A Randomised Three-way Cross Over Study to Determine the Optimal Absorption of an Omega-3 Supplement Administered as a Single Oral Dose to Healthy Volunteers
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Plasma EPA+DHA as measured by AUC0-24
研究概览
简要总结
This is a randomised three-way cross over study comparing the optimal absorption of a single dose of fish oil using 3 different forms to one another on increasing blood concentrations of fatty acids in 24 healthy adult participants aged 19 years and over.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and females over 19 years and otherwise healthy
- •Healthy BMI >18.0 and <30.0
- •Able to provide informed consent
- •Agree to arrive fasted on the day of the trial
- •Agree to participate in all arms of the study
排除标准
- •Unstable or serious illness [e.g. kidney, liver (including NAFLD), GIT, heart conditions, diabetes, thyroid gland function malignancy]*
- •Any treatment that included radiation or chemotherapy within the previous 2 years
- •Receiving/prