Obesity & OverweightObesityNCT07378267
Effect of Intermittent Fasting and Mediterranean Diet on Body Composition and Nutritional Intake
A study testing Mediterranean diet and intermittent fasting in people with Obesity & Overweight, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Cardiovascular diseases (CVD), cancer, diabetes, stroke, and chronic lung diseases are non-communicable diseases (NCDs) and account for a significant portion of deaths worldwide. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Mediterranean diet and intermittent fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Feb 2023to 30 Oct 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being between 18-65 years old
- Having a BMI value between 27 kg/m2 - 35 kg/m2
- HBA1C levels between 3.9-6.1
- HOMA IR <2.5
- Not having any conditions that impair reality testing and cognitive functions, preventing interviewing or completing scales
- Being literate
- Having signed the informed consent form by agreeing to participate in the research
Who cannot join
- Being pregnant or breastfeeding,
- Liver and kidney disease,
- Use of insulin and oral antidiabetic drugs,
- Defined as a psychiatric illness diagnosed by a physician.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eda Ocak Nutrition and Diet Consultancy
Konya, Selçuklu, 42100
About this study
Official title: Effect of Intermittent Fasting and Mediterranean Diet on Body Composition and Nutritional Intake in Overweight and Obese Individuals: Randomized Trial
Cardiovascular diseases (CVD), cancer, diabetes, stroke, and chronic lung diseases are non-communicable diseases (NCDs) and account for a significant portion of deaths worldwide. In Turkey, it is estimated that 90% of all deaths are due to NCDs, with 34% due to CVD, 23% due to cancer, 7% due to chronic lung disease, and 5% due to diabetes.
Inadequate and unbalanced nutrition and lack of physical activity contribute to the development of non-communicable diseases. Risk factors such as hypertension, hypercholesterolemia, and obesity are effective in increasing NCDs. In Turkey, it has been found that 32% of NCD-related deaths in individuals over 18 years of age and 10% in adolescents aged 10-19 years are due to obesity risk factors.
All overweight and obese adults with a Body Mass Index (BMI) ≥25 are at risk of developing hypertension, hypercholesterolemia, type 2 diabetes, and CVD. Preventing obesity is effective in preventing these diseases. Weight loss is important in the treatment and prevention of obesity. Changes in body weight are focused on changes in diet and physical activity. Creating an energy deficit is necessary to achieve weight loss, and there are different dietary approaches to reduce energy intake. The Mediterranean diet model and the Intermittent Fasting model are important and being researched in this context.
Read the detailed description
The Mediterranean diet, based on the nutritional patterns of people living in the Mediterranean region, has been found to have a different dietary style and may be effective against CHD and many other diseases. The Mediterranean diet is a model based on a high ratio of monounsaturated and saturated fats, high consumption of legumes, high consumption of fruits and vegetables, low consumption of meat and meat products, and moderate consumption of milk and dairy products. It is thought that the Mediterranean diet can be effective both in preventing diseases and in managing the disease process. In addition, the Mediterranean diet has been used in calorie-restricted diet models due to its effect on obesity and body composition. When the studies in the literature are examined; in a meta-analysis, weight loss was observed in Mediterranean diet models with energy restriction. In an intervention study based on the Mediterranean diet model in obese patients with metabolic syndrome, significant changes occurred in BMI, total fat percentage, total lean mass percentage, and abdominal fat percentage. Another study showed statistically significant changes in body weight and BMI in individuals who underwent Mediterranean diet intervention. Along with this change in body weight, the group with more than 5% weight loss showed a decrease in total cholesterol and triglyceride levels and values such as HOMA-IR in blood parameters. Furthermore, another meta-analysis found that some studies showed that the Mediterranean diet significantly reduced the likelihood of overweight/obesity, supported weight loss, or caused greater weight loss than the control diet, while other studies found no significant association between the Mediterranean diet and overweight/obesity.
Fasting is known as one of the oldest traditions in the world and is practiced among various communities for cultural or religious reasons. Fasting has also been used in the past as a method of treating illnesses. Hippocrates, considered the father of modern medicine, emphasized the importance of fasting during illness with his statement, "To eat when you are sick is to feed your illness". Intermittent fasting, that is, periods of voluntary abstinence from food and drink, is an ancient practice followed in different forms by many populations worldwide. Intermittent fasting involves fasting or restricted eating at certain times of the day or on certain days of the week. Alternate-day fasting involves alternating days when food and drinks are consumed with days when energy-containing foods or drinks are not consumed. In alternate-day fasting, approximately 20-25% of energy requirements are met on fasting days. Modified fasting is also known as the 5:2 method. This dietary model involves a very low-calorie diet on 2 non-consecutive days of the week, and normal energy requirements without energy restriction on the other 5 days. Another approach is time-restricted eating, which is used to describe an eating pattern where food intake is limited to a time window of 8 hours or less each da. Welton et al. reported that the ideal fasting period for positive weight change is 16 hours. In recent years, small-scale human studies demonstrating the importance of time-ricted eating have become widespread. Most of these studies, as in animal studies, have revealed the beneficial aspects of intermittent fasting in human metabolism. With time-restricted eating, reductions in energy intake, body weight, body fat, blood sugar, triglycerides, glucose tolerance, and inflammatory markers have been observed. Among fasting methods are religious fasts, such as Ramadan, which allow eating after sunset and before dawn. Since the fasting and eating periods last approximately 12 hours and the amount of energy given is not limited, it is a type of time-restricted eating.
Intermittent fasting, which has become a popular topic recently, is an alternative energy restriction method. Time-restricted eating, alternate-day fasting, the 5:2 diet, and Ramadan fasting are the most frequently used fasting protocols in the literature. Although daily energy restriction is the most commonly used diet model for achieving weight loss and improving body composition and metabolic health, intermittent fasting practices have become a focus of interest in recent years.
A review of studies in the literature revealed statistically significant differences in pre- and post-intervention body weight and BMI in 33 adults who underwent an 8-hour time-restricted feeding model for four weeks. A randomized controlled trial of 16 men and women (BMI 20-39 kg/m²) conducted over 10 weeks examined changes in body composition between the intervention and control groups using a time-restricted feeding model without energy restriction. According to Liu et al., no significant differences were found between the experimental and control groups in terms of reduction in body weight, body fat, or metabolic risk factors in obese individuals who underwent a time-restricted feeding model. A significant decrease in body fat percentage was observed in the time-restricted feeding model compared to the control group, while there was no significant change in body weight in either group. In another study, 101 overweight and obese adults were randomized into an alternate-day fasting group (n=34), a 16/8 time-restricted feeding group (n=33), and a control group (n=34). In the alternating-day fasting and 16/8 time-restricted eating groups, reductions in body weight, body mass index, and waist circumference were found to be more significant compared to the control group. Furthermore, the reductions in body weight and BMI in the alternating-day fasting group were more significant than those in the 16/8 group. In another randomized controlled trial of 40 obese young people aged 18-25, the intervention group underwent a 5:2 intermittent fasting diet, while the control group continued their previous eating habits. After a four-week intervention, the group undergoing 5:2 intermittent fasting showed a statistically significant decrease in energy intake and BMI compared to the control group. In contrast, Witjaksono et al. monitored weight loss in 50 obese participants using a 5:2 modified diet model (n=25) and a control group (n=25). While there were no significant changes in fat mass, lean mass, skeletal muscle, and BMI between the groups, reductions in carbohydrate, protein, and fat intake were statistically significant in both groups.
In conclusion, the prevalence of noncommunicable diseases is increasing today, and obesity is among the important risk factors for these diseases. While many methods are used in the treatment of obesity, medical nutritional therapies are also important. Different methods are used in medical nutritional therapies for obesity, including calorie-restricted Mediterranean diets and time-restricted eating models, which are one of the intermittent fasting models. This study aimed to examine the effect of dietary models on body composition and dietary intake in the management of obesity.
