Skip to main content
OpenTrials
Completed

NCT Number: NCT05136313

Healthy vs Unhealthy Obesity: Mehanistic 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

INTA, Universidad de Chile

Santiago, RM, 7810000, Chile

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Time-restricted eating

Behavioral

16 weeks of TRE consisting of an 8-hour eating window.

Other names: Time-restricted feeding, Intermittent fasting

Primary outcomes

  1. TG

    Time frame: 16 weeks

    Fasting triglycerides

Secondary outcomes

  1. Waist circumference

    Time frame: 16 weeks

Sponsors and collaborators

Lead sponsor

Instituto de Nutrición y Tecnología de los Alimentos

Other

Collaborators

  • Agencia Nacional de Investigación y Desarrollo
  • Universidad Católica del Maule

Registry information

Official study title

Healthy vs Unhealthy Obesity in Young Male Adults: Early Predictors, Mechanistic Insights and Effects of Time-Restricted Eating

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2021
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.