Body Weight MaintenanceNCT05964179
Effects of Daily Eating Duration on Health
A study testing time extended feeding and time restricted feeding in people with Body Weight Maintenance and Nutritional and Metabolic Diseases, run by Chung-Ang University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Body Weight Maintenance, Nutritional and Metabolic Diseases
- What is being tested?
- time extended feeding and time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Mar 2023to 16 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult women with a body mass index (BMI) of 23 kg/m2 or a body fat rate of 28% or higher
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of Chrononutrition Factors Associated With Chronic Non-communicable Diseases and Investigation of Circadian Gene-Chrononutrition Interactions in the Development of Chronic Non-communicable Diseases Among Koreans
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.
Read the detailed description
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.
- Being tested
- time extended feeding, time restricted feeding
- Medical subject headings
- Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
time extended feedingBehavioural
Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 14 hours per day.
time restricted feedingBehavioural
Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 8 hours per day.
| Study group | Role | What they receive |
|---|---|---|
| time restricted feeding | Experimental | total feeding time (from the first meal or snack to the last) is assigned as 8 hours/day. Receives: 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. Receives: Behavioral: time restricted feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of body weight in kilogram before and after the intervention
Direct measurement
Measured: 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
Measured: 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
Measured: 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)
Direct measurement
Measured: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
change of serum TG (mg/dL)
Direct measurement
Measured: 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)
Direct measurement
Measured: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
change of serum TC(mg/dL)
Direct measurement
Measured: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start8 Mar 2023
- Primary completion2 Nov 2023
- Study completion16 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Weight MaintenanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung-Ang University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Sangah Shin, Chung-Ang University
- Investigators
- Sangah Shin, Ph.D, Principal investigator, Chung-Ang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964179
- Sponsor's protocol ID
- 1041078-20230217-BR-035
- Status last verified
- Dec 2023
- First submitted
- 12 Jul 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39701471
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Chrononutrition Factors Associated With Chronic Non-communicable Diseases and Investigation of Circadian Gene-Chrononutrition Interactions in the Development of Chronic Non-communicable Diseases Among Koreans
- ClinicalTrials.gov ID
- NCT05964179
- Acronym / sponsor ID
- 1041078-20230217-BR-035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Chung-Ang UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 16 Nov 2023 (actual)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| time restricted feeding | Experimental | Behavioral: time extended feedingtotal feeding time (from the first meal or snack to the last) is assigned as 8 hours/day. |
| time extended feeding | Experimental | Behavioral: time restricted feedingtotal feeding time (from the first meal or snack to the last) is assigned as 14 hours/day. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy adult women with a body mass index (BMI) of 23 kg/m2 or a body fat rate of 28% or higher
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| time extended feedingTotal feeding time (from the first meal or snack to the last meal or snack) is assigned as 14 hours per day. | Behavioural | time restricted feeding |
| time restricted feedingTotal feeding time (from the first meal or snack to the last meal or snack) is assigned as 8 hours per day. | Behavioural | time extended feeding |
Primary outcome
change of body weight in kilogram before and after the intervention
Time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Direct measurement
change of body fat in kilogram before and after the intervention
Time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Direct measurement
change of waist circumference in centimeter before and after the intervention
Time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Direct measurement
4 secondary outcomes
change of fasting blood glucose (mg/dL)
Time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
change of serum TG (mg/dL)
Time frame: 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)
Time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
change of serum TC(mg/dL)
Time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Derived from this study: PubMed 39701471Tan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangah Shin, Ph.D principal investigator
Chung-Ang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing time extended feeding and time restricted feeding in people with Body Weight Maintenance and Nutritional and Metabolic Diseases, run by Chung-Ang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of body weight in kilogram before and after the intervention (time frame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05964179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2023.