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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-restricted feeding | Experimental | 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. |
|
| Non-Time restricted feeding | Experimental | 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. |
|
| Control | No Intervention | Women with a healthy body weight without any dietary intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory cytokine IL-1β | The mean difference in inflammatory cytokine IL-1β in patients with obesity after 10 weeks under TRF versus patients withobesity without TRF. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of weight change from baseline | Baseline, 10 weeks | |
| Change in body composition (lean and fat mass) from baseline | Baseline, 10 weeks | |
| Change in resting energy expenditure from baseline |
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Inclusion Criteria:
Patients with obesity
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep A. Villena Delgado | Contact | + 34 937372429 | josep.villena@vhir.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vall Hebron Barcelona Hospital Campus | Recruiting | Barcelona | 08035 | Spain |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in theprotocol of a planned metaanalysis could be shared.
Two years after the last publication.
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with EuropeanGeneral Data Protection Regulation (GDPR).
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Investigator aim to recruit a group of patients with obesity to test the effect of TRF on immune function and a group of patients with normal weight as a reference group.
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| Non-time restricted feeding | Other | 14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period. |
|
| Baseline, 10 weeks |
| Change in fasting blood glucose levels from baseline | Baseline, 10 weeks |
| Change in fasting C-peptide from baseline | Baseline, 10 weeks |
| Change in HbA1c from baseline | Baseline, 10 weeks |
| Change in fasting insulin levels from baseline | Baseline, 10 weeks |
| Change in HOMA-IR from baseline | Baseline, 10 weeks |
| Change in lipid profile from baseline | Baseline, 10 weeks | Baseline, 10 weeks |
| Change in hepatic enzymes from baseline | Baseline, 10 weeks |
| Change in cytokine profile from baseline | Baseline, 10 weeks |
| Changes in blood metabolome | Baseline, 10 weeks |
| Changes in gut microbiome | Baseline, 10 weeks |
| Changes in adipose tissue metabolome | Baseline, 10 weeks |
| Changes in gene expression profile | Baseline, 10 weeks |
| Changes in blood immune cell populations | Baseline, 10 weeks |
| Changes in adipose tissue immune cell populations | Baseline, 10 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |