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

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: Recruiting
• Conditions: Intermittent Fasting; Metabolically Healthy Obesity
• Intervention / Treatment: Behavioral: Time-restricted eating

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 (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana Cifuentes, PhD; Phone Number: 56229781428; Email: mcifuentes@inta.uchile.cl

Study Locations

• Chile
  • RM
    • Santiago, RM, Chile, 7810000
      • Recruiting
      • INTA, Universidad de Chile
      • Contact: Mariana Cifuentes, PhD; Phone Number: 562229781428; Email: mcifuentes@inta.uchile.cl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

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

How is the study designed?

Design Details

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

Number of Arms

2

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	Fasting triglycerides	16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Waist circumference	16 weeks

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): April 1, 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 (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Adipokines; Metabolic health; Time restricted eating; PBMC
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Metabolically Benign
• 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