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

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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Heba Yasser Bihery, Assistant lecturer
  • Telefonnummer: 01065015529
  • E-Mail: hyasser@horus.edu.eg

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Sonstiges: 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.
Sonstiges: 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.
Sonstiges: 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.
Sonstiges: 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.
Aktiver 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
assessment of short chain free fatty acids butyrate and acetate
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
assessment of quality of life
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Horus University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juli 2026

Primärer Abschluss (Geschätzt)

10. September 2026

Studienabschluss (Geschätzt)

10. Oktober 2026

Studienanmeldedaten

Zuerst eingereicht

5. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

5. Juli 2026

Zuerst gepostet (Tatsächlich)

13. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • Heba-Phd

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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