Metabolic Effects of Diet-Exercise Interventions in Obesity

NCT07695480 | Completed

• 1 other identifier: FSU-OBES-DIETEX-2026-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Metabolic Changes; Hormonal Changes

Keywords

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

Outcome Measures

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.

  Baseline and 6 weeks

Secondary Outcomes (9)

• Change in Body Mass Index (BMI)

  Baseline and week 6

• Change in Body Fat Percentage

  Baseline and week 6

• Change in Skeletal Muscle Percentage

  Baseline and week 6

• Change in Fasting Blood Glucose

  Baseline and week 6

• Change in Fasting Insulin

  Baseline and week 6

Study Arms (9)

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.

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.

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.

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.

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.

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.

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.

Other: Ketogenic Diet

Interventions

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.

Also known as: Structured Physical Exercise

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 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.

Also known as: Flexitarian Dietary Intervention

Obese with exercise plus semi-vegetarian diet (OEVD); Obese with semi-vegetarian diet (OVD)

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.

Also known as: Time-Restricted Feeding (TRF)

Obese with exercise plus intermittent fasting (OEIF); Obese with intermittent fasting (OIF)

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.

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

Obese with exercise plus ketogenic diet (OEKD); Obese with ketogenic diet (OKD)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat University Hospital

Elâzığ, 23000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity; Fasting

Interventions

Diet, Ketogenic

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start: July 30, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 12, 2024
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)