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Effects of Daily Eating Duration on Health

NCT ID: NCT05964179

Last Updated: 2023-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-08

Study Completion Date

2023-11-16

Brief Summary

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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.

Detailed Description

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Many nutritional epidemiological studies conducted among various population groups (Cohort study, RCT study) found that chrono-nutrition factors such as morning fasting, functional supplements like fish oils, intermittent fasting, and time-restricted feeding were related to weight management, cardiovascular metabolism, blood glucose, and blood lipid metabolism. Some dietary intervention studies have found its effect on weight loss, sleep improvement, blood glucose improvement, insulin sensitivity, β cell reactivity, blood pressure, oxidative stress, and appetite improvement. This intervention study aims to investigate changes in chronic disease risk factors according to the daily meal exposure time (from the first meal to the last meal or snack) in healthy adult women.

The subjects of this study are healthy adult women aged the 30s - 40s with a body mass index (BMI) of 23 kg/m2 or a body fat rate of 28% or higher and would be excluded if the participants have inconsistent eating patterns or weight changes of 5% or more over the past three months, are pregnant or breastfeeding, are heavy drinkers (alcohol intake of 10 g/day, 300 cc), and are smokers.

A total of 10 weeks of intervention are conducted. Two meal exposure time groups are performed for four weeks each, and there is a two-week wash-out between different exposure times. The total meal period per day would be limited to 8 hours ± 30 minutes for the TRF group, and 14 hours ± 30 minutes for the EXF group. Each group will be divided into early type (before 10 a.m.) and late type (after 10 a.m.) depending on the participants' first meal timing and will be changed to another group in the second intervention period. During the 10-week study, blood (to collect genetic information related to blood lipids, blood sugar, 10ml) and urine (to collect metabolic indicators such as urine sodium, 15ml) samples would be collected four times.

Changes in evaluation variables (body composition indicators, urine indicators, or blood indicators) before and after each intervention period will be tested using the paired t-test. The association between meal time and changes in biomarkers will be tested by ANOVA using a mixed model. The analysis would be adjusted for covariates related to lifestyle (sleeping time, physical activity level, smoking status) and chrono-nutrition-related genetic information.

Conditions

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Body Weight Maintenance Nutritional and Metabolic Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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time restricted feeding

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

Group Type EXPERIMENTAL

time extended feeding

Intervention Type BEHAVIORAL

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

time extended feeding

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

Group Type EXPERIMENTAL

time restricted feeding

Intervention Type BEHAVIORAL

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

Interventions

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time extended feeding

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

Intervention Type BEHAVIORAL

time restricted feeding

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Research Foundation of Korea

OTHER

Sponsor Role collaborator

Chung-Ang University

OTHER

Sponsor Role lead

Responsible Party

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Sangah Shin

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sangah Shin, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Chung-Ang University

Locations

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Chuang-Ang University

Anseong, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 39701471 (View on PubMed)

Other Identifiers

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1041078-20230217-BR-035

Identifier Type: -

Identifier Source: org_study_id