Hormonal Changes, Metabolic Changes, Obesity
Conditions
Keywords
Adipokines, exercise therapy, fasting, IGF-1, ketogenic diet, myokines, obesity, semi-vegetarian diet
Brief 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. 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.
Interventions
BEHAVIORALHome-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
OTHERSemi-Vegetarian Diet
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.
OTHERIntermittent Fasting
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.
OTHERKetogenic Diet
A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.
Sponsors
Firat University
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Baseline and week 6 | 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). |
| Change in Body Fat Percentage | Baseline and week 6 | 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. |
| Change in Skeletal Muscle Percentage | Baseline and week 6 | 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. |
| Change in Fasting Blood Glucose | Baseline and week 6 | 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. |
| Change in Fasting Insulin | Baseline and week 6 | 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. |
| Change in Adiponectin Levels | Baseline and week 6 | 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. |
| Change in Insulin-Like Growth Factor 1 (IGF-1) Levels | Baseline and week 6 | 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. |
| Change in Irisin Levels | Baseline and week 6 | 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. |
| Change in Myostatin Levels | Baseline and week 6 | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed