search
Back to results

Effects of Daily Eating Duration on Health

Primary Purpose

Body Weight Maintenance, Nutritional and Metabolic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
time extended feeding
time restricted feeding
Sponsored by
Chung-Ang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Body Weight Maintenance

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chuang-Ang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

time restricted feeding

time extended feeding

Arm Description

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

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

Outcomes

Primary Outcome Measures

change of body weight in kilogram before and after the intervention
Direct measurement
change of body fat in kilogram before and after the intervention
Direct measurement
change of waist circumference in centimeter before and after the intervention
Direct measurement

Secondary Outcome Measures

change of fasting blood glucose (mg/dL)
Direct measurement
change of serum TG (mg/dL)
Direct measurement
change of serum HDL-C (mg/dL)
Direct measurement
change of serum TC(mg/dL)
Direct measurement

Full Information

First Posted
July 12, 2023
Last Updated
July 19, 2023
Sponsor
Chung-Ang University
Collaborators
National Research Foundation of Korea
search

1. Study Identification

Unique Protocol Identification Number
NCT05964179
Brief Title
Effects of Daily Eating Duration on Health
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung-Ang University
Collaborators
National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Weight Maintenance, Nutritional and Metabolic Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
time restricted feeding
Arm Type
Experimental
Arm Description
total feeding time (from the first meal or snack to the last) is assigned as 8 hours/day.
Arm Title
time extended feeding
Arm Type
Experimental
Arm Description
total feeding time (from the first meal or snack to the last) is assigned as 14 hours/day.
Intervention Type
Behavioral
Intervention Name(s)
time extended feeding
Intervention Description
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
Intervention Name(s)
time restricted feeding
Intervention Description
Total feeding time (from the first meal or snack to the last meal or snack) is assigned as 8 hours per day.
Primary Outcome Measure Information:
Title
change of body weight in kilogram before and after the intervention
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Title
change of body fat in kilogram before and after the intervention
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Title
change of waist circumference in centimeter before and after the intervention
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Secondary Outcome Measure Information:
Title
change of fasting blood glucose (mg/dL)
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Title
change of serum TG (mg/dL)
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Title
change of serum HDL-C (mg/dL)
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Title
change of serum TC(mg/dL)
Description
Direct measurement
Time Frame
before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sangah Shin, Ph.D
Phone
+82-31-670-3259
Email
ivory8320@cau.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Lijuan Tan, Ph.D
Phone
+82-31-670-3259
Email
tanlijuan@cau.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangah Shin, Ph.D
Organizational Affiliation
Chung-Ang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chuang-Ang University
City
Anseong
State/Province
Gyeonggi-do
ZIP/Postal Code
17546
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sangah Shin, Ph.D
Phone
+82-31-670-3259
Email
ivory8320@cau.ac.kr

12. IPD Sharing Statement

Learn more about this trial

Effects of Daily Eating Duration on Health

We'll reach out to this number within 24 hrs