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Metabolic Effects of Diet-Exercise Interventions in Obesity

8. juli 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

108

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: 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.
Ingen indgriben: 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.
Eksperimentel: 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.
Adfærdsmæssigt: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Andre navne:
  • Structured Physical Exercise
Eksperimentel: 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.
Adfærdsmæssigt: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Andre navne:
  • Structured Physical Exercise
Andet: 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.
Andre navne:
  • Flexitarian Dietary Intervention
Eksperimentel: 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.
Andet: 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.
Andre navne:
  • Flexitarian Dietary Intervention
Eksperimentel: 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.
Adfærdsmæssigt: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Andre navne:
  • Structured Physical Exercise
Andet: 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.
Andre navne:
  • Time-Restricted Feeding (TRF)
Eksperimentel: 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.
Andet: 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.
Andre navne:
  • Time-Restricted Feeding (TRF)
Eksperimentel: 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.
Adfærdsmæssigt: Home-Based Exercise Program
A 6-week structured home-based exercise program consisting of moderate-intensity activities designed for weight management and metabolic improvement.
Andre navne:
  • Structured Physical Exercise
Andet: Ketogenic Diet
A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.
Andre navne:
  • Very Low-Carbonhydrate Ketogenic Diet (VLCKD)
Eksperimentel: 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.
Andet: Ketogenic Diet
A 6-week structured ketogenic dietary protocol characterized by high-fat, adequate-protein, and very low-carbohydrate intake to induce nutritional ketosis.
Andre navne:
  • Very Low-Carbonhydrate Ketogenic Diet (VLCKD)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Weight
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Body Mass Index (BMI)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Firat University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. juli 2023

Primær færdiggørelse (Faktiske)

15. december 2023

Studieafslutning (Faktiske)

12. januar 2024

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FSU-OBES-DIETEX-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Placeringer

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