High-intensity Interval Training Versus Moderate Intensity Continuous Training on Gut Microbiota in Non-alcoholic Fatty Liver
2026年7月5日 更新者：Heba Yasser、Horus University
To compare High-Intensity Interval Training versus moderate intensity continuous training on gut microbiota in Non- Alcoholic Fatty Liver.
調査の概要
状態
まだ募集していません
条件
詳細な説明
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
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Heba Yasser Bihery, Assistant lecturer
- 電話番号：01065015529
- メール：hyasser@horus.edu.eg
研究場所
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Cairo、エジプト
- out-patient clinic, faculty of physical therapy, Horus university
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コンタクト：
- Heba Yasser Bihery, Assistant lecturer
- 電話番号：01065015529
- メール：hyasser@horus.edu.eg
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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assessment of short chain free fatty acids butyrate and acetate
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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assessment of quality of life
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月10日
一次修了 (推定)
2026年9月10日
研究の完了 (推定)
2026年10月10日
試験登録日
最初に提出
2026年7月5日
QC基準を満たした最初の提出物
2026年7月5日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月5日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。