Obesity and Obesity-related Medical ConditionsOBESIMMNCT06858683
Study of the Effects of Time-Restricted Feeding on the Immune Function of Individuals With Obesity
A study testing Time-restrictred feeding and Non-time restricted feeding in people with Obesity and Obesity-related Medical Conditions, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- Time-restrictred feeding and Non-time restricted feeding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 21 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Vall Hebron Barcelona Hospital Campus
Barcelona, 08035
Josep A. Villena Delgado, + 34 937372429, josep.villena@vhir.org
Ramón Vilallonga
About this study
Official title: Exploring the Effects of Time-Restricted Feeding on the Immune Function of Obese Individuals: A Multi-Omic Approach
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.
Read more
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
- Being tested
- Time-restrictred feeding, Non-time restricted feeding
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restrictred feedingOther
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 feedingOther
14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Time-restrictred feeding |
| 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. Receives: Other: Non-time restricted feeding |
| Control | No intervention | Women with a healthy body weight without any dietary intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (17)
Percent of weight change from baseline
Measured: Baseline, 10 weeks
Change in body composition (lean and fat mass) from baseline
Measured: Baseline, 10 weeks
Change in resting energy expenditure from baseline
Measured: Baseline, 10 weeks
Change in fasting blood glucose levels from baseline
Measured: Baseline, 10 weeks
Change in fasting C-peptide from baseline
Measured: Baseline, 10 weeks
Change in HbA1c from baseline
Measured: Baseline, 10 weeks
Change in fasting insulin levels from baseline
Measured: Baseline, 10 weeks
Change in HOMA-IR from baseline
Measured: Baseline, 10 weeks
Change in lipid profile from baseline
Baseline, 10 weeks
Measured: Baseline, 10 weeks
Change in hepatic enzymes from baseline
Measured: Baseline, 10 weeks
Change in cytokine profile from baseline
Measured: Baseline, 10 weeks
Changes in blood metabolome
Measured: Baseline, 10 weeks
Changes in gut microbiome
Measured: Baseline, 10 weeks
Changes in adipose tissue metabolome
Measured: Baseline, 10 weeks
Changes in gene expression profile
Measured: Baseline, 10 weeks
Changes in blood immune cell populations
Measured: Baseline, 10 weeks
Changes in adipose tissue immune cell populations
Measured: Baseline, 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start21 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858683
- Sponsor's protocol ID
- PR(AG)68/2023
- Acronym
- OBESIMM
- Status last verified
- Jun 2025
- First submitted
- 27 Feb 2025
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in theprotocol of a planned metaanalysis could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Effects of Time-Restricted Feeding on the Immune Function of Obese Individuals: A Multi-Omic Approach
- ClinicalTrials.gov ID
- NCT06858683
- Acronym / sponsor ID
- OBESIMM / PR(AG)68/2023
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Time-restricted feeding | Experimental | Other: Time-restrictred feedingWomen 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 | Other: Non-time restricted feedingWomen 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restrictred feedingTime-restricted feeding pattern consisting of an 8 h eating window (from 6-8 am to 14-16pm) followed by a 16 h fasting period. | Other | Time-restricted feeding |
| Non-time restricted feeding14h eating window (from 6-8 am to 8-10 pm), followed by a 10 h fasting period. | Other | Non-Time restricted feeding |
Primary outcome
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.
17 secondary outcomes
Percent of weight change from baseline
Time frame: Baseline, 10 weeks
Change in body composition (lean and fat mass) from baseline
Time frame: Baseline, 10 weeks
Change in resting energy expenditure from baseline
Time frame: Baseline, 10 weeks
Change in fasting blood glucose levels from baseline
Time frame: Baseline, 10 weeks
Change in fasting C-peptide from baseline
Time frame: Baseline, 10 weeks
Change in HbA1c from baseline
Time frame: Baseline, 10 weeks
Change in fasting insulin levels from baseline
Time frame: Baseline, 10 weeks
Change in HOMA-IR from baseline
Time frame: Baseline, 10 weeks
Change in lipid profile from baseline
Time frame: Baseline, 10 weeks
Change in hepatic enzymes from baseline
Time frame: Baseline, 10 weeks
Change in cytokine profile from baseline
Time frame: Baseline, 10 weeks
Changes in blood metabolome
Time frame: Baseline, 10 weeks
Changes in gut microbiome
Time frame: Baseline, 10 weeks
Changes in adipose tissue metabolome
Time frame: Baseline, 10 weeks
Changes in gene expression profile
Time frame: Baseline, 10 weeks
Changes in blood immune cell populations
Time frame: Baseline, 10 weeks
Changes in adipose tissue immune cell populations
Time frame: Baseline, 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in theprotocol of a planned metaanalysis could be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restrictred feeding and Non-time restricted feeding in people with Obesity and Obesity-related Medical Conditions, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josep A. Villena Delgado (+ 34 937372429, josep.villena@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory cytokine IL-1β (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.