Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05136313
Other study ID # 1211477
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 24, 2022
Est. completion date April 2024

Study information

Verified date March 2023
Source Instituto de Nutrición y Tecnología de los Alimentos
Contact Mariana Cifuentes, PhD
Phone 56229781428
Email mcifuentes@inta.uchile.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 2024
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 25 Years
Eligibility 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 Design


Intervention

Behavioral:
Time-restricted eating
16 weeks of TRE consisting of an 8-hour eating window.

Locations

Country Name City State
Chile INTA, Universidad de Chile Santiago RM

Sponsors (3)

Lead Sponsor Collaborator
Instituto de Nutrición y Tecnología de los Alimentos Agencia Nacional de Investigación y Desarrollo, Universidad Católica del Maule

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary TG Fasting triglycerides 16 weeks
Secondary Waist circumference 16 weeks
See also
  Status Clinical Trial Phase
Completed NCT04647149 - Effects of Early and Delayed Time-restricted Eating in Adults With Overweight and Obesity N/A
Completed NCT04953650 - Intermittent Fasting Towards Elevated Blood Pressure N/A
Active, not recruiting NCT05290233 - Time Restricted Eating Plus Exercise for Weight Management N/A
Completed NCT04404413 - High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women N/A
Recruiting NCT05558423 - ZOE Health Study: The Intermittent Fasting Study N/A
Completed NCT02770313 - Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction N/A
Active, not recruiting NCT05344066 - Manchester Intermittent Diet in Gestational Diabetes Acceptability Study N/A
Not yet recruiting NCT06330610 - Evaluation of the Efficiency of Intermittent Enteral Nutrition on Multi-organ Failure From Patients With Mechanical Ventilation in Intensive Care Unit N/A
Not yet recruiting NCT06299020 - Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency N/A
Recruiting NCT03789409 - Intermittent Fasting Following Acute Ischemic Stroke N/A
Not yet recruiting NCT06302231 - Effects of Time-restricted Eating and Aerobic Exercise Training in Women With Overweight and Obesity N/A
Recruiting NCT05760339 - Intermittent Fasting Versus Carbohydrate Drinks Before Surgery N/A
Recruiting NCT06429124 - Time Restricted Eating in Alzheimer's Disease (TREAD) N/A
Enrolling by invitation NCT06105372 - Ramadan Fasting, Microbiota and FABP4
Completed NCT04732130 - Monitoring During Different Intermittent Fasting Protocols in Non-Obese Adults N/A
Completed NCT05422391 - The Acute Effects of Caloric Restriction on Anthropometrics, Metabolism, and Cardiovascular Health in Overweight Adults N/A
Not yet recruiting NCT06323889 - Longitudinal Monitoring During Intermittent Fasting Protocols in Obese Adults N/A
Completed NCT01378208 - How Often Should We Eat N/A
Recruiting NCT04873648 - Effect of Fasting and Calorie-Restricted Diets on Dopamine and Serotonin Levels Among Obese Women With BED and FA N/A
Recruiting NCT06174259 - Influence of Intermittent Fasting on Locally Advanced Breast Cancer Patients N/A