Healthy vs Unhealthy Obesity: Mehanistic Insights and Effects of Time-Restricted Eating

September 30, 2024 updated by: Mariana Cifuentes, Instituto de Nutrición y Tecnología de los Alimentos

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile, 7810000
        • INTA, Universidad de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MHO
metabolically healthy obese subjects undergoing TRE
Behavioral: Time-restricted eating
16 weeks of TRE consisting of an 8-hour eating window.
Other Names:
  • Intermittent fasting
  • Time-restricted feeding
Experimental: MUO
metabolically unhealthy obese subjects undergoing TRE
Behavioral: Time-restricted eating
16 weeks of TRE consisting of an 8-hour eating window.
Other Names:
  • Intermittent fasting
  • Time-restricted feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TG
Time Frame: 16 weeks
Fasting triglycerides
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Waist circumference
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Nutrición y Tecnología de los Alimentos

Collaborators

Universidad Católica del Maule
Agencia Nacional de Investigación y Desarrollo

Investigators

  • Principal Investigator: Mariana Cifuentes, PhD, Universidad de Chile INTA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2022

Primary Completion (Actual)

January 4, 2024

Study Completion (Actual)

January 4, 2024

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1211477

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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