Flaxseed Oil, Olive Oil, and Their Combination on Hepatic and Metabolic Outcomes in Patients With Metabolic Dysfunction-Associated Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
T0. Control group
Conventional diet+treatment
干预措施: Conventional diet+treatment (Dietary Supplement)
T2: extra virgin olive oil
Conventional diet+ treatment + extra virgin olive oil (22.5ml/day)
干预措施: extra virgin olive oil (Dietary Supplement)
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)
干预措施: Flaxssed oil and extra virgin olive oil (Dietary Supplement)
T1: flaxseed oil
Conventional diet+ treatment + flaxseed oil (22.5ml/day)
干预措施: flaxseed oil (Dietary Supplement)
结局指标
主要结局
Body Mass Index
时间窗: 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.
Glycated Hemoglobin Levels
时间窗: 16 WEEKS
Glycated hemoglobin (HbA1c) reflects the average blood glucose level over the previous 2-3 months and is reported as a percentage (%)
Cytokeratin-18 (CK-18) Analysis
时间窗: 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.
Liver Enzymes
时间窗: 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.
次要结局
- lIPID PROFILE(16 WEEKS)