Clinical trial NCT05964179: 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
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Maintenance
Nutritional and Metabolic Diseases
Lead sponsor: Chung-Ang University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2023-07-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: change of body weight in kilogram before and after the intervention
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
measure: change of body fat in kilogram before and after the intervention
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
measure: change of waist circumference in centimeter before and after the intervention
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Secondary outcomes:
measure: change of fasting blood glucose (mg/dL)
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
measure: change of serum TG (mg/dL)
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
measure: change of serum HDL-C (mg/dL)
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
measure: change of serum TC(mg/dL)
timeFrame: before and after the two intervention periods (first intervention (baseline, week 4), second intervention ( week 7, week 10))
Other outcomes:
Locations:
city: Anseong
country: Korea, Republic of
facility: Chuang-Ang University
state: Gyeonggi-do
Study officials:
affiliation: Chung-Ang University
name: Sangah Shin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: