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

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

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Heba Yasser Bihery, Assistant lecturer
  • Número de teléfono: 01065015529
  • Correo electrónico: hyasser@horus.edu.eg

Ubicaciones de estudio

  • Egipto
      • Cairo, Egipto
        • out-patient clinic, faculty of physical therapy, Horus university
        • Contacto:
          • Heba Yasser Bihery, Assistant lecturer
          • Número de teléfono: 01065015529
          • Correo electrónico: hyasser@horus.edu.eg

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Otro: 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.
Otro: 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.
Experimental: 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.
Otro: 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.
Otro: 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.
Comparador activo: 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.
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
assessment of short chain free fatty acids butyrate and acetate
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
assessment of quality of life
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Horus University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

10 de julio de 2026

Finalización primaria (Estimado)

10 de septiembre de 2026

Finalización del estudio (Estimado)

10 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

5 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de julio de 2026

Publicado por primera vez (Actual)

13 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • Heba-Phd

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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