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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Exercise Program | Behavioral | A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline and week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fırat University Hospital | Elâzığ | 23000 | Turkey (Türkiye) |
Ä°ndividual participant data will not be shared because participant consent for public data sharing was not obtained.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 12, 2023 | Jul 1, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 12, 2023 | Jul 1, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2023 | Jul 1, 2026 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055423 | Diet, Ketogenic |
| ID | Term |
|---|---|
| D050528 | Diet, Carbohydrate-Restricted |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Semi-Vegetarian Diet | Other | 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. |
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| Intermittent Fasting | Other | 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. |
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| Ketogenic Diet | Other | A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis. |
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| 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline and week 6 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |