NCT05964179

Brief Summary

This study would recruit about 50 healthy adult women and randomly divide the participants into two groups for a ten-week crossover intervention study. The investigators aimed to observe the impact of daily feeding/fasting time on clinical metabolic biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

July 12, 2023

Last Update Submit

December 20, 2023

Conditions

Body Weight MaintenanceNutritional and Metabolic Diseases

Outcome Measures

Primary Outcomes (3)

  • change of body weight in kilogram before and after the intervention

    Direct measurement

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

  • change of body fat in kilogram before and after the intervention

    Direct measurement

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

  • change of waist circumference in centimeter before and after the intervention

    Direct measurement

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

Secondary Outcomes (4)

  • change of fasting blood glucose (mg/dL)

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

  • change of serum TG (mg/dL)

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

  • change of serum HDL-C (mg/dL)

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

  • change of serum TC(mg/dL)

    before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

Study Arms (2)

time restricted feeding

EXPERIMENTAL

total feeding time (from the first meal or snack to the last) is assigned as 8 hours/day.

Behavioral: time extended feeding

time extended feeding

EXPERIMENTAL

total feeding time (from the first meal or snack to the last) is assigned as 14 hours/day.

Behavioral: time restricted feeding

Interventions

time extended feedingBEHAVIORAL

Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 14 hours per day.

time restricted feeding
time restricted feedingBEHAVIORAL

Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 8 hours per day.

time extended feeding

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult women with a body mass index (BMI) of 23 kg/m2 or a body fat rate of 28% or higher

You may not qualify if:

  • whose eating patterns have not been consistent over the past three months who has changed his or her weight in the past three months by more than 5% who has been diagnosed with cardiovascular disease/cancer/diabetes/hypertension or who has taken drugs for related diseases be pregnant or breast-feeding within the last three months who drink too much (alcohol intake ≥ 10 g/day, about 300cc of beer, about 1 glass of soju) who smoke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuang-Ang University

Anseong, Gyeonggi-do, 17546, South Korea

Location

Related Publications (1)

  • Tan LJ, Shin S. Impact of eating duration on weight management, sleeping quality, and psychological stress: A pilot study. J Nutr Biochem. 2025 Mar;137:109835. doi: 10.1016/j.jnutbio.2024.109835. Epub 2024 Dec 17.

    PMID: 39701471DERIVED

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Study Officials

  • Sangah Shin, Ph.D

    Chung-Ang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

July 12, 2023

First Posted

July 27, 2023

Study Start

March 8, 2023

Primary Completion

November 2, 2023

Study Completion

November 16, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Locations

KR(1)