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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05136313




Registration number
NCT05136313
Ethics application status
Date submitted
17/11/2021
Date registered
29/11/2021
Date last updated
1/10/2024

Titles & IDs
Public title
Healthy vs Unhealthy Obesity: Mehanistic Insights and Effects of Time-Restricted Eating
Scientific title
Healthy vs Unhealthy Obesity in Young Male Adults: Early Predictors, Mechanistic Insights and Effects of Time-Restricted Eating
Secondary ID [1] 0 0
1211477
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolically Healthy Obesity 0 0
Intermittent Fasting 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Time-restricted eating

Experimental: MHO - metabolically healthy obese subjects undergoing TRE

Experimental: MUO - metabolically unhealthy obese subjects undergoing TRE


BEHAVIORAL: Time-restricted eating
16 weeks of TRE consisting of an 8-hour eating window.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TG
Timepoint [1] 0 0
16 weeks
Secondary outcome [1] 0 0
Waist circumference
Timepoint [1] 0 0
16 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
25 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/01/2024
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Chile
State/province [1] 0 0
RM

Funding & Sponsors
Primary sponsor type
Other
Name
Instituto de Nutrición y Tecnología de los Alimentos
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Agencia Nacional de Investigación y Desarrollo
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Universidad Católica del Maule
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05136313
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Mariana Cifuentes, PhD
Address 0 0
Universidad de Chile INTA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05136313