Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420466
Status:
COMPLETED
Last Update Posted:
2024-05-20
First Post:
2024-05-04
Brief Title:
Time-Restricted Feeding on Cardiovascular Health Effects
Sponsor:
Zhengqi Qiu
Organization:
Macau University of Science and Technology Hospital
Study Overview
Official Title:
Dietary Intake Status and Time-Restricted Feeding on Cardiovascular Health Effects in the Overweight Population A Study of Students at a Shenzhen University
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Study Design and Participants This intervention study was conducted as a randomized controlled trial RCT aimed at investigating the effects of time-restricted feeding TRF on cardiovascular health markers among overweight male university students in Shenzhen China The study recruited male university students aged between 18 and 24 years with a Body Mass Index BMI ranging from 24 to less than 28 All participants were free from severe psychiatric illnesses metabolic syndrome diabetes alcoholic fatty liver disease hyperthyroidism or hypothyroidism Inclusion criteria required participants to be non-smokers not currently on any diet pills and have no history of cardiovascular or metabolic diseases
Randomization and Intervention Fifty eligible participants were randomly assigned to either the intervention group n25 or the control group n25 The intervention group underwent a 6-hour daily TRF from noon to 6 PM while the control group did not participate in TRF but maintained their usual eating patterns No restrictions were placed on the type or quantity of food consumed by participants in either group
Data Collection and Measures Body Composition and Anthropometry Measurements included body mass index body fat percentage muscle mass hydration levels protein content and visceral fat all assessed using a bioelectrical impedance analysis scale Mi Body Composition Scale 2 by Huami Technology Waist circumference was manually measured by experienced nurses using a tape measure
Blood Pressure and Heart Rate These vital signs were monitored using an arm cuff electronic blood pressure monitor Panasonic EW3153 with the arm positioned at heart level to ensure accuracy Measurements were taken after at least five minutes of seated rest
Nutritional Intake Although time-restricted feeding interventions do not usually change the content or quantity of dietary intake the total daily intakes of energy fat protein carbohydrate cholesterol and fibre were calculated using the Nutritionist Pro food analysis program This was used to determine possible changes in the subjects dietary composition as a result of the intervention
Compliance and Ethical Considerations The study protocol was approved by the Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University Shenzhen with the approval number KY-2022-101-01 All data were handled confidentially and measures were taken to ensure high adherence and minimal loss to follow-up
Statistical Analysis Descriptive statistics such as range mean standard deviation and percentages were used to describe the sample characteristics To compare differences the change from baseline levels was assessed to account for initial variability employing an independent samples t-test for the analysis
Randomization and Intervention Fifty eligible participants were randomly assigned to either the intervention group n25 or the control group n25 The intervention group underwent a 6-hour daily TRF from noon to 6 PM while the control group did not participate in TRF but maintained their usual eating patterns No restrictions were placed on the type or quantity of food consumed by participants in either group
Data Collection and Measures Body Composition and Anthropometry Measurements included body mass index body fat percentage muscle mass hydration levels protein content and visceral fat all assessed using a bioelectrical impedance analysis scale Mi Body Composition Scale 2 by Huami Technology Waist circumference was manually measured by experienced nurses using a tape measure
Blood Pressure and Heart Rate These vital signs were monitored using an arm cuff electronic blood pressure monitor Panasonic EW3153 with the arm positioned at heart level to ensure accuracy Measurements were taken after at least five minutes of seated rest
Nutritional Intake Although time-restricted feeding interventions do not usually change the content or quantity of dietary intake the total daily intakes of energy fat protein carbohydrate cholesterol and fibre were calculated using the Nutritionist Pro food analysis program This was used to determine possible changes in the subjects dietary composition as a result of the intervention
Compliance and Ethical Considerations The study protocol was approved by the Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University Shenzhen with the approval number KY-2022-101-01 All data were handled confidentially and measures were taken to ensure high adherence and minimal loss to follow-up
Statistical Analysis Descriptive statistics such as range mean standard deviation and percentages were used to describe the sample characteristics To compare differences the change from baseline levels was assessed to account for initial variability employing an independent samples t-test for the analysis
Detailed Description:
None
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