Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-27 @ 7:05 AM
Study NCT ID:
NCT05756868
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2022-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
Sponsor:
Eastern Mediterranean University
Organization:
Study Overview
Official Title:
The Effect of Time-Restricted Feeding Intervention on Anthropometric Measurements, Biochemical Parameters, Diet Quality and Eating Behavior in Overweight Female Individuals
Status:
COMPLETED
Status Verified Date:
2023-02
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:
The goal of this randomized controlled trial is to to determine the effects of time-restricted feeding intervention on body weight, body composition, biochemical parameters and eating behaviors in overweight female individuals.
The main questions it aims to answer are:
1. Does time-restricted feeding intervention reduce daily energy intake?
2. Does time-restricted dietary intervention result in body weight and body fat loss?
3. Does time-limited nutritional intervention lead to improvements in biochemical parameters?
4. Does time-restricted feeding intervention improve eating behavior and eating awareness?
5. Does time-restricted feeding intervention adversely affect diet quality?
The participants in the intervention group will receive a time restricted feeding intervention (first meal at 10:00, last meal at 18:00) for 6 weeks. Meals of the participants are planned as 8 hours of eating and 16 hours of fasting.
Participants in the control group will not receive any dietary intervention.
The main questions it aims to answer are:
1. Does time-restricted feeding intervention reduce daily energy intake?
2. Does time-restricted dietary intervention result in body weight and body fat loss?
3. Does time-limited nutritional intervention lead to improvements in biochemical parameters?
4. Does time-restricted feeding intervention improve eating behavior and eating awareness?
5. Does time-restricted feeding intervention adversely affect diet quality?
The participants in the intervention group will receive a time restricted feeding intervention (first meal at 10:00, last meal at 18:00) for 6 weeks. Meals of the participants are planned as 8 hours of eating and 16 hours of fasting.
Participants in the control group will not receive any dietary intervention.
Detailed Description:
Following the ethics committee approval, the study will be carried out with the participants who applied to the Famagusta State Hospital Internal Medicine Polyclinic, Specialist Umut Hakligil.
In order to start the study, TR Ministry of Health Nicosia Dr. Necessary permissions were obtained from the Ethics Committee of Burhan Nalbantoğlu State Hospital.
The study is planned to be conducted with 40 female participants, who were not diagnosed with any disease by the physician, aged 19-65, slightly obese, with a BMI of 24.9-29.9 kg/m².
Before being included in the research, participants will be informed about the purpose of the research and the applications to be made during the research.
This information was supported with the valid consent form.
Data Collection Tool: A questionnaire form developed in line with the research purpose was used as a data collection tool in the research.
While collecting data on the individuals participating in the research, the "face-to-face interview method" (mask and distance due to the covid-19 pandemic) by taking necessary precautions such as rules of thumb) will be applied.
Beginning of the Study:
Participants who meet the study criteria and agree to participate in the study will be randomly assigned to the control group or intervention group.
1. Control group protocol; participants randomized to the control group will not receive any dietary intervention. In this process, how all participants should be asked before starting the study.
If they are fed, they will be asked to continue in the same way and to maintain their physical activity level.
2. Intervention group protocol; participants randomized to the intervention group will receive a time-restricted feeding intervention for 6 weeks without energy restriction (adlibitum). Meals of the participants will be planned as 8 hours of eating and 16 hours of fasting.
Meal timing will be set as follows:
* First meal at 10:00,
* Last meal at 18:00 in the evening
Participants will be asked not to consume anything other than non-calorie drinks (water, only soda, unsweetened herbal teas, etc.) between 18:00 in the evening and 10:00 in the morning.
In order to start the study, TR Ministry of Health Nicosia Dr. Necessary permissions were obtained from the Ethics Committee of Burhan Nalbantoğlu State Hospital.
The study is planned to be conducted with 40 female participants, who were not diagnosed with any disease by the physician, aged 19-65, slightly obese, with a BMI of 24.9-29.9 kg/m².
Before being included in the research, participants will be informed about the purpose of the research and the applications to be made during the research.
This information was supported with the valid consent form.
Data Collection Tool: A questionnaire form developed in line with the research purpose was used as a data collection tool in the research.
While collecting data on the individuals participating in the research, the "face-to-face interview method" (mask and distance due to the covid-19 pandemic) by taking necessary precautions such as rules of thumb) will be applied.
Beginning of the Study:
Participants who meet the study criteria and agree to participate in the study will be randomly assigned to the control group or intervention group.
1. Control group protocol; participants randomized to the control group will not receive any dietary intervention. In this process, how all participants should be asked before starting the study.
If they are fed, they will be asked to continue in the same way and to maintain their physical activity level.
2. Intervention group protocol; participants randomized to the intervention group will receive a time-restricted feeding intervention for 6 weeks without energy restriction (adlibitum). Meals of the participants will be planned as 8 hours of eating and 16 hours of fasting.
Meal timing will be set as follows:
* First meal at 10:00,
* Last meal at 18:00 in the evening
Participants will be asked not to consume anything other than non-calorie drinks (water, only soda, unsweetened herbal teas, etc.) between 18:00 in the evening and 10:00 in the morning.
Study Oversight
Has Oversight DMC:
True
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?: