Metabolically Healthy ObesityNCT05136313
Healthy vs Unhealthy Obesity: Mehanistic Insights and Effects of Time-Restricted Eating
A study testing Time-restricted eating in people with Metabolically Healthy Obesity and Intermittent Fasting, run by Instituto de Nutrición y Tecnología de los Alimentos at 1 site in Chile.
Trial summary
Obesity-related cardiometabolic diseases are now a leading cause of death worldwide. These diseases result from a dysfunctional adipose tissue (AT) that induces inflammation, insulin resistance and altered endocrine function. Read more about this study
- Who is it for?
- Ages 18 to 25 years, men only
- Conditions the study is for
- Metabolically Healthy Obesity, Intermittent Fasting
- What is being tested?
- Time-restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChile
- Study dates
- 24 Jun 2022to 4 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Belong to the GOCS cohort at INTA
- BMI≥30
- Own and use a Smartphone with Apple iOS or Android OS
- Baseline eating period ≥ 13 h per day.
Who cannot join
- Medications for any metabolic syndrome disorder
- Shift workers
- Known inflammatory and/or rheumatologic disease
- History of cardiovascular event
- Thyroid or adrenal disease, malignancy or diabetes
- History of eating disorder.
- Special diet (e.g., celiac disease),or any other disease or treatment that may interfere with the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy vs Unhealthy Obesity in Young Male Adults: Early Predictors, Mechanistic Insights and Effects of Time-Restricted Eating
Obesity-related cardiometabolic diseases are now a leading cause of death worldwide. These diseases result from a dysfunctional adipose tissue (AT) that induces inflammation, insulin resistance and altered endocrine function. However, not all obese people develop metabolic complications, which has given rise to the concept of "metabolically healthy obesity" (MHO). Recent evidence suggests that intermittent fasting methods, in particular time-restricted eating (TRE) may be effective in improving cardiometabolic health, independently of weight loss, and this could be particularly effective in MUO subjects. The investigators hypothesize that in young male adults TRE is a more effective/beneficial approach in MUO than in MHO due to the weight loss-independent improvement in their inflammatory and metabolic derangements. To this aim, a 16-week 8h TRE intervention study will be performed in MHO and MUO subjects, assessing anthropometric, endocrine, and other outcomes.
Read the detailed description
Although clinical differences between metabolically healthy and unhealthy obesity (MHO and MUO, respectively) have been extensively described, cellular mechanisms involved in these different phenotypes are largely unknown. This evidence is crucial for proposing preventive and therapeutic approaches. Recently, intermittent fasting methods, in particular time-restricted eating (TRE, a self-selected daily limited eating window protocol), have shown to be effective in improving cardiometabolic health, independently of weight loss, which could be particularly relevant in MUO.
The investigators will recruit young (20-22y-old) males with obesity (Body Mass Index≥30) and classify them as MHO or MUO (≤1 or ≥3 metabolic syndrome risk factors, respectively). A 16-week, 8h TRE intervention will be conducted in MHO vs. MUO subgroups, to assess and compare the anthropometric, metabolic, endocrine, inflammatory and peripheral blood mononuclear cell (PBMC) mechanistic/signaling response.
The investigators expect to advance the understanding of cellular mechanisms implicated in MHO and MUO, including potential therapeutic targets. Ultimately, the investigators expect to find relevant opportunities for intervention to prevent the serious cardiometabolic consequences of obesity.
- Being tested
- Time-restricted eating
- Keywords
- Time restricted eating, Metabolic health, PBMC, Adipokines
- Medical subject headings
- Obesity, Metabolically Benign, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eatingBehavioural
Also called Time-restricted feeding, Intermittent fasting
16 weeks of TRE consisting of an 8-hour eating window.
