FastingNCT05756868
The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
A study testing Time restricted feeding in people with Fasting, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Time restricted feeding
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 13 Sep 2021to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19-65 age range
- Female
- BMI: 24.9-29.9 kg/m²
- Maintaining general activity and exercise habits during the study period
- Stable body weight (<4 kg weight loss or weight gain) for 6 months prior to the start of the study
Who cannot join
- Those with chronic disease (diabetes, hypertension, cardiovascular disease, etc.)
- Drug users
- Use of supplements that may affect blood lipid profile and blood sugar (omega-3 etc.)
- Pregnant women
- People in the lactation period
- Menopause
Show all 10Show fewer
- Shift workers
- Those who follow a Time Restricted (16:8) nutrition program before the study
- Those who have followed any particular diet before the study
- Those who frequently apply different weight loss diet programs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
- Does time-restricted feeding intervention reduce daily energy intake?
- Does time-restricted dietary intervention result in body weight and body fat loss?
- Does time-limited nutritional intervention lead to improvements in biochemical parameters?
- Does time-restricted feeding intervention improve eating behavior and eating awareness?
- 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.
Read the 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.
- 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.
- 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.
- Conditions
- Fasting
- Being tested
- Time restricted feeding
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted feedingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted feeding | Experimental | 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. Receives: Behavioral: Time restricted feeding |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Body Weight
Measured: 6 week
Body Composition
total body fluid
Measured: 6 week
Body Composition
total fat mass
Measured: 6 week
Body Composition
muscle mass
Measured: 6 week
Body Composition
fat free mass
Measured: 6 week
Plasma lipids
Total cholesterol
Measured: 6 week
Plasma lipids
Hdl cholesterol
Measured: 6 week
Plasma lipids
Ldl cholesterol
Measured: 6 week
Plasma lipids
Triglyceride
Measured: 6 week
Blood Pressure
Systolic blood pressure
Measured: 6 week
Blood Pressure
Diastolic blood pressure
Measured: 6 week
Pulse
Measured: 6 week
Biochemistry
blood glucose
Measured: 6 week
Biochemistry
fasting insulin
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start13 Sep 2021
- Primary completion24 Oct 2021
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşen Yıldırım, Eastern Mediterranean University
- Investigators
- AYŞEN YILDIRIM KIZILDAĞ, PhD, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756868
- Sponsor's protocol ID
- AYildirim
- Status last verified
- Feb 2023
- First submitted
- 25 Nov 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Time-Restricted Feeding Intervention on Anthropometric Measurements, Biochemical Parameters, Diet Quality and Eating Behavior in Overweight Female Individuals
- ClinicalTrials.gov ID
- NCT05756868
- Acronym / sponsor ID
- AYildirim
- Conditions
- Fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does time-restricted feeding intervention reduce daily energy intake?
- Does time-restricted dietary intervention result in body weight and body fat loss?
- Does time-limited nutritional intervention lead to improvements in biochemical parameters?
- Does time-restricted feeding intervention improve eating behavior and eating awareness?
- 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.
- 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time restricted feeding | Experimental | Behavioral: Time restricted feedingThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19-65 age range
- Female
- BMI: 24.9-29.9 kg/m²
- Maintaining general activity and exercise habits during the study period
- Stable body weight (<4 kg weight loss or weight gain) for 6 months prior to the start of the study
Key exclusion criteria (10 listed)
- Those with chronic disease (diabetes, hypertension, cardiovascular disease, etc.)
- Drug users
- Use of supplements that may affect blood lipid profile and blood sugar (omega-3 etc.)
- Pregnant women
- People in the lactation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted feedingIn 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. | Behavioural | Time restricted feeding |
Primary outcome
Body Weight
Time frame: 6 week
Body Weight
Body Composition
Time frame: 6 week
total body fluid
Body Composition
Time frame: 6 week
total fat mass
Body Composition
Time frame: 6 week
muscle mass
Body Composition
Time frame: 6 week
fat free mass
Plasma lipids
Time frame: 6 week
Total cholesterol
Plasma lipids
Time frame: 6 week
Hdl cholesterol
Plasma lipids
Time frame: 6 week
Ldl cholesterol
Plasma lipids
Time frame: 6 week
Triglyceride
Blood Pressure
Time frame: 6 week
Systolic blood pressure
Blood Pressure
Time frame: 6 week
Diastolic blood pressure
Pulse
Time frame: 6 week
Biochemistry
Time frame: 6 week
blood glucose
Biochemistry
Time frame: 6 week
fasting insulin
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: Yes. Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AYŞEN YILDIRIM KIZILDAĞ, PhD principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted feeding in people with Fasting, run by Eastern Mediterranean University at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: 6 week). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.