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High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver

5 lipca 2026 zaktualizowane przez: Heba Yasser, Horus University
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

non- Alcoholic Fatty Liver disease affects approximately 25% of the global population, with its prevalence increasing due to lifestyle changes such as poor diet and sedentary behavior. non- Alcoholic Fatty Liver disease is often associated with metabolic disorders, including insulin resistance, obesity, and type 2 diabetes. Emerging evidence suggests that alterations in gut microbiota may contribute to the pathophysiology of non- Alcoholic Fatty Liver disease, influencing liver function, inflammation, and metabolic regulation. However, there is limited research exploring the effects of interventions such as exercise and dietary changes on gut microbiota composition in non- Alcoholic Fatty Liver disease patients The findings of this study could have important clinical implications, particularly for developing tailored lifestyle interventions for non- Alcoholic Fatty Liver disease patients. As gut microbiota dysbiosis is increasingly recognized as a key player in the development and progression of non- Alcoholic Fatty Liver disease, interventions targeting microbiota balance could offer novel therapeutic approaches for managing this prevalent and potentially severe condition

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Heba Yasser Bihery, Assistant lecturer
  • Numer telefonu: 01065015529
  • E-mail: hyasser@horus.edu.eg

Lokalizacje studiów

  • Egipt
      • Cairo, Egipt
        • out-patient clinic, faculty of physical therapy, Horus university
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  1. Patients from both genders aged 40 - 60 years old diagnosed with Non-alcoholic Fatty Liver disease by ultrasonography.
  2. Body mass index will range from 30 to 34.9 kg/m².
  3. Patients with central obesity (waist circumference 90 cm for men and 85 cm for women).
  4. Patients who have taken no regular exercise in the last year (<3 times/week and 30 min/time.
  5. No antibiotic or probiotic use for at least last 3 months.
  6. Medical drugs such as metformin, sulfonylureas, statins, and blood pressure medication were eligible, as well as stable.

Exclusion Criteria:

  1. History of liver cirrhosis or other chronic liver diseases.
  2. Use of medications affecting gut microbiota (e.g., laxatives, metformin, proton pump inhibitors).
  3. Recent gastrointestinal infections or surgeries.
  4. Diabetes Mellitus type 1 or uncontrolled type 2.
  5. Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
  6. Active smokers.
  7. Pregnancy or breastfeeding.
  8. Uncontrolled hypertension.
  9. Communication disorders.
  10. Bleeding disorders.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: high intensity interval training and Mediterranean diet
This study will involve 20 patients with Non-alcoholic Fatty Liver disease undergoing individualized High-Intensity Interval Training for 12 weeks. The exercise regimen includes 3 sessions per week, featuring 3 sets of 3 minutes of high-intensity intervals at 70-90% heart rate reserve, with 2 minutes of active recovery between intervals. All exercise will be supervised on a treadmill, complemented by a Mediterranean diet.
Inny: High intensity interval training
Patients will engage in high-intensity interval training using heart rate reserve (HRR) to determine exercise intensity. The program includes three sessions per week for 12 weeks, featuring three 3-minute high-intensity intervals at 70-90% HRR, with 2 minutes of active recovery in between. Each 30-minute session will be treadmill-based under supervision, incorporating warm-up and cool-down periods. Participants will also follow a Mediterranean diet.
Inny: Mediterranean diet
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%). Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%. Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.
Eksperymentalny: moderate intensity continous training and Mediterranean diet
This group will include 20 patients with non-alcoholic Fatty Liver disease they will receive moderate intensity continous training protocol consisted of 3× 3 min of moderate -intensity intervals at 40- 60% heart rate reserve for 30 min, in addition to Mediterranean diet.
Inny: Mediterranean diet
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%). Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%. Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.
Inny: moderate intensity continuous training

The program will be in form of:

  • Frequency: 3 sessions/week for 12 weeks.
  • Intensity: Moderate intensity continues training at 40- 60% HRR.
  • Duration: the session will last 30 minutes per session. Patients will be instructed to follow Mediterranean Diet.
Aktywny komparator: Mediterranean Diet
It is characterized by a high consumption of plant-based foods, such as vegetables, fruits, whole grains, seeds, nuts and legumes, and moderate consumption of protein-source foods such as fish and poultry. This diet is rich in monounsaturated fatty acids primarily from olive oil and olives, reduced fat dairy products and low red meat intake.
Inny: Mediterranean diet
the composition of the Mediterranean diet, emphasizing that vegetables and fruits make up the largest portion at 35%, followed by whole grains (20%) and fish and seafood (15%). Legumes and nuts account for 10%, while olive oil and dairy products (cheese and yogurt) each contribute 7%. Smaller portions include poultry and eggs (4%) and red meat and sweets (2%), reflecting the diet's focus on plant-based foods, healthy fats, whole grains, and moderate consumption of animal products, with minimal intake of red meat and sugary foods.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
assessment of short chain free fatty acids butyrate and acetate
Ramy czasowe: at baseline and after 12 weeks
For short chain free fatty acids analyses, fecal sample will be separated. Applying four analytes, including total Short Chain Fatty Acids, acetate, propionate, and butyrate, will be targeted. Final concentrations will be calculated based on internal standards and are expressed as micromoles per gram of wet feces (μmol/g). Techniques and predictive approaches will be used across. gas chromatography will be used to quantify Short Chain Fatty Acids from fecal samples
at baseline and after 12 weeks
assessment of lipid profile
Ramy czasowe: at baseline and after 12 weeks
Fasting blood samples were collected after an overnight fast, and serum lipid levels were analyzed using standard enzymatic methods with an automated biochemical analyzer. The lipid profile included triglycerides, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol to assess lipid metabolism and cardiovascular risk.
at baseline and after 12 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
assessment of quality of life
Ramy czasowe: at baseline and after 12 weeks
The short form-12 was scored using the standard scoring algorithm, which converts participants' responses into two norm-based summary measures: the Physical Component Summary and the Mental Component Summary. Each score ranges from 0 to 100, with higher scores indicating better health-related quality of life. The scores were calculated according to the official short form -12 scoring guidelines.
at baseline and after 12 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Horus University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

10 lipca 2026

Zakończenie podstawowe (Szacowany)

10 września 2026

Ukończenie studiów (Szacowany)

10 października 2026

Daty rejestracji na studia

Pierwszy przesłany

5 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 lipca 2026

Pierwszy wysłany (Rzeczywisty)

13 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

5 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • Heba-Phd

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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