CTRI/2025/08/093737尚未招募不适用
Effect of flaxseed supplementation in Metabolic dysfunction associated steatotic liver disease- a randomised control trial
AIIMS delhi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess improvement in liver steatosis in terms of Fibroscan CAP value
研究概览
简要总结
This study aims to assess the efficacy of flax seed supplementation in Metabolic dysfunction associated steatotic liver disease in terms of liver steatosis (fibroscan CAP VALUE),metabolic and anthropometric parameters. A total of 60 participants will be divided into two group.The intervention group will receive 30 g of flaxseed daily for a period of 12 weeks along with standard of care and control group will receive standard of care treatment.The result of the study will help in assessing whether flaxseed supplementation can be used an adjunct to standard of care treatment for MASLD in future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •MASLD diagnosed on fibroscan or abdominal ultrasound At least one of cardiometabolic criteria: 1.BMI more than or equal to 25 kg/m2 2.FBS more than or equal to 140 mg/dl or Hba1C more than or equal to 5.7 % or on treatment for type 2 diabetes mellitus
- •BP more than or equal to 130/85 or on antihypertensive treatment.
- •4.Plasma triglyceride more than or equal to 150 mg/dl or on lip[id lowering agents.
- •5.Plasma HDL less than.
- •40 mg.dl in males or less than 50 gm/dl in females.
排除标准
- •Alcohol consumption more than 20 g/day in females and more than 40 g/day in males.
- •Intake of drugs causing liver steatosis like amiodarone,methotrexate etc.
- •Hepatitis C or Hepatitis B Pregnancy or lactation Allergy to flaxseeds Malabsorption syndromes Hypothyroidism.
结局指标
主要结局
To assess improvement in liver steatosis in terms of Fibroscan CAP value
时间窗: At the end of 12 weeks
次要结局
- To assess changes in anthropometric and metabolic parameters like FBS , lipid profile(At the end of 12 weeks)
研究者
Dr Meenakshi Babu
AIIMS,New Delhi
研究点 (1)
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