ClinicalTrials.gg
CompletedNCT07695480Updated Jul 10, 2026

Metabolic Effects of Diet-Exercise Interventions in Obesity

An interventional study of Home-Based Exercise Program and Semi-Vegetarian Diet in Obesity, Metabolic Changes and Hormonal Changes, sponsored by Firat University. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 19 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Firat University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jul 2023, registered Jul 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Non-randomized
Ages
19 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Obesity
  • Metabolic Changes
  • Hormonal Changes

Browse trials for

Keywords

  • Adipokines
  • exercise therapy
  • fasting
  • IGF-1
  • ketogenic diet
  • myokines
  • obesity
  • semi-vegetarian diet
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 108 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Firat University is the lead sponsor of 117 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
108 participants (actual)

Study arms

  • No intervention
    Control (C)

    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.

  • No intervention
    Obese (O)

    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.

  • Experimental
    Obese with exercise (OE)

    This group consists of 12 individuals with obesity who participate in a structured home-based exercise program for 6 weeks, without any dietary modifications.

    Behavioral: Home-Based Exercise Program

  • Experimental
    Obese with exercise plus semi-vegetarian diet (OEVD)

    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.

    Behavioral: Home-Based Exercise Program · Other: Semi-Vegetarian Diet

  • Experimental
    Obese with semi-vegetarian diet (OVD)

    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.

    Other: Semi-Vegetarian Diet

  • Experimental
    Obese with exercise plus intermittent fasting (OEIF)

    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.

    Behavioral: Home-Based Exercise Program · Other: Intermittent Fasting

  • Experimental
    Obese with intermittent fasting (OIF)

    This group consists of 12 individuals with obesity who follow a structured intermittent fasting protocol for 6 weeks, without participating in any exercise program.

    Other: Intermittent Fasting

  • Experimental
    Obese with exercise plus ketogenic diet (OEKD)

    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.

    Behavioral: Home-Based Exercise Program · Other: Ketogenic Diet

  • Experimental
    Obese with ketogenic diet (OKD)

    This group consists of 12 individuals with obesity who follow a structured ketogenic dietary protocol for 6 weeks, without participating in any exercise program.

    Other: Ketogenic Diet

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.

    Also known as: Structured Physical Exercise

  • 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.

    Also known as: Flexitarian Dietary Intervention

  • 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.

    Also known as: Time-Restricted Feeding (TRF)

  • OtherKetogenic Diet

    A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.

    Also known as: Very Low-Carbonhydrate Ketogenic Diet (VLCKD)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and 6 weeks

Secondary outcomes

  1. 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).

    Time frame: Baseline and week 6

  2. 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.

    Time frame: Baseline and week 6

  3. 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.

    Time frame: Baseline and week 6

  4. 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.

    Time frame: Baseline and week 6

  5. 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.

    Time frame: Baseline and week 6

  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.

    Time frame: Baseline and week 6

  7. 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.

    Time frame: Baseline and week 6

  8. 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.

    Time frame: Baseline and week 6

  9. 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.

    Time frame: Baseline and week 6

07

Study locations

1 site
  • Fırat University Hospital
    Elâzığ, 23000, Turkey (Türkiye)
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — İndividual participant data will not be shared because participant consent for public data sharing was not obtained.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07695480
Lead sponsor
Firat University
Responsible party
Elif Subaşı (PhD Student, Firat University) — Principal investigator
First posted
Jul 10, 2026
Start date
Jul 30, 2023
Primary completion
Dec 15, 2023
Completion
Jan 12, 2024
Last update
Jul 10, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion