ACTRN12618000275268已完成3 期
A double-blind, randomised, placebo-controlled interventional study to evaluate the effect of orally-dosed Almega PL on cardio-metabolic parameters and inflammatory markers in men and women.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 25 Years 至 o limit（—）
- 性别
- All
入选标准
- •Males and females over 25 years
- •Otherwise healthy, BMI 18.5-39.9
- •Able to provide informed consent
- •Omega 6:3 ratio above 6:1
排除标准
- •Unstable or serious illness (eg kidney, liver, GIT, heart conditions and diabetes)
- •Hypercholesterolemia >7 mmol/L (193-270 mg/dL).(Will be referred to GP).
- •Malignancy or treatment for malignancy within the previous 2 years
- •Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other
- •anticoagulation therapy
- •Pregnancy or lactating women
- •Active smokers
- •Chronic past and/or current alcohol use (>14 alcoholic drinks per week)
- •Allergic to any of the ingredients in active or placebo formula
- •Serious mood disorders (such as depression and bipolar disorder) will be excluded. The
- •Hamilton Rating Scale for Depression will be used as a screening form to ensure that those
- •with undiagnosed depression are not enrolled into the study.
- •Any condition which in the opinion of the investigator makes the participant unsuitable for
- •Participants who have participated in any other clinical trial during the past month
研究者
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