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Trial registered on ANZCTR


Registration number
ACTRN12623001311640
Ethics application status
Approved
Date submitted
17/01/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Time-restricted eating on metabolic control and circadian rhythm
Scientific title
Effects of early time-restricted eating on metabolic control and circadian rhythm markers in subjects with obesity
Secondary ID [1] 308230 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 327989 0
Condition category
Condition code
Metabolic and Endocrine 325049 325049 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In a randomised, controlled, and crossover design, thirty participants will be randomised into one of the two intervention phases: control arm or early time-restricted eating (eTRE) arm for four weeks. Each phase will be separated by six weeks washout period. The eTRE arm will consist of an 8-hour feeding window (07:00 to 15:00) and 16-hour of fasting period. Meanwhile, the control arm will consist of a 12-hour feeding window (07:00 to 19:00) and 12-hour of fasting period. Participants will log in a food diary the food and the start and stop time of every meal eaten two weeks before the first phase of intervention and during each intervention phase. Before and after each intervention phase and during a 4-hour visit to the study clinic, the following parameters will be determined: body weight, waist/hip circumference, biochemical parameters, and blood pressure by a healthcare provider. Meal Tolerance Test (MTT) will be performed for glycaemic and insulinemic response and subjective appetite. The standardized breakfast for the MTT, will consist of a commercial standardized liquid meal and a Kellog’s® Rice Krispies® bar both providing 210 calories, 79% carbohydrates, 14% protein and 7% fat. To assess patient's adherence subjects will be regularly monitored by WhatsApp and phone calls..
Intervention code [1] 324690 0
Lifestyle
Comparator / control treatment
Control arm: unrestricted feeding mimicking the typical daily feeding window of 12-hour.
Control group
Active

Outcomes
Primary outcome [1] 332938 0
Glycemic and insulinemic responses. (Composite primary outcome).
Timepoint [1] 332938 0
Timepoints: A day before and a day after each intervention periods.
The glycemic and insulinemic responses will be determined during a Meal Tolerance Test (MTT). Blood samples will be taken at 0, 15, 30, 60, 90, 120, 150, and 180 minutes after consuming a standardized breakfast.
Secondary outcome [1] 415228 0
Circadian rhythm markers.(Composite secondary outcome)
Cortisol, BMAL1 (ARNTL), CLOCK, PER1 and PER2 genes will be measured in blood samples
Timepoint [1] 415228 0
One day before and one day after each intervention period.
Secondary outcome [2] 415230 0
Fasting metabolic biomarkers,(Composite secondary outcome).
Glycemia, insulin, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol. Glucagon-like peptide-1 (GLP-1) and peptide tyrosine tyrosine (PYY) in serum samples
Timepoint [2] 415230 0
One day before and one day after the intervention period.
Secondary outcome [3] 415231 0
Body weight measured using digital scales
Timepoint [3] 415231 0
One day before and one day after the intervention period.
Secondary outcome [4] 416690 0
Subjective appetite.estimated by an visual analogue scale
Timepoint [4] 416690 0
Two minutes before of the time points of MTT (0, 15, 30, 60, 90, 120, 150, and 180 minutes). MTT will occur twice : one day and one day after the intervention period.
Secondary outcome [5] 427958 0
Blood pressure measured using sphygmomanometer
Timepoint [5] 427958 0
One day before and one day after the intervention period.

