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

Vall d'Hebron University Hospital (HUVH)

Status: Enrolling

Conditions: Obesity and Obesity-related Medical Conditions

Treatments: Other: Time-restrictred feeding; Other: Non-time restricted feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT06858683

PR(AG)68/2023

Details and patient eligibility

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

Enrollment: 45 estimated patients

Sex: Female

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Time-restricted feeding

Experimental group

Description:

Women with grade 3 obesity (BMI 40-50 kg/m²) who are scheduled for bariatric surgery and follow a time-restricted feeding (TRF) pattern consisting of an 8 h eating window (from 6-8 am to 14-16 pm) followed by a 16 h fasting period.

Treatment:

Other: Time-restrictred feeding

Non-Time restricted feeding

Experimental group

Description:

Women with grade 3 obesity (BMI 40-50 kg/m²) who are scheduled for bariatric surgery and follow a 14h eating window (from 6-8 am to 8-10pm), followed by a 10 h fasting period.

Treatment:

Other: Non-time restricted feeding

Control

No Intervention group

Description:

Women with a healthy body weight without any dietary intervention.