Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
FEMALE
Healthy Volunteers
NCT06858683

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

Led by Hospital Universitari Vall d'Hebron Research Institute · Updated on 2025-06-08

45

Participants Needed

1

Research Sites

92 weeks

Total Duration

On this page

AI-Summary

What this Trial 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 64Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with obesity
  • Age between 18 and 64 years
  • Body mass index between 40 and 50 kg/m²
  • Scheduled bariatric surgery 10 to 12 weeks after starting the nutritional intervention
  • Self-reported eating window longer than 14 hours per day
  • Three meals per day
  • Stable body weight (less than 10% change in last 3 months)
  • Favorable decision from multidisciplinary team after at least 6 months of nutritional follow-up and failure of non-surgical weight loss methods
  • Social security affiliation
  • Written informed consent
  • Good understanding of Catalan or Spanish languages
Not Eligible

You will not qualify if you...

  • Type 1 or type 2 diabetes
  • Major cardiovascular disease
  • Pregnancy
  • Use of medications affecting study outcomes (anti-inflammatory drugs, antibiotics, immunosuppressors)
  • Use of weight loss products
  • Night shift work
  • History of malignant tumors
  • Serious liver dysfunction or chronic kidney disease
  • Eating disorders
  • Chronic viral infections (Hepatitis B or C, HIV) or systemic inflammatory diseases (Crohn's disease, rheumatoid arthritis)
  • Serious cardiovascular or cerebrovascular disease within 6 months before randomization
  • Severe gastrointestinal diseases or surgery within 12 months before randomization
  • Under guardianship, curatorship, or deprived of liberty
  • Unable or unwilling to provide informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Vall Hebron Barcelona Hospital Campus

Barcelona, Spain, 08035

Actively Recruiting

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Research Team

J

Josep A. Villena Delgado

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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