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

Primary Purpose

Metabolically Healthy Obesity, Intermittent Fasting

Status
Recruiting
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Time-restricted eating
Sponsored by
Instituto de Nutrición y Tecnología de los Alimentos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolically Healthy Obesity focused on measuring Time restricted eating, Metabolic health, PBMC, Adipokines

Eligibility Criteria

18 Years - 25 Years (Adult)MaleDoes not accept healthy volunteers

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.

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Exclusion Criteria: medications for any metabolic syndrome disorder, shift workers, known inflammatory and/or rheumatologic disease, history of cardiovascular event, thyroid or adrenal disease, history of malignancy, diabetes, eating disorder, special diet (e.g., celiac disease),or any other disease or treatment that may interfere with the study.

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Sites / Locations

  • INTA, Universidad de ChileRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MHO

MUO

Arm Description

metabolically healthy obese subjects undergoing TRE

metabolically unhealthy obese subjects undergoing TRE

Outcomes

Primary Outcome Measures

TG
Fasting triglycerides

Secondary Outcome Measures

Waist circumference

Full Information

First Posted
November 17, 2021
Last Updated
March 2, 2023
Sponsor
Instituto de Nutrición y Tecnología de los Alimentos
Collaborators
Agencia Nacional de Investigación y Desarrollo, Universidad Católica del Maule
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1. Study Identification

Unique Protocol Identification Number
NCT05136313
Brief Title
Healthy vs Unhealthy Obesity: Mehanistic Insights and Effects of Time-Restricted Eating
Official Title
Healthy vs Unhealthy Obesity in Young Male Adults: Early Predictors, Mechanistic Insights and Effects of Time-Restricted Eating
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Nutrición y Tecnología de los Alimentos
Collaborators
Agencia Nacional de Investigación y Desarrollo, Universidad Católica del Maule

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolically Healthy Obesity, Intermittent Fasting
Keywords
Time restricted eating, Metabolic health, PBMC, Adipokines

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
TRE intervention comparing MHO vs MUO
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MHO
Arm Type
Experimental
Arm Description
metabolically healthy obese subjects undergoing TRE
Arm Title
MUO
Arm Type
Experimental
Arm Description
metabolically unhealthy obese subjects undergoing TRE
Intervention Type
Behavioral
Intervention Name(s)
Time-restricted eating
Other Intervention Name(s)
Time-restricted feeding, Intermittent fasting
Intervention Description
16 weeks of TRE consisting of an 8-hour eating window.
Primary Outcome Measure Information:
Title
TG
Description
Fasting triglycerides
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Waist circumference
Time Frame
16 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariana Cifuentes, PhD
Phone
56229781428
Email
mcifuentes@inta.uchile.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana Cifuentes, PhD
Organizational Affiliation
Universidad de Chile INTA
Official's Role
Principal Investigator
Facility Information:
Facility Name
INTA, Universidad de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
7810000
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariana Cifuentes, PhD
Phone
562229781428
Email
mcifuentes@inta.uchile.cl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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