- Conditions
- Obesity & Overweight
- Being tested
- Mediterranean diet, intermittent fasting
- Keywords
- intermittent fasting, Mediterranean diet
- Medical subject headings
- Obesity, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean dietOther
The participants in the study were divided into two different diet groups: Mediterranean diet (MD) and intermittent fasting (IF). The "Harris Benedict" formula was used to calculate the Basal Metabolic Rate (BMR) of the individuals. For men, the BMR was calculated as 66.5 + (13.7516 × weight in kg) + (5.0033 × height in cm) - (6.755 × age in years); for women, the BMR was calculated as 655.1 + (9.5634 × weight in kg) + (1.8496 × height in cm) - (4.6756 × age in years). Physical activity level (PAL) was determined as follows: sedentary physical activity level 1-1.39; light physical activity level 1.4-1.59; moderate physical activity level 1.6-1.89; and heavy physical activity level 1.9-2.5. Total energy expenditure (TED) was calculated using the formula: TED (kcal/day) = BMR (kcal/day) x PAL (Ministry of Health, 2017). For the group following the Mediterranean diet, diet plans were prepared containing 35-40% carbohydrates, 15-20% protein, and 35-45% fat of daily energy. A nutritional pr
intermittent fastingOther
The participants in the study were divided into two different diet groups: Mediterranean diet (MD) and intermittent fasting (IF). The "Harris Benedict" formula was used to calculate the Basal Metabolic Rate (BMR) of the individuals. For men, the BMR was calculated as 66.5 + (13.7516 × weight in kg) + (5.0033 × height in cm) - (6.755 × age in years); for women, the BMR was calculated as 655.1 + (9.5634 × weight in kg) + (1.8496 × height in cm) - (4.6756 × age in years). Physical activity level (PAL) was determined as follows: sedentary physical activity level 1-1.39; light physical activity level 1.4-1.59; moderate physical activity level 1.6-1.89; and heavy physical activity level 1.9-2.5. Total energy expenditure (TED) was calculated using the formula: TED (kcal/day) = BMR (kcal/day) x PAL (Ministry of Health, 2017). Individuals in the intermittent fasting group also had time restrictions applied in addition to the Mediterranean diet group. Time preferences were determined as 16/8, 14
| Study group | Role | What they receive |
|---|---|---|
| Mediterranean diet group | Active comparator | Mediterranean diet Receives: Other: Mediterranean diet |
| intermittent fasting group | Active comparator | intermittent fasting Receives: Other: intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Nutrition Knowledge Level (ADHL) Scale
The survey form containing Basic Nutrition and Food-Health Information will be completed. Participants who marked "Strongly Agree" for correct statements received 4 points, those who marked "Agree" received 3 points, those who marked "Neither Agree nor Disagree" received 2 points, those who chose "Disagree" received 1 point, and those who chose "Strongly Disagree" received 0 points. Items 1, 3, 6, 8, 13, 16, 19, and 20 of the scale are reverse scored. The highest possible score for the basic nutrition section is 80; the highest possible score for the food preference section is 48. A basic nutrition score of <45 is considered poor, 45-55 is considered average, 56-65 is considered good, and 65 and above is considered very good. In terms of food preference scores, a score of <30 is considered poor, 30-36 points are considered average, 37-42 points are considered good, and 42 points and above are considered very good.
Measured: 8 weeks
Body fat percentage (%Fat)
Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA).
Body fat percentage (%Fat) will be measured using TANITA MC 580.
Measured: 8 weeks
Secondary outcomes (3)
Body fat mass (kg)
Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA).
Body fat mass (kg) will be measured using TANITA MC 580.
Measured: 8 weeks
Weight
Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA).
Weight will be measured using TANITA MC 580.
Measured: 8 weeks
Body mass index (BMI)
Body mass index (BMI) will be calculated using the equation where body weight is divided by the square of height in meters, and will be evaluated according to the World Health Organization's classification for adults.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start18 Feb 2023
- Primary completion18 May 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was planned as a randomized trial using a dietary intervention method (Mediterranean Diet intervention group and Intermittent Fasting Diet group). First, inclusion criteria for randomization were determined, and 100 participants meeting these criteria who applied to a private diet clinic after a health screening from a family physician in Selçuklu district of Konya province will be assigned numbers. Individuals will be placed in the group corresponding to the dietary intervention group with the number they received in randomization. Dietary intervention will be applied to both groups in the study. After obtaining informed consent from the participants, an 8-week follow-up period will begin.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SUHİDE BİLGE HORZUM, Selcuk University
- Investigators
- Ebru Bayrak, assistant professor, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378267
- Sponsor's protocol ID
- 2023/54
- Acronym
- Obesity
- Status last verified
- Jan 2026
- First submitted
- 17 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication.
Publications
Antoni, R., Robertson, T. M., Robertson, M. D., Johnston, J. (2018). A pilot feasibility study exploring the effects of a moderate time-restricted feeding intervention on energy intake, adiposity and metabolic physiology in free-living human subjects. 7. doi:https://doi.org/10.1017/jns.2018.13
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent Fasting and Mediterranean Diet on Body Composition and Nutritional Intake in Overweight and Obese Individuals: Randomized Trial
- ClinicalTrials.gov ID
- NCT07378267
- Acronym / sponsor ID
- Obesity / 2023/54
- Conditions
- Obesity & Overweight
- Keywords
- intermittent fasting, Mediterranean diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 18 May 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 30 Jan 2026 (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.
Cardiovascular diseases (CVD), cancer, diabetes, stroke, and chronic lung diseases are non-communicable diseases (NCDs) and account for a significant portion of deaths worldwide. In Turkey, it is estimated that 90% of all deaths are due to NCDs, with 34% due to CVD, 23% due to cancer, 7% due to chronic lung disease, and 5% due to diabetes.
Inadequate and unbalanced nutrition and lack of physical activity contribute to the development of non-communicable diseases. Risk factors such as hypertension, hypercholesterolemia, and obesity are effective in increasing NCDs. In Turkey, it has been found that 32% of NCD-related deaths in individuals over 18 years of age and 10% in adolescents aged 10-19 years are due to obesity risk factors.
All overweight and obese adults with a Body Mass Index (BMI) ≥25 are at risk of developing hypertension, hypercholesterolemia, type 2 diabetes, and CVD. Preventing obesity is effective in preventing these diseases. Weight loss is important in the treatment and prevention of obesity. Changes in body weight are focused on changes in diet and physical activity. Creating an energy deficit is necessary to achieve weight loss, and there are different dietary approaches to reduce energy intake. The Mediterranean diet model and the Intermittent Fasting model are important and being researched in this context.
Detailed description
The Mediterranean diet, based on the nutritional patterns of people living in the Mediterranean region, has been found to have a different dietary style and may be effective against CHD and many other diseases. The Mediterranean diet is a model based on a high ratio of monounsaturated and saturated fats, high consumption of legumes, high consumption of fruits and vegetables, low consumption of meat and meat products, and moderate consumption of milk and dairy products. It is thought that the Mediterranean diet can be effective both in preventing diseases and in managing the disease process. In addition, the Mediterranean diet has been used in calorie-restricted diet models due to its effect on obesity and body composition. When the studies in the literature are examined; in a meta-analysis, weight loss was observed in Mediterranean diet models with energy restriction. In an intervention study based on the Mediterranean diet model in obese patients with metabolic syndrome, significant changes occurred in BMI, total fat percentage, total lean mass percentage, and abdominal fat percentage. Another study showed statistically significant changes in body weight and BMI in individuals who underwent Mediterranean diet intervention. Along with this change in body weight, the group with more than 5% weight loss showed a decrease in total cholesterol and triglyceride levels and values such as HOMA-IR in blood parameters. Furthermore, another meta-analysis found that some studies showed that the Mediterranean diet significantly reduced the likelihood of overweight/obesity, supported weight loss, or caused greater weight loss than the control diet, while other studies found no significant association between the Mediterranean diet and overweight/obesity.
Fasting is known as one of the oldest traditions in the world and is practiced among various communities for cultural or religious reasons. Fasting has also been used in the past as a method of treating illnesses. Hippocrates, considered the father of modern medicine, emphasized the importance of fasting during illness with his statement, "To eat when you are sick is to feed your illness". Intermittent fasting, that is, periods of voluntary abstinence from food and drink, is an ancient practice followed in different forms by many populations worldwide. Intermittent fasting involves fasting or restricted eating at certain times of the day or on certain days of the week. Alternate-day fasting involves alternating days when food and drinks are consumed with days when energy-containing foods or drinks are not consumed. In alternate-day fasting, approximately 20-25% of energy requirements are met on fasting days. Modified fasting is also known as the 5:2 method. This dietary model involves a very low-calorie diet on 2 non-consecutive days of the week, and normal energy requirements without energy restriction on the other 5 days. Another approach is time-restricted eating, which is used to describe an eating pattern where food intake is limited to a time window of 8 hours or less each da. Welton et al. reported that the ideal fasting period for positive weight change is 16 hours. In recent years, small-scale human studies demonstrating the importance of time-ricted eating have become widespread. Most of these studies, as in animal studies, have revealed the beneficial aspects of intermittent fasting in human metabolism. With time-restricted eating, reductions in energy intake, body weight, body fat, blood sugar, triglycerides, glucose tolerance, and inflammatory markers have been observed. Among fasting methods are religious fasts, such as Ramadan, which allow eating after sunset and before dawn. Since the fasting and eating periods last approximately 12 hours and the amount of energy given is not limited, it is a type of time-restricted eating.
Intermittent fasting, which has become a popular topic recently, is an alternative energy restriction method. Time-restricted eating, alternate-day fasting, the 5:2 diet, and Ramadan fasting are the most frequently used fasting protocols in the literature. Although daily energy restriction is the most commonly used diet model for achieving weight loss and improving body composition and metabolic health, intermittent fasting practices have become a focus of interest in recent years.
A review of studies in the literature revealed statistically significant differences in pre- and post-intervention body weight and BMI in 33 adults who underwent an 8-hour time-restricted feeding model for four weeks. A randomized controlled trial of 16 men and women (BMI 20-39 kg/m²) conducted over 10 weeks examined changes in body composition between the intervention and control groups using a time-restricted feeding model without energy restriction. According to Liu et al., no significant differences were found between the experimental and control groups in terms of reduction in body weight, body fat, or metabolic risk factors in obese individuals who underwent a time-restricted feeding model. A significant decrease in body fat percentage was observed in the time-restricted feeding model compared to the control group, while there was no significant change in body weight in either group. In another study, 101 overweight and obese adults were randomized into an alternate-day fasting group (n=34), a 16/8 time-restricted feeding group (n=33), and a control group (n=34). In the alternating-day fasting and 16/8 time-restricted eating groups, reductions in body weight, body mass index, and waist circumference were found to be more significant compared to the control group. Furthermore, the reductions in body weight and BMI in the alternating-day fasting group were more significant than those in the 16/8 group. In another randomized controlled trial of 40 obese young people aged 18-25, the intervention group underwent a 5:2 intermittent fasting diet, while the control group continued their previous eating habits. After a four-week intervention, the group undergoing 5:2 intermittent fasting showed a statistically significant decrease in energy intake and BMI compared to the control group. In contrast, Witjaksono et al. monitored weight loss in 50 obese participants using a 5:2 modified diet model (n=25) and a control group (n=25). While there were no significant changes in fat mass, lean mass, skeletal muscle, and BMI between the groups, reductions in carbohydrate, protein, and fat intake were statistically significant in both groups.
In conclusion, the prevalence of noncommunicable diseases is increasing today, and obesity is among the important risk factors for these diseases. While many methods are used in the treatment of obesity, medical nutritional therapies are also important. Different methods are used in medical nutritional therapies for obesity, including calorie-restricted Mediterranean diets and time-restricted eating models, which are one of the intermittent fasting models. This study aimed to examine the effect of dietary models on body composition and dietary intake in the management of obesity.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was planned as a randomized trial using a dietary intervention method (Mediterranean Diet intervention group and Intermittent Fasting Diet group). First, inclusion criteria for randomization were determined, and 100 participants meeting these criteria who applied to a private diet clinic after a health screening from a family physician in Selçuklu district of Konya province will be assigned numbers. Individuals will be placed in the group corresponding to the dietary intervention group with the number they received in randomization. Dietary intervention will be applied to both groups in the study. After obtaining informed consent from the participants, an 8-week follow-up period will begin.
| Arm | Type | Receives |
|---|---|---|
| Mediterranean diet group | Active comparator | Other: Mediterranean dietMediterranean diet |
| intermittent fasting group | Active comparator | Other: intermittent fastingintermittent fasting |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Being between 18-65 years old
- Having a BMI value between 27 kg/m2 - 35 kg/m2
- HBA1C levels between 3.9-6.1
- HOMA IR <2.5
- Not having any conditions that impair reality testing and cognitive functions, preventing interviewing or completing scales
Key exclusion criteria (4 listed)
- Being pregnant or breastfeeding,
- Liver and kidney disease,
- Use of insulin and oral antidiabetic drugs,
- Defined as a psychiatric illness diagnosed by a physician.
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 |
|---|---|---|
| Mediterranean dietThe participants in the study were divided into two different diet groups: Mediterranean diet (MD) and intermittent fasting (IF). The "Harris Benedict" formula was used to calculate the Basal Metabolic Rate (BMR) of the individuals. For men, the BMR was calculated as 66.5 + (13.7516 × weight in kg) + (5.0033 × height in cm) - (6.755 × age in years); for women, the BMR was calculated as 655.1 + (9.5634 × weight in kg) + (1.8496 × height in cm) - (4.6756 × age in years). Physical activity level (PAL) was determined as follows: sedentary physical activity level 1-1.39; light physical activity level 1.4-1.59; moderate physical activity level 1.6-1.89; and heavy physical activity level 1.9-2.5. Total energy expenditure (TED) was calculated using the formula: TED (kcal/day) = BMR (kcal/day) x PAL (Ministry of Health, 2017). For the group following the Mediterranean diet, diet plans were prepared containing 35-40% carbohydrates, 15-20% protein, and 35-45% fat of daily energy. A nutritional pr | Other | Mediterranean diet group |
| intermittent fastingThe participants in the study were divided into two different diet groups: Mediterranean diet (MD) and intermittent fasting (IF). The "Harris Benedict" formula was used to calculate the Basal Metabolic Rate (BMR) of the individuals. For men, the BMR was calculated as 66.5 + (13.7516 × weight in kg) + (5.0033 × height in cm) - (6.755 × age in years); for women, the BMR was calculated as 655.1 + (9.5634 × weight in kg) + (1.8496 × height in cm) - (4.6756 × age in years). Physical activity level (PAL) was determined as follows: sedentary physical activity level 1-1.39; light physical activity level 1.4-1.59; moderate physical activity level 1.6-1.89; and heavy physical activity level 1.9-2.5. Total energy expenditure (TED) was calculated using the formula: TED (kcal/day) = BMR (kcal/day) x PAL (Ministry of Health, 2017). Individuals in the intermittent fasting group also had time restrictions applied in addition to the Mediterranean diet group. Time preferences were determined as 16/8, 14 | Other | intermittent fasting group |
Primary outcome
Adult Nutrition Knowledge Level (ADHL) Scale
Time frame: 8 weeks
The survey form containing Basic Nutrition and Food-Health Information will be completed. Participants who marked "Strongly Agree" for correct statements received 4 points, those who marked "Agree" received 3 points, those who marked "Neither Agree nor Disagree" received 2 points, those who chose "Disagree" received 1 point, and those who chose "Strongly Disagree" received 0 points. Items 1, 3, 6, 8, 13, 16, 19, and 20 of the scale are reverse scored. The highest possible score for the basic nutrition section is 80; the highest possible score for the food preference section is 48. A basic nutrition score of <45 is considered poor, 45-55 is considered average, 56-65 is considered good, and 65 and above is considered very good. In terms of food preference scores, a score of <30 is considered poor, 30-36 points are considered average, 37-42 points are considered good, and 42 points and above are considered very good.
Body fat percentage (%Fat)
Time frame: 8 weeks
Individuals' body weights and body compositions will be measured using foot-to-foot bioelectrical impedance analysis (BIA). Body fat percentage (%Fat) will be measured using TANITA MC 580.
3 secondary outcomes
Body fat mass (kg)
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Body mass index (BMI)
Time frame: 8 weeks
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 30 Jan 2026.
- Results publicationAntoni, R., Robertson, T. M., Robertson, M. D., Johnston, J. (2018). A pilot feasibility study exploring the effects of a moderate time-restricted feeding intervention on energy intake, adiposity and metabolic physiology in free-living human subjects. 7. doi:https://doi.org/10.1017/jns.2018.13
- Individual participant dataSharing planned: Yes. only IPD used in the results publication.
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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.
Ebru Bayrak, assistant professor study director
Selcuk 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 Mediterranean diet and intermittent fasting in people with Obesity & Overweight, run by Selcuk University at 1 site in Turkey (Türkiye).
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 7 inclusion and 4 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 30 Jan 2026. 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 Turkey (Türkiye). 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?
Adult Nutrition Knowledge Level (ADHL) Scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07378267, which also lists 1 linked publication.
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 30 Jan 2026.