| Study group | Role | What they receive |
|---|---|---|
| MHO | Experimental | metabolically healthy obese subjects undergoing TRE Receives: Behavioral: Time-restricted eating |
| MUO | Experimental | metabolically unhealthy obese subjects undergoing TRE Receives: Behavioral: Time-restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
TG
Fasting triglycerides
Measured: 16 weeks
Secondary outcomes (1)
Waist circumference
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2021
- Study start24 Jun 2022
- Primary completion4 Jan 2024
- Study completion4 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolically Healthy ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- TRE intervention comparing MHO vs MUO
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Nutrición y Tecnología de los Alimentos
- Sponsor type
- University, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo, Universidad Católica del Maule
- Responsible party
- Principal investigator, Mariana Cifuentes, Instituto de Nutrición y Tecnología de los Alimentos
- Investigators
- Mariana Cifuentes, PhD, Principal investigator, Universidad de Chile INTA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136313
- Sponsor's protocol ID
- 1211477
- Status last verified
- Sep 2024
- First submitted
- 17 Nov 2021
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy vs Unhealthy Obesity in Young Male Adults: Early Predictors, Mechanistic Insights and Effects of Time-Restricted Eating
- ClinicalTrials.gov ID
- NCT05136313
- Acronym / sponsor ID
- 1211477
- Keywords
- Time restricted eating, Metabolic health, PBMC, Adipokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Instituto de Nutrición y Tecnología de los AlimentosUniversity, hospital or other
- Collaborators
- Agencia Nacional de Investigación y Desarrollo, Universidad Católica del Maule
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 4 Jan 2024 (actual)
- Study completion
- 4 Jan 2024 (actual)
- First posted
- 29 Nov 2021 (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.
Obesity-related cardiometabolic diseases are now a leading cause of death worldwide. These diseases result from a dysfunctional adipose tissue (AT) that induces inflammation, insulin resistance and altered endocrine function. However, not all obese people develop metabolic complications, which has given rise to the concept of "metabolically healthy obesity" (MHO). Recent evidence suggests that intermittent fasting methods, in particular time-restricted eating (TRE) may be effective in improving cardiometabolic health, independently of weight loss, and this could be particularly effective in MUO subjects. The investigators hypothesize that in young male adults TRE is a more effective/beneficial approach in MUO than in MHO due to the weight loss-independent improvement in their inflammatory and metabolic derangements. To this aim, a 16-week 8h TRE intervention study will be performed in MHO and MUO subjects, assessing anthropometric, endocrine, and other outcomes.
Detailed description
Although clinical differences between metabolically healthy and unhealthy obesity (MHO and MUO, respectively) have been extensively described, cellular mechanisms involved in these different phenotypes are largely unknown. This evidence is crucial for proposing preventive and therapeutic approaches. Recently, intermittent fasting methods, in particular time-restricted eating (TRE, a self-selected daily limited eating window protocol), have shown to be effective in improving cardiometabolic health, independently of weight loss, which could be particularly relevant in MUO.
The investigators will recruit young (20-22y-old) males with obesity (Body Mass Index≥30) and classify them as MHO or MUO (≤1 or ≥3 metabolic syndrome risk factors, respectively). A 16-week, 8h TRE intervention will be conducted in MHO vs. MUO subgroups, to assess and compare the anthropometric, metabolic, endocrine, inflammatory and peripheral blood mononuclear cell (PBMC) mechanistic/signaling response.
The investigators expect to advance the understanding of cellular mechanisms implicated in MHO and MUO, including potential therapeutic targets. Ultimately, the investigators expect to find relevant opportunities for intervention to prevent the serious cardiometabolic consequences of obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- TRE intervention comparing MHO vs MUO
| Arm | Type | Receives |
|---|---|---|
| MHO | Experimental | Behavioral: Time-restricted eatingmetabolically healthy obese subjects undergoing TRE |
| MUO | Experimental | Behavioral: Time-restricted eatingmetabolically unhealthy obese subjects undergoing TRE |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Belong to the GOCS cohort at INTA
- BMI≥30
- Own and use a Smartphone with Apple iOS or Android OS
- Baseline eating period ≥ 13 h per day.
Key exclusion criteria (7 listed)
- Medications for any metabolic syndrome disorder
- Shift workers
- Known inflammatory and/or rheumatologic disease
- History of cardiovascular event
- Thyroid or adrenal disease, malignancy or diabetes
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-restricted eatingAlso: Time-restricted feeding, Intermittent fasting16 weeks of TRE consisting of an 8-hour eating window. | Behavioural | MHO, MUO |
Primary outcome
TG
Time frame: 16 weeks
Fasting triglycerides
1 secondary outcome
Waist circumference
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mariana Cifuentes, PhD principal investigator
Universidad de Chile INTA
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-restricted eating in people with Metabolically Healthy Obesity and Intermittent Fasting, run by Instituto de Nutrición y Tecnología de los Alimentos at 1 site in Chile.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 1 Oct 2024. 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 Chile. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TG (time frame: 16 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 1 Oct 2024.