Eligibility
Key inclusion criteria
1. Aged 18-59. Both men and women.
2. Body Mass Index (BMI) >30 kg/m2.
3. Have maintained stable weight during three months prior to intervention.
4. Regular menstrual cycle (for women).
5. Independently provide informed consent .
Minimum age
18 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of diabetes, cardiovascular, kidney, liver, gastrointestinal, psychiatric or endocrine disease.
2. Pregnant or breast-feeding females.
3. Have diagnostic of sleeping disorders.
4. History of gastrointestinal surgery.
5. Nightshift work more than once a week.
6. Consumption of corticosterois and ß-blockers.
7. Fasting regularly more than 15 hours/day.
8. Nicotine or tobacco consumption.
9. Alcohol consumption.
10. Regular participation in sports training or intense physical activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using https://www.random.org/
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a difference of 10% in the primary outcome variable of glycemia 180 min AUC with a power > 0.8 and a type I error of 5% in a crossover design a group of 30 subjects were estimated. Time-course data will be analyzed by repeated measures (RM) two-way analysis of variance (ANOVA) to assess the effects of treatment, time, and the interaction of treatment and time. RM one-way ANOVA or Student’s t-tests will be used to compare the effects of treatments on fasting parameters. The D’Agostino-Pearson normality test will be performed to assess whether the data are consistent with a Gaussian distribution. Differences will be considered statistically significant at p < 0.05. Data will be processed and analyzed using the GraphPad Prism Software version 9.0 (San Diego, CA, USA). The sample size calculation was performed using the PASS 21.0 (Kaysville, Utah, USA) software.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 25088 0
Mexico
State/province [1] 25088 0
Tabasco

Funding & Sponsors
Funding source category [1] 312530 0
University
Name [1] 312530 0
Universidad Juárez Autónoma de Tabasco
Country [1] 312530 0
Mexico
Primary sponsor type
University
Name
Universidad Juárez Autónoma de Tabasco
Address
Av. Universidad S/NZona de la CulturaColonia Magisterial C.P. 86040Villahermosa, Centro, Tabasco
Country
Mexico
Secondary sponsor category [1] 314129 0
None
Name [1] 314129 0
Address [1] 314129 0
Country [1] 314129 0
Other collaborator category [1] 282478 0
Hospital
Name [1] 282478 0
Hospital General de Zona 46, Instituto Mexicano del Seguro Social
Address [1] 282478 0
Avenida Universidad s/n, Casa Blanca Segunda Seccion, C.P. 86060 Villahermosa, Tab.
Country [1] 282478 0
Mexico

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311825 0
Comisión Institucional de Ética en Investigación (CIEI)
Ethics committee address [1] 311825 0
Ethics committee country [1] 311825 0
Mexico
Date submitted for ethics approval [1] 311825 0
07/10/2022
Approval date [1] 311825 0
26/10/2022
Ethics approval number [1] 311825 0
CIEI-1184

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122502 0
Dr Jorge Luis Ble Castillo
Address 122502 0
Centro de InvestigaciónDivisión Académica de Ciencias de la SaludUniversidad Juárez Autónoma de TabascoAvenida Gregorio Méndez 2838-AColonia TamultéVillahermosa, Tabasco, MéxicoC.P. 86150
Country 122502 0
Mexico
Phone 122502 0
+52 1 9931735353
Fax 122502 0
Email 122502 0
jblecastillo@hotmail.com
Contact person for public queries
Name 122503 0
Guadalupe Jiménez Domínguez
Address 122503 0
Hospital General de Zona No. 46Instituto Mexicano del Seguro SocialAv. Universidad S/NColonia Casa Blanca, C.P. 86060Villahermosa, Tabasco
Country 122503 0
Mexico
Phone 122503 0
+52 1 9933115716
Fax 122503 0
Email 122503 0
jimenezg03@hotmail.com
Contact person for scientific queries
Name 122504 0
Jorge Luis Ble Castillo
Address 122504 0
Centro de InvestigaciónDivisión Académica de Ciencias de la SaludUniversidad Juárez Autónoma de TabascoAvenida Gregorio Méndez 2838-AColonia TamultéVillahermosa, Tabasco, MéxicoC.P. 86150
Country 122504 0
Mexico
Phone 122504 0
+52 1 9931735353
Fax 122504 0
Email 122504 0
jblecastillo@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17554Ethical approval    384861-(Uploaded-09-11-2022-06-59-40)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.