NCT07062315

Brief Summary

Time-restricted eating (TRE) has gained attention as a promising dietary strategy for enhancing body composition and metabolic health. This innovative eating pattern involves confining daily food intake to a specific window, typically spanning 6-10 hours. Given the lack of consensus on the optimal TRE strategy, this research explores whether tailoring eating windows to individual chronotypes enhances TRE outcomes. This randomized controlled trial aims to evaluate the effects of chronotype-matched versus chronotype-unmatched TRE protocols, compared to a control group, over a 12-week period on visceral fat mass and other metabolic health outcomes in physically inactive adults with central obesity. Additionally, the study seeks to determine whether chronotype-matched TRE offers greater benefits in terms of visceral fat reduction and metabolic improvements compared to chronotype-unmatched TRE. Assessments will be conducted at baseline, and after the 12-week intervention.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

June 24, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

July 31, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

June 24, 2025

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visceral fat mass

    Visceral fat mass will be assessed using Magnetic Resonance Imaging (MRI)

    12 weeks

Secondary Outcomes (12)

  • Subcutaneous fat mass

    12 weeks

  • Body weight

    12 weeks

  • Body mass index (BMI)

    12 weeks

  • Body composition (Fat mass, fat free mass)

    12 weeks

  • Anthropometric measures

    12 weeks

  • +7 more secondary outcomes

Other Outcomes (2)

  • Objectively physical activity levels

    12 weeks

  • Chronotype

    12 weeks

Study Arms (3)

Chronotype-matched TRE

EXPERIMENTAL

Participants will eat ad libitum within an 8-hour eating window that match their chronotype.

Behavioral: Chronotype-matched time-restricted eating

Chronotype-unmatched TRE

ACTIVE COMPARATOR

Participants will eat ad libitum within an 8-hour eating window that unmatch their chronotype.

Behavioral: Chronotype-unmatched time-restricted eating

Waitlist control

NO INTERVENTION

Participants in the waitlist control group will be instructed to maintain their previous eating or physical activity habits during the 12-week intervention. They will not receive any specific dietary advice or guidance. Weekly check-ins will be conducted to confirm continued participation and adherence. If they wish to participate, we will provide a suitable intervention after the duration of the study period.

Interventions

A 12 weeks time-restricted eating intervention that match participants' chronotype

Chronotype-matched TRE

A 12 weeks time-restricted eating intervention that not match participants' chronotype

Chronotype-unmatched TRE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese adults, male or female, aged between 18-65 years old;
  • BMI of 23 kg/m² or higher, with a waist circumference exceeding 80 cm for females and 90 cm for males;
  • Weight stability for at least three months prior to the start of the study;
  • Physically inactive, indicated by not meeting established WHO guidelines on physical activity and sedentary behavior (i.e., at least 150-300 minutes of moderate-intensity or at least 75-150 minutes of vigorous-intensity aerobic exercise; or an equivalent combination of moderate and vigorous-intensity activity throughout the week;
  • Baseline eating duration exceeding 12 hours per day;
  • Identified as either early or late chronotypes (Morningness-Eveningness Questionnaire)

You may not qualify if:

  • Individuals currently or chronically receiving pharmacological treatment for hypertension, diabetes, weight loss, or other metabolic conditions;
  • Night shift workers;
  • Individuals with eating disorders;
  • Female participants who are breast-feeding, pregnant, or attempting to become pregnant;
  • Individuals currently participating in other weight-management programs or following other prescribed diet programs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Science and Physical Education, The Chinese University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Obesity, AbdominalIntermittent Fasting

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFastingFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 24, 2025

First Posted

July 14, 2025

Study Start

July 31, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations