ObesityNCT07695480
Metabolic Effects of Diet-Exercise Interventions in Obesity
A study testing Home-Based Exercise Program, Semi-Vegetarian Diet and Intermittent Fasting in people with Obesity and Metabolic Changes, run by Firat University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the effects of different dietary strategies (ketogenic diet, intermittent fasting, and semi-vegetarian diet), alone or in combination with a structured home-based exercise program, on anthropometric, metabolic, and hormonal parameters in women with obesity. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Changes, Hormonal Changes
- What is being tested?
- Home-Based Exercise Program, Semi-Vegetarian Diet and Intermittent Fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2023to 12 Jan 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically and physically fit for exercise interventions.
- No participation in any structured dietary programs within the previous 3 months.
- Lack of orthopedic limitations that would prevent safe physical activity.
Who cannot join
- Pregnancy or lactation.
- Chronic conditions such as cancer, renal failure, or hepatic failure.
- Diagnosed psychiatric disorders.
- History of adverse reactions to venipuncture.
- Inability or unwillingness to adhere to the assigned dietary and exercise intervention protocols.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Responses of Diet-Exercise Combinations in Women With Obesity: A Comparative Lifestyle Intervention Study With Different Diet Types
This study investigates the effects of different dietary strategies (ketogenic diet, intermittent fasting, and semi-vegetarian diet), alone or in combination with a structured home-based exercise program, on anthropometric, metabolic, and hormonal parameters in women with obesity. A total of 108 participants aged 19-45 years are allocated into nine groups, including control, exercise-only, diet-only, and combined intervention groups. Anthropometric outcomes (body weight, body mass index, and body fat percentage) and biochemical markers (glucose, insulin, adiponectin, IGF-1, irisin, and myostatin) are assessed at baseline and after a 6-week intervention period using bioelectrical impedance analysis and ELISA methods.
- Conditions
- Obesity, Metabolic Changes, Hormonal Changes
- Being tested
- Home-Based Exercise Program, Semi-Vegetarian Diet, Intermittent Fasting, Ketogenic Diet
- Keywords
- Adipokines, exercise therapy, fasting, IGF-1, ketogenic diet, myokines, obesity, semi-vegetarian diet
- Medical subject headings
- Obesity, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-Based Exercise ProgramBehavioural
Also called Structured Physical Exercise
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Semi-Vegetarian DietOther
Also called Flexitarian Dietary Intervention
A 6-week structured semi-vegetarian dietary protocol primarily based on plant foods with occasional inclusion of meat or fish, designed for caloric control and metabolic tracking.
Intermittent FastingOther
Also called Time-Restricted Feeding (TRF)
A 6-week structured intermittent fasting protocol regulating specific eating and fasting windows each day to evaluate its effects on body composition and metabolic markers.
Ketogenic DietOther
Also called Very Low-Carbonhydrate Ketogenic Diet (VLCKD)
A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.
| Study group | Role | What they receive |
|---|---|---|
| Control (C) | No intervention | This group consists of 12 individuals with normal weight who do not receive any dietary or exercise interventions. They maintain their habitual lifestyle, physical activity, and dietary patterns for 6 weeks. |
| Obese (O) | No intervention | This group consists of 12 individuals with obesity who do not receive any dietary or exercise interventions. They maintain their regular lifestyle, physical activity, and dietary habits for 6 weeks. |
| Obese with exercise (OE) | Experimental | This group consists of 12 individuals with obesity who participate in a structured home-based exercise program for 6 weeks, without any dietary modifications. Receives: Behavioral: Home-Based Exercise Program |
| Obese with exercise plus semi-vegetarian diet (OEVD) | Experimental | This group consists of 12 individuals with obesity who follow a structured semi-vegetarian dietary protocol combined with a home-based exercise program for 6 weeks. Receives: Behavioral: Home-Based Exercise Program; Other: Semi-Vegetarian Diet |
| Obese with semi-vegetarian diet (OVD) | Experimental | This group consists of 12 individuals with obesity who follow a structured semi-vegetarian dietary protocol for 6 weeks, without participating in any exercise program. Receives: Other: Semi-Vegetarian Diet |
| Obese with exercise plus intermittent fasting (OEIF) | Experimental | This group consists of 12 individuals with obesity who follow a structured intermittent fasting protocol combined with a home-based exercise program for 6 weeks. Receives: Behavioral: Home-Based Exercise Program; Other: Intermittent Fasting |
| Obese with intermittent fasting (OIF) | Experimental | This group consists of 12 individuals with obesity who follow a structured intermittent fasting protocol for 6 weeks, without participating in any exercise program. Receives: Other: Intermittent Fasting |
| Obese with exercise plus ketogenic diet (OEKD) | Experimental | This group consists of 12 individuals with obesity who follow a structured ketogenic dietary protocol combined with a home-based exercise program for 6 weeks. Receives: Behavioral: Home-Based Exercise Program; Other: Ketogenic Diet |
| Obese with ketogenic diet (OKD) | Experimental | This group consists of 12 individuals with obesity who follow a structured ketogenic dietary protocol for 6 weeks, without participating in any exercise program. Receives: Other: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Body weight will be measured in kilograms (kg) using a calibrated Bioelectrical Impedance Analysis (BIA) device (Omron Karadascan HBF-511, Japan). The outcome will evaluate the effectiveness of the 6-week lifestyle interventions on body mass reduction compared to baseline.
Measured: Baseline and 6 weeks
Secondary outcomes (9)
Change in Body Mass Index (BMI)
Body Mass Index will be calculated using the formula weight in kilograms divided by height in meters squared (kg/m²). Height will be measured using a stadiometer (Holtain Ltd., UK) and weight via a Bioelectrical Impedance Analysis (BIA) device (Omron Karadascan HBF-511, Japan).
Measured: Baseline and week 6
Change in Body Fat Percentage
Body fat percentage (%) will be measured using a Bioelectrical Impedance Analysis (BIA) device (Omron Karadascan HBF-511, Japan) to evaluate the proportion of fat tissue relative to total body weight.
Measured: Baseline and week 6
Change in Skeletal Muscle Percentage
Skeletal muscle percentage (%) will be measured using a Bioelectrical Impedance Analysis (BIA) device (Omron Karadascan HBF-511, Japan) to evaluate the proportion of muscle tissue relative to total body weight.
Measured: Baseline and week 6
Change in Fasting Blood Glucose
Fasting blood glucose levels will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) method from venous blood samples to evaluate the effects of the interventions on glycemic control.
Measured: Baseline and week 6
Change in Fasting Insulin
Fasting insulin levels will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) method from venous blood samples to assess pancreatic beta-cell function and insulin dynamics.
Measured: Baseline and week 6
Change in Adiponectin Levels
Serum adiponectin levels will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) from venous blood samples to evaluate changes in adipokine secretion and insulin sensitivity.
Measured: Baseline and week 6
Change in Insulin-Like Growth Factor 1 (IGF-1) Levels
Serum IGF-1 levels will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) from venous blood samples to evaluate alterations in growth hormone axis and metabolic adaptation.
Measured: Baseline and week 6
Change in Irisin Levels
Serum irisin levels will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) from venous blood samples to track changes in myokine secretion in response to physical activity and dietary interventions.
Measured: Baseline and week 6
Change in Myostatin Levels
Serum myostatin levels will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) from venous blood samples to assess skeletal muscle mass regulation and myokine alterations.
Measured: Baseline and week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Jul 2023
- Primary completion15 Dec 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Firat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Subaşı, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695480
- Sponsor's protocol ID
- FSU-OBES-DIETEX-2026-01
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: İndividual participant data will not be shared because participant consent for public data sharing was not obtained.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Responses of Diet-Exercise Combinations in Women With Obesity: A Comparative Lifestyle Intervention Study With Different Diet Types
- ClinicalTrials.gov ID
- NCT07695480
- Acronym / sponsor ID
- FSU-OBES-DIETEX-2026-01
- Conditions
- Obesity, Metabolic Changes, Hormonal Changes
- Keywords
- Adipokines, exercise therapy, fasting, IGF-1, ketogenic diet, myokines, obesity, semi-vegetarian diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Firat UniversityUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 10 Jul 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.
