Flaxseed Oil, Olive Oil, and Their Combination on Hepatic and Metabolic Outcomes in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
This 16-week randomized controlled trial evaluated the effects of flaxseed oil, extra virgin olive oil, and their combination on biochemical hepatic and metabolic outcomes in patients with MAFLD.
The study assessed CK-18 as the primary outcome, with BMI, HbA1c, liver enzymes, and lipid profile as secondary outcom
調査の概要
状態
詳細な説明
This 16-week, four-arm randomized controlled trial involving 112 patients with MAFLD evaluated the effects of flaxseed oil, extra virgin olive oil, and their combined supplementation compared with a control group.
The study primarily assessed serum CK-18, with BMI, HbA1c, liver enzymes, and lipid profile as secondary biochemical and metabolic outcomes to evaluate the potential benefits of these dietary oils.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Punjab Province
-
Lahore、Punjab Province、パキスタン、54000
- Sana Noreen
-
-
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:
- Participants aged 45-65 years, with a confirmed diagnosis of metabolic dysfunction-associated fatty liver disease (MAFLD),
- a body mass index (BMI) ≥25 kg/m²,
- HbA1c ≥5.7%,
- elevated serum cytokeratin-18 (CK-18)
Exclusion Criteria:
- Participants who had initiated or changed hypoglycemic, lipid-lowering, antihypertensive, hepatoprotective, corticosteroid, or weight-loss medications within the three months preceding enrollment were excluded,
- Pregnant or lactating women, individuals with known allergies or hypersensitivity to flaxseed, olive oil, or other herbal products used in the intervention,
- participants with severe hepatic, renal, cardiovascular, or other systemic diseases that could interfere with the study outcomes
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：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：T0. Control group
Conventional diet+treatment |
Conventional diet+treatment |
|
実験的：T1: flaxseed oil
Conventional diet+ treatment + flaxseed oil (22.5ml/day) |
Conventional diet+ treatment + flaxseed oil (22.5ml/day) |
|
実験的：T2: extra virgin olive oil
Conventional diet+ treatment + extra virgin olive oil (22.5ml/day) |
Conventional diet+ treatment + extra virgin olive oil (22.5ml/day) |
|
実験的：T3: extra virgin olive oil + flaxseed oil
Conventional diet+ treatment + combined extra virgin olive oil (22.5 ml/day) plus flaxseed oil (22.5 ml/day) |
Conventional diet+ treatment + combined extra virgin olive oil (22.5 ml/day) plus flaxseed oil (22.5 ml/day) |
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 |
|---|---|---|
|
Body Mass Index
時間枠：16 WEEKS
|
BMI (Body Mass Index) is a measure of body weight relative to height, calculated as weight (kg) ÷ height² (m²) and expressed in kg/m². |
16 WEEKS
|
|
Glycated Hemoglobin Levels
時間枠：16 WEEKS
|
Glycated hemoglobin (HbA1c) reflects the average blood glucose level over the previous 2-3 months and is reported as a percentage (%) |
16 WEEKS
|
|
Cytokeratin-18 (CK-18) Analysis
時間枠：16 WEEKS
|
Cytokeratin-18 (CK-18) is a biomarker of hepatocyte apoptosis and liver injury, commonly measured in serum and reported according to the specific assay used. |
16 WEEKS
|
|
Liver Enzymes
時間枠：16 weeks
|
Liver enzymes are blood biomarkers used to assess liver injury and function, commonly including ALT, AST, ALP, and GGT, reported in U/L. |
16 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
lIPID PROFILE
時間枠：16 WEEKS
|
Lipid profile measures blood lipids, including total cholesterol (TC), triglycerides (TG), LDL-C, and HDL-C, which are important indicators of cardiovascular and metabolic health.mg/dL |
16 WEEKS
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：sana noreen、University of Lahore
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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