Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964179
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2023-07-12
Brief Title:
Effects of Daily Eating Duration on Health
Sponsor:
Chung-Ang University
Organization:
Chung-Ang University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 feedingfasting 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 kgm2 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 gday 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 am and late type after 10 am 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
The subjects of this study are healthy adult women aged the 30s - 40s with a body mass index BMI of 23 kgm2 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 gday 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 am and late type after 10 am 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None