Weight LossNCT07250659
Comparing Intermittent Fasting and Mediterranean Diet for Obesity
A study testing Intermittent Fasting Diet and Mediterranean Diet in people with Weight Loss, run by Kamil Dağcılar at 1 site in Cyprus.
Trial summary
Purpose: This study aimed to evaluate and compare the effects of intermittent fasting (IF) and the Mediterranean diet (MD) on weight loss in obese adults. Methods: A total of 120 adults diagnosed with obesity were enrolled. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Intermittent Fasting Diet and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Sep 2022to 30 Dec 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI ≥ 30 kg/m²
- absence of chronic diseases
- no regular use of medications
- non smokers
- non alcohol users
- not pregnant or breastfeeding
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- no history of bariatric surgery
- no significant weight fluctuations (±5 kg) in the past 6 months
- no pregnancy plans during the study period
Who cannot join
- BMI < 30 kg/m²
- Presence of any diagnosed chronic disease (e.g., diabetes, cardiovascular disease, thyroid disorders, renal or hepatic disease)
- Regular use of medications that could affect metabolism, appetite, or body weight
- Smoking or alcohol consumption
- Pregnancy or breastfeeding during the study period
- History of bariatric or other weight-related surgical procedures
Show all 9Show fewer
- Significant weight changes (gain or loss ≥5 kg) within the past 6 months
- Planning pregnancy during the study period
- Inability or unwillingness to comply with dietary intervention and follow-up requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Intermittent Fasting Versus Mediterranean Diet on Obesity Management: A Randomized Controlled Trial
Purpose: This study aimed to evaluate and compare the effects of intermittent fasting (IF) and the Mediterranean diet (MD) on weight loss in obese adults.
Methods: A total of 120 adults diagnosed with obesity were enrolled. Baseline data on physical activity and dietary intake were collected through structured interviews. Participants were randomly assigned to two groups for a 4-week intervention. The IF group followed a time-restricted eating schedule (16:8), while the MD group followed a structured plan of three main meals and three snacks daily. Both diets included a 500-calorie daily reduction from estimated energy needs. Anthropometric measurements were recorded at baseline and week 4.
- Conditions
- Weight Loss
- Being tested
- Intermittent Fasting Diet, Mediterranean Diet
- Keywords
- obesity, intermittent fasting, weight loss, mediterranean diet
- Medical subject headings
- Weight Loss, Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Fasting DietOther
Participants follow a time-restricted eating pattern for 4 weeks, consuming all meals within an 8-hour eating window (from 1:00 PM to 9:00 PM) and fasting for the remaining 16 hours each day. During the feeding window, they consume two main meals and one snack based on ad libitum intake, without specific calorie restriction. Dietary guidance is provided at the start and mid-point of the protocol by a registered dietitian.
Mediterranean DietOther
Participants follow a 4-week Mediterranean diet protocol that is adapted from the PREDIMED criteria and the MedDietScore index. The diet emphasizes high consumption of vegetables, fruits, legumes, whole grains, nuts, and olive oil; moderate intake of fish and poultry; and limited consumption of red meat, dairy products, and sweets. A registered dietitian provides dietary counseling sessions at the beginning and midway through the intervention.
| Study group | Role | What they receive |
|---|---|---|
| intermittent fasting diet intervention group | Experimental | 4 week time restricted intermittent fasting diet protocol Receives: Other: Intermittent Fasting Diet |
| Mediterranean diet intervention group | Experimental | 4 week mediterranean diet protocol Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight (kg)
Body weight is measured with using the TANITA BC-418 body composition analyzer. Participants are weighed barefoot, in light clothing, and measurements are recorded in kilograms.
Measured: Baseline and Week 4
Secondary outcomes (1)
Body Mass Index (kg/m²)
BMI is computed as weight in kilograms divided by height in meters squared (kg/m²)
Measured: Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Sep 2022
- Primary completion25 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamil Dağcılar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kamil Dağcılar, European University of Lefke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250659
- Sponsor's protocol ID
- BAYEK011.02
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Intermittent Fasting Versus Mediterranean Diet on Obesity Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07250659
- Acronym / sponsor ID
- BAYEK011.02
- Conditions
- Weight Loss
- Keywords
- obesity, intermittent fasting, weight loss, mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kamil DağcılarUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 26 Nov 2025 (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.
Purpose: This study aimed to evaluate and compare the effects of intermittent fasting (IF) and the Mediterranean diet (MD) on weight loss in obese adults.
Methods: A total of 120 adults diagnosed with obesity were enrolled. Baseline data on physical activity and dietary intake were collected through structured interviews. Participants were randomly assigned to two groups for a 4-week intervention. The IF group followed a time-restricted eating schedule (16:8), while the MD group followed a structured plan of three main meals and three snacks daily. Both diets included a 500-calorie daily reduction from estimated energy needs. Anthropometric measurements were recorded at baseline and week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intermittent fasting diet intervention group | Experimental | Other: Intermittent Fasting Diet4 week time restricted intermittent fasting diet protocol |
| Mediterranean diet intervention group | Experimental | Other: Mediterranean Diet4 week mediterranean diet protocol |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- BMI ≥ 30 kg/m²
- absence of chronic diseases
- no regular use of medications
- non smokers
- non alcohol users
Key exclusion criteria (9 listed)
- BMI < 30 kg/m²
- Presence of any diagnosed chronic disease (e.g., diabetes, cardiovascular disease, thyroid disorders, renal or hepatic disease)
- Regular use of medications that could affect metabolism, appetite, or body weight
- Smoking or alcohol consumption
- Pregnancy or breastfeeding during the study 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 |
|---|---|---|
| Intermittent Fasting DietParticipants follow a time-restricted eating pattern for 4 weeks, consuming all meals within an 8-hour eating window (from 1:00 PM to 9:00 PM) and fasting for the remaining 16 hours each day. During the feeding window, they consume two main meals and one snack based on ad libitum intake, without specific calorie restriction. Dietary guidance is provided at the start and mid-point of the protocol by a registered dietitian. | Other | intermittent fasting diet intervention group |
| Mediterranean DietParticipants follow a 4-week Mediterranean diet protocol that is adapted from the PREDIMED criteria and the MedDietScore index. The diet emphasizes high consumption of vegetables, fruits, legumes, whole grains, nuts, and olive oil; moderate intake of fish and poultry; and limited consumption of red meat, dairy products, and sweets. A registered dietitian provides dietary counseling sessions at the beginning and midway through the intervention. | Other | Mediterranean diet intervention group |
Primary outcome
Body weight (kg)
Time frame: Baseline and Week 4
Body weight is measured with using the TANITA BC-418 body composition analyzer. Participants are weighed barefoot, in light clothing, and measurements are recorded in kilograms.
1 secondary outcome
Body Mass Index (kg/m²)
Time frame: Baseline and Week 4
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 26 Nov 2025.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting Diet and Mediterranean Diet in people with Weight Loss, run by Kamil Dağcılar 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 9 inclusion and 9 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 26 Nov 2025. 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 (kg) (time frame: Baseline and Week 4). 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 26 Nov 2025.