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NCT Number: NCT06858683

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

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

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vall Hebron Barcelona Hospital Campus

Barcelona, 08035, Spain

Location status: Recruiting

Location contact

Andreea Ciudin

PRINCIPAL_INVESTIGATOR

Josep A. Villena Delgado

CONTACT

[email protected]

+ 34 937372429

Ramón Vilallonga

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Inflammatory cytokine IL-1β

    Time frame: 10 weeks

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

Secondary outcomes

  1. Percent of weight change from baseline

    Time frame: Baseline, 10 weeks

  2. Change in body composition (lean and fat mass) from baseline

    Time frame: Baseline, 10 weeks

  3. Change in resting energy expenditure from baseline

    Time frame: Baseline, 10 weeks

  4. Change in fasting blood glucose levels from baseline

    Time frame: Baseline, 10 weeks

  5. Change in fasting C-peptide from baseline

    Time frame: Baseline, 10 weeks

  6. Change in HbA1c from baseline

    Time frame: Baseline, 10 weeks

  7. Change in fasting insulin levels from baseline

    Time frame: Baseline, 10 weeks

  8. Change in HOMA-IR from baseline

    Time frame: Baseline, 10 weeks

  9. Change in lipid profile from baseline

    Time frame: Baseline, 10 weeks

    Baseline, 10 weeks

  10. Change in hepatic enzymes from baseline

    Time frame: Baseline, 10 weeks

  11. Change in cytokine profile from baseline

    Time frame: Baseline, 10 weeks

  12. Changes in blood metabolome

    Time frame: Baseline, 10 weeks

  13. Changes in gut microbiome

    Time frame: Baseline, 10 weeks

  14. Changes in adipose tissue metabolome

    Time frame: Baseline, 10 weeks

  15. Changes in gene expression profile

    Time frame: Baseline, 10 weeks

  16. Changes in blood immune cell populations

    Time frame: Baseline, 10 weeks

  17. Changes in adipose tissue immune cell populations

    Time frame: Baseline, 10 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Josep A. Villena Delgado

CONTACT

[email protected]

+ 34 937372429

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Exploring the Effects of Time-Restricted Feeding on the Immune Function of Obese Individuals: A Multi-Omic Approach

Acronym: OBESIMM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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