High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver
2026년 7월 5일 업데이트: Heba Yasser, Horus University
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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
연구 유형
연구 유형
중재적
등록 (추정된)
등록
60
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Heba Yasser Bihery, Assistant lecturer
- 전화번호: 01065015529
- 이메일: hyasser@horus.edu.eg
연구 장소
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Cairo, 이집트
- out-patient clinic, faculty of physical therapy, Horus university
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연락하다:
- Heba Yasser Bihery, Assistant lecturer
- 전화번호: 01065015529
- 이메일: hyasser@horus.edu.eg
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Patients from both genders aged 40 - 60 years old diagnosed with Non-alcoholic Fatty Liver disease by ultrasonography.
- Body mass index will range from 30 to 34.9 kg/m².
- Patients with central obesity (waist circumference 90 cm for men and 85 cm for women).
- Patients who have taken no regular exercise in the last year (<3 times/week and 30 min/time.
- No antibiotic or probiotic use for at least last 3 months.
- Medical drugs such as metformin, sulfonylureas, statins, and blood pressure medication were eligible, as well as stable.
Exclusion Criteria:
- History of liver cirrhosis or other chronic liver diseases.
- Use of medications affecting gut microbiota (e.g., laxatives, metformin, proton pump inhibitors).
- Recent gastrointestinal infections or surgeries.
- Diabetes Mellitus type 1 or uncontrolled type 2.
- Cardiovascular, respiratory, or musculoskeletal disorders limiting exercise capacity.
- Active smokers.
- Pregnancy or breastfeeding.
- Uncontrolled hypertension.
- Communication disorders.
- Bleeding disorders.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
3
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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.
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실험적: 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.
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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.
The program will be in form of:
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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assessment of short chain free fatty acids butyrate and acetate
기간: at baseline and after 12 weeks
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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
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at baseline and after 12 weeks
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assessment of lipid profile
기간: at baseline and after 12 weeks
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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.
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at baseline and after 12 weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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assessment of quality of life
기간: at baseline and after 12 weeks
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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.
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at baseline and after 12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 7월 10일
기본 완료 (추정된)
기본 완료
2026년 9월 10일
연구 완료 (추정된)
연구 완료
2026년 10월 10일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 5일
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처음 게시됨 (실제)
처음 게시됨
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
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마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- Heba-Phd
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .