Diet and Physical Activity on NAFLD and Erytrocyte Membrane Lipid Profile.
Effect of Two Programs of Physical Activity of Different Intensity, Mediterranean Diet and the Combination of Both on NAFLD and Erytrocyte Membrane Lipid Profile.
調査の概要
状態
条件
詳細な説明
The surveys conducted on the populations of Castellana Grotte and Putignano (Bari, Italy) evidenced that Non-Alcoholic Fatty liver Disease (NAFLD) reaches a prevalence of 30%, especially among aged and male individuals. Being a crucial outcome of several metabolic alterations, it becomes imperative for Public Health to adopt strategies aimed to control the factors responsible for NAFLD onset.
The objective of this study is to evaluate the effect of two programs of different intensity level of physical activity, of low glycemic index Mediterranean Diet and of the interaction of both, on NAFLD score and on the lipid composition of the erythrocyte membrane.
Study participants responding to the inclusion criteria of this trial will be chosen both in the hospital setting and in the general practitioners' clinics. At the enrollement, anthropometric and biochemical variables will be measured, as well as bioimpedenziometric and calorimetric parameters; participants will also undergo Fibroscan-CAP to measure the outcome and will be asked about their medical history and life-style. Subjects will be randomized to the different arms of the trial and be followed-up at the end of the sixth and the twelfth week of enrollement.
All data will be statistically analysed by applying the Chi-Square test and t-test for discrete and continuous variables, respectively. As it deals with the analysis of data repeatedly measured on the same subject, the Generalized Estimating Equation (GEE) will be applied to evaluate the effect of the intervention on the outcomes.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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BA
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Castellana Grotte、BA、イタリア、70013
- 募集
- Laboratory of Epidemiology and Biostatistics-IRCCS Saverio de Bellis
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コンタクト：
- Isabella Franco, BSc
- 電話番号：00390804994650
- メール：isabella.franco@irccsdebellis.it
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- BMI ≥ 25.0
- Moderate or severe NAFLD
- 30 < age <60
Exclusion Criteria:
- Overt cardiovascular disease and revascularization procedures;
- Stroke;
- Clinical peripheral artery disease;
- Type-2 Diabetes Mellitus (current treatment with insulin or oral hypoglycemic drugs, fasting glucose >126 mg/dl, or casual glucose >200 mg/dl);
- Severe medical condition that may impair the person to participate in a nutritional intervention study;
- Impossibility to follow Mediterranean Diet for religious or other reasons.
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Control
The subjects will follow a diet based on INRAN guidelines without doing any physical activity.
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Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
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他の：LGIMD
The subjects will follow a Low Glycemic Index Mediterranean Diet without doing any physical activity.
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Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
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他の：Endurance Activity (EA)
The subjects will follow a program of endurance (aerobic) activity (EA) without following a specific diet.
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Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity:
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他の：EA+Resistance Training (RT)
The subjects will follow a program of endurance activity (EA) and resistance training (RT) without following a specific diet.
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Subject will follow a program of endurance activity as follows: Frequency: 3 times/week Duration: 60 minutes Intensity (for Endurance activity):
Resistance activity: Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs);
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他の：LGIMD+EA
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA).
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Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
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他の：LGIMD+EA/RT
The subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) togheter with a program of endurance activity (EA) and resistance training (RT).
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Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
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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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Non-Alcoholic Fatty liver Disease (NAFLD) score
時間枠：up to 12 weeks
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NAFLD score will be built with Fobroscan-CAP
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up to 12 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Lipid composition of erythrocyte membrane
時間枠：6 and 12 weeks
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6 and 12 weeks
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Sierical lipid profile
時間枠：6 and 12 weeks
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6 and 12 weeks
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協力者と研究者
捜査官
- 主任研究者：Alberto R Osella, MD, PhD、IRCCS "Saverio de Bellis"
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- NUTRIATT
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。