This study investigates the effects of different dietary strategies (ketogenic diet, intermittent fasting, and semi-vegetarian diet), alone or in combination with a structured home-based exercise program, on anthropometric, metabolic, and hormonal parameters in women with obesity. A total of 108 participants aged 19-45 years are allocated into nine groups, including control, exercise-only, diet-only, and combined intervention groups. Anthropometric outcomes (body weight, body mass index, and body fat percentage) and biochemical markers (glucose, insulin, adiponectin, IGF-1, irisin, and myostatin) are assessed at baseline and after a 6-week intervention period using bioelectrical impedance analysis and ELISA methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Control (C) | No intervention | –This group consists of 12 individuals with normal weight who do not receive any dietary or exercise interventions. They maintain their habitual lifestyle, physical activity, and dietary patterns for 6 weeks. |
| Obese (O) | No intervention | –This group consists of 12 individuals with obesity who do not receive any dietary or exercise interventions. They maintain their regular lifestyle, physical activity, and dietary habits for 6 weeks. |
| Obese with exercise (OE) | Experimental | Behavioral: Home-Based Exercise ProgramThis group consists of 12 individuals with obesity who participate in a structured home-based exercise program for 6 weeks, without any dietary modifications. |
| Obese with exercise plus semi-vegetarian diet (OEVD) | Experimental | Behavioral: Home-Based Exercise Program, Other: Semi-Vegetarian DietThis group consists of 12 individuals with obesity who follow a structured semi-vegetarian dietary protocol combined with a home-based exercise program for 6 weeks. |
| Obese with semi-vegetarian diet (OVD) | Experimental | Other: Semi-Vegetarian DietThis group consists of 12 individuals with obesity who follow a structured semi-vegetarian dietary protocol for 6 weeks, without participating in any exercise program. |
| Obese with exercise plus intermittent fasting (OEIF) | Experimental | Behavioral: Home-Based Exercise Program, Other: Intermittent FastingThis group consists of 12 individuals with obesity who follow a structured intermittent fasting protocol combined with a home-based exercise program for 6 weeks. |
| Obese with intermittent fasting (OIF) | Experimental | Other: Intermittent FastingThis group consists of 12 individuals with obesity who follow a structured intermittent fasting protocol for 6 weeks, without participating in any exercise program. |
| Obese with exercise plus ketogenic diet (OEKD) | Experimental | Behavioral: Home-Based Exercise Program, Other: Ketogenic DietThis group consists of 12 individuals with obesity who follow a structured ketogenic dietary protocol combined with a home-based exercise program for 6 weeks. |
| Obese with ketogenic diet (OKD) | Experimental | Other: Ketogenic DietThis group consists of 12 individuals with obesity who follow a structured ketogenic dietary protocol for 6 weeks, without participating in any exercise program. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Medically and physically fit for exercise interventions.
- No participation in any structured dietary programs within the previous 3 months.
- Lack of orthopedic limitations that would prevent safe physical activity.
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Chronic conditions such as cancer, renal failure, or hepatic failure.
- Diagnosed psychiatric disorders.
- History of adverse reactions to venipuncture.
- Inability or unwillingness to adhere to the assigned dietary and exercise intervention protocols.
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 |
|---|---|---|
| Home-Based Exercise ProgramAlso: Structured Physical ExerciseA 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement. | Behavioural | Obese with exercise (OE), Obese with exercise plus intermittent fasting (OEIF), Obese with exercise plus ketogenic diet (OEKD), Obese with exercise plus semi-vegetarian diet (OEVD) |
| Semi-Vegetarian DietAlso: Flexitarian Dietary InterventionA 6-week structured semi-vegetarian dietary protocol primarily based on plant foods with occasional inclusion of meat or fish, designed for caloric control and metabolic tracking. | Other | Obese with exercise plus semi-vegetarian diet (OEVD), Obese with semi-vegetarian diet (OVD) |
| Intermittent FastingAlso: Time-Restricted Feeding (TRF)A 6-week structured intermittent fasting protocol regulating specific eating and fasting windows each day to evaluate its effects on body composition and metabolic markers. | Other | Obese with exercise plus intermittent fasting (OEIF), Obese with intermittent fasting (OIF) |
| Ketogenic DietAlso: Very Low-Carbonhydrate Ketogenic Diet (VLCKD)A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis. | Other | Obese with exercise plus ketogenic diet (OEKD), Obese with ketogenic diet (OKD) |
Primary outcome
Change in Body Weight
Time frame: Baseline and 6 weeks
Body weight will be measured in kilograms (kg) using a calibrated Bioelectrical Impedance Analysis (BIA) device (Omron Karadascan HBF-511, Japan). The outcome will evaluate the effectiveness of the 6-week lifestyle interventions on body mass reduction compared to baseline.
9 secondary outcomes
Change in Body Mass Index (BMI)
Time frame: Baseline and week 6
Change in Body Fat Percentage
Time frame: Baseline and week 6
Change in Skeletal Muscle Percentage
Time frame: Baseline and week 6
Change in Fasting Blood Glucose
Time frame: Baseline and week 6
Change in Fasting Insulin
Time frame: Baseline and week 6
Change in Adiponectin Levels
Time frame: Baseline and week 6
Change in Insulin-Like Growth Factor 1 (IGF-1) Levels
Time frame: Baseline and week 6
Change in Irisin Levels
Time frame: Baseline and week 6
Change in Myostatin Levels
Time frame: Baseline and week 6
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 10 Jul 2026.
- Individual participant dataSharing planned: No. İndividual participant data will not be shared because participant consent for public data sharing was not obtained.
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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 Home-Based Exercise Program, Semi-Vegetarian Diet and Intermittent Fasting in people with Obesity and Metabolic Changes, run by Firat 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 3 inclusion and 5 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 10 Jul 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?
Change in Body Weight (time frame: Baseline and 6 weeks). 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 10 Jul 2026.