conduct an in-depth functional characterization of their immune system; and 2) precisely define the effects of time-restricted feeding (TRF) on immune function in patients with obesity; 3) define the immunomodulatory properties of white adipocytes in response to TRF, and 4) uncover the underlying mechanisms by which TRF modulates the immune system patients with obesity through a multi-omics approach. The main questions it aims to answer are: i) what is the underlying cause of impaired immunocompetence in patients with obesity? ii) how nutritional interventions improve the immune function of patients with obesity? Patients with obesity following TRF (8 h eating window ranging from 6-8 am to 14-16 pm) will be compared to patients with obesity without TRF control schedule (14h eating window ranging from 6-8 am to 8-10 pm). The dietary intervention will begin 10 weeks before the scheduled date for bariatric surgery in patients with obesity. In addition to patients with obesity, the present study aims to recruit a group of a reference healthy group (BMI between18.5-24.9 kg/m²) that will not receive any nutritional intervention. The following endpoints will be collected: Body weight and composition using Bioelectrical Impedance Analysis, resting energy expenditure (REE) using indirect calorimetry, blood glucose levels using a continuous glucose monitoring (CGM) device, metabolic parameters (fasting blood glucose levels, C-peptide, HbA1c, insulin, HOMA-IR, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, hepatic enzymes), and cytokine profile. Blood, stool, and white adipose tissue (WAT) samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years

SexFemale

Healthy volunteersAccepted

ConditionObesity and Obesity-related Medical Conditions

Full registry criteria

Inclusion Criteria: Patients with obesity * Women * Age 18-64 years * Body mass Index between 40-50 kg/m² * Scheduled bariatric surgery 10-12 weeks after the nutritional intervention * Self-reported eating pattern window of more than 14h * Three meal eating pattern * Stable body weight (less than 10% of current body weight during the last 3 months) * Patients who have a favorable decision from the multidisciplinary team meetings after multidisciplinary nutritional follow-up of at least 6 months and history of failure with non-surgical weight loss methods * Social security affiliation * Written consent * Good understanding of the Catalan or Spanish languages Exclusion Criteria: * Diabetes type I or II * Major cardiovascular disease * Pregnancy * Medication that could affect the study outcomes (i.e. anti-inflammatory drugs, antibiotics, immunosuppressors) * Use products intended for weight loss * Night work shift * Past record of malignant tumors * Serious liver dysfunction or chronic kidney disease * Eating disorders * Chronic viral disease (Hepatitis B or C, HIV) or inflammatory systemic diseases (i.e. Crohn's disease, rheumatoid arthritis) * Serious cardiovascular or cerebrovascular disease within 6 months before randomization * Severe gastrointestinal diseases or gastrointestinal surgery in the 12 months before randomization * Under guardianship, curatorship, deprived of liberty * Unable or unwilling to sign the informed consent form.

Treatments and study arms

Time-restrictred feeding

Other

Time-restricted feeding pattern consisting of an 8 h eating window (from 6-8 am to 14-16pm) followed by a 16 h fasting period.

Non-time restricted feeding

Other

14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.

Primary outcomes

Inflammatory cytokine IL-1β10 weeks

The mean difference in inflammatory cytokine IL-1β in patients with obesity after 10 weeks under TRF versus patients withobesity without TRF.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Vall Hebron Barcelona Hospital Campus🇪🇸 Barcelona, Spain

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Josep A. Villena DelgadoContact

Email · Call + 34 937372429

Ramón VilallongaPrincipal Investigator

Andreea CiudinPrincipal Investigator