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Completed

NCT Number: NCT07695480

Metabolic Effects of Diet-Exercise Interventions in Obesity

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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Key information

Conditions

Obesity Behavior Body Weight Fasting Feeding Behavior Hormonal Changes Metabolic Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fırat University Hospital

Elâzığ, 23000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Structured Physical Exercise

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.

Other names: Flexitarian Dietary Intervention

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.

Other names: Time-Restricted Feeding (TRF)

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.

Other names: Very Low-Carbonhydrate Ketogenic Diet (VLCKD)

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Body Mass Index (BMI)

    Time frame: 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).

  2. Change in Body Fat Percentage

    Time frame: 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.

  3. Change in Skeletal Muscle Percentage

    Time frame: 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.

  4. Change in Fasting Blood Glucose

    Time frame: 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.

  5. Change in Fasting Insulin

    Time frame: 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.

  6. Change in Adiponectin Levels

    Time frame: 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.

  7. Change in Insulin-Like Growth Factor 1 (IGF-1) Levels

    Time frame: 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.

  8. Change in Irisin Levels

    Time frame: 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.

  9. Change in Myostatin Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

Metabolic Responses of Diet-Exercise Combinations in Women With Obesity: A Comparative Lifestyle Intervention Study With Different Diet Types

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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