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NCT05136313Completed

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

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

Source: ClinicalTrials.gov · Last updated 1 Oct 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
53 (actual)
First submitted
17 Nov 2021
Start date
24 Jun 2022
Primary completion date
4 Jan 2024
Lead sponsor
Instituto de Nutrición y Tecnología de los Alimentos
Diseases
Obesity
NCT number
NCT05136313

What you commit to

  • Study type: Interventional
  • Participants enrolled: 53
  • From 24 Jun 2022 to the primary completion date, 4 Jan 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Medications for any metabolic syndrome disorder
  • 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.

Other

  • Shift workers

Who the study is looking for

  • 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.

Age in the registry: 18 years to 25 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
INTA, Universidad de Chile
Coordinator of this site? Confirm its status
SantiagoChileUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.