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

NCT05136313 | Completed

• 1 other identifier: 1211477
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Metabolically Healthy Obesity; Intermittent Fasting

Keywords

Time restricted eating; Metabolic health; PBMC; Adipokines

Outcome Measures

Primary Outcomes (1)

• TG

  Fasting triglycerides

  16 weeks

Secondary Outcomes (1)

• Waist circumference

  16 weeks

Study Arms (2)

MHO

EXPERIMENTAL

metabolically healthy obese subjects undergoing TRE

Behavioral: Time-restricted eating

MUO

EXPERIMENTAL

metabolically unhealthy obese subjects undergoing TRE

Behavioral: Time-restricted eating

Interventions

Time-restricted eating BEHAVIORAL

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

Also known as: Time-restricted feeding, Intermittent fasting

MHO; MUO

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Nutrición y Tecnología de los Alimentos: lead
• Agencia Nacional de Investigación y Desarrollo: collaborator
• Universidad Católica del Maule: collaborator

Study Sites (1)

INTA, Universidad de Chile

Santiago, RM, 7810000, Chile

Location

MeSH Terms

Conditions

Obesity, Metabolically Benign; Intermittent Fasting

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fasting; Feeding Behavior; Behavior

Study Officials

• Mariana Cifuentes, PhD

  Universidad de Chile INTA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: TRE intervention comparing MHO vs MUO

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 29, 2021
• Study Start: June 24, 2022
• Primary Completion: January 4, 2024
• Study Completion: January 4, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CL (1)