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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

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
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05136313