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Metabolic Effects of Diet-Exercise Interventions in Obesity

8 luglio 2026 aggiornato da: Elif Subaşı, Firat University

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

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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

108

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: 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.
Nessun intervento: 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.
Sperimentale: 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.
Comportamentale: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Altri nomi:
  • Structured Physical Exercise
Sperimentale: 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.
Comportamentale: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Altri nomi:
  • Structured Physical Exercise
Altro: Semi-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.
Altri nomi:
  • Flexitarian Dietary Intervention
Sperimentale: 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.
Altro: Semi-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.
Altri nomi:
  • Flexitarian Dietary Intervention
Sperimentale: 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.
Comportamentale: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Altri nomi:
  • Structured Physical Exercise
Altro: Intermittent 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.
Altri nomi:
  • Time-Restricted Feeding (TRF)
Sperimentale: 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.
Altro: Intermittent 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.
Altri nomi:
  • Time-Restricted Feeding (TRF)
Sperimentale: 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.
Comportamentale: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Altri nomi:
  • Structured Physical Exercise
Altro: Ketogenic Diet
A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.
Altri nomi:
  • Very Low-Carbonhydrate Ketogenic Diet (VLCKD)
Sperimentale: 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.
Altro: Ketogenic Diet
A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.
Altri nomi:
  • Very Low-Carbonhydrate Ketogenic Diet (VLCKD)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Weight
Lasso di tempo: 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.
Baseline and 6 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Body Mass Index (BMI)
Lasso di tempo: 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).
Baseline and week 6
Change in Body Fat Percentage
Lasso di tempo: 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.
Baseline and week 6
Change in Skeletal Muscle Percentage
Lasso di tempo: 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.
Baseline and week 6
Change in Fasting Blood Glucose
Lasso di tempo: 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.
Baseline and week 6
Change in Fasting Insulin
Lasso di tempo: 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.
Baseline and week 6
Change in Adiponectin Levels
Lasso di tempo: 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.
Baseline and week 6
Change in Insulin-Like Growth Factor 1 (IGF-1) Levels
Lasso di tempo: 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.
Baseline and week 6
Change in Irisin Levels
Lasso di tempo: 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.
Baseline and week 6
Change in Myostatin Levels
Lasso di tempo: 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.
Baseline and week 6

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Firat University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 luglio 2023

Completamento primario (Effettivo)

15 dicembre 2023

Completamento dello studio (Effettivo)

12 gennaio 2024

Date di iscrizione allo studio

Primo inviato

1 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 luglio 2026

Primo Inserito (Effettivo)

10 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FSU-OBES-DIETEX-2026-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

İndividual participant data will not be shared because participant consent for public data sharing was not obtained.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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