Time-restricted eating on metabolic control and circadian rhythm

Not Applicable

• Conditions: Obesity; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12623001311640
• Lead Sponsor: niversidad Juárez Autónoma de Tabasco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-15
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 30

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 .

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic and insulinemic responses. (Composite primary outcome).[ Timepoints: A day before and a day after each intervention periods. <br>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 Measures

Name	Time	Method
Circadian rhythm markers.(Composite secondary outcome)<br>Cortisol, BMAL1 (ARNTL), CLOCK, PER1 and PER2 genes will be measured in blood samples<br> [ One day before and one day after each intervention period.];Fasting metabolic biomarkers,(Composite secondary outcome). <br>Glycemia, insulin, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol. Glucagon-like peptide-1 (GLP-1) and peptide tyrosine tyrosine (PYY) in serum samples[ One day before and one day after the intervention period.];Body weight measured using digital scales[ One day before and one day after the intervention period.];Subjective appetite.estimated by an visual analogue scale [ 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.];Blood pressure measured using sphygmomanometer[ One day before and one day after the intervention period.]