The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior

The Effect of Time-Restricted Feeding Intervention on Anthropometric Measurements, Biochemical Parameters, Diet Quality and Eating Behavior in Overweight Female Individuals

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.

Study Overview

• Status: Completed
• Conditions: Fasting
• Intervention / Treatment: Behavioral: Time restricted feeding

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Famagusta, Cyprus, 99628
    • Eastern Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. 19-65 age range
2. Female
3. BMI: 24.9-29.9 kg/m²
4. Maintaining general activity and exercise habits during the study period
5. Stable body weight (<4 kg weight loss or weight gain) for 6 months prior to the start of the study

Exclusion Criteria:

1. Those with chronic disease (diabetes, hypertension, cardiovascular disease, etc.)
2. Drug users
3. Use of supplements that may affect blood lipid profile and blood sugar (omega-3 etc.)
4. Pregnant women
5. People in the lactation period
6. Menopause
7. Shift workers
8. Those who follow a Time Restricted (16:8) nutrition program before the study
9. Those who have followed any particular diet before the study
10. Those who frequently apply different weight loss diet programs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time restricted feeding; 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.	Behavioral: Time restricted feeding; In the time-restricted nutrition intervention, the first meal is scheduled at 10:00 and the last meal at 18:00 (ad libitum). Eating for 8 hours and fasting for 16 hours are targeted.
No Intervention: Control; Participants in the control group will not receive any dietary intervention. All participants were asked to continue in the same way they were fed before starting the study throughout the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Body Weight	6 week
Body Composition	total body fluid	6 week
Body Composition	total fat mass	6 week
Body Composition	muscle mass	6 week
Body Composition	fat free mass	6 week
Plasma lipids	Total cholesterol	6 week
Plasma lipids	Hdl cholesterol	6 week
Plasma lipids	Ldl cholesterol	6 week
Plasma lipids	Triglyceride	6 week
Blood Pressure	Systolic blood pressure	6 week
Blood Pressure	Diastolic blood pressure	6 week
Pulse		6 week
Biochemistry	blood glucose	6 week
Biochemistry	fasting insulin	6 week

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Principal Investigator: AYŞEN YILDIRIM KIZILDAĞ, PhD, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): October 24, 2021
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: November 25, 2022
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Estimate): March 6, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AYildirim

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: No individual participant data will be shared. Results will be published by the investigators in academic journals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No