Effects of Daily Eating Duration on Health

Nutritional and Metabolic Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05964179
• Other study ID #: 1041078-20230217-BR-035
• Status: Completed
• Phase: N/A
• Start date: March 8, 2023
• Est. completion date: November 16, 2023

Study information

• Verified date: December 2023
• Source: Chung-Ang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 16, 2023
• Est. primary completion date: November 2, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Metabolic Diseases
• Nutritional and Metabolic Diseases

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Chuang-Ang University	Anseong	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Chung-Ang University	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))
Primary	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))
Primary	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	change of fasting blood glucose (mg/dL)	Direct measurement	before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Secondary	change of serum TG (mg/dL)	Direct measurement	before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Secondary	change of serum HDL-C (mg/dL)	Direct measurement	before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Secondary	change of serum TC(mg/dL)	Direct measurement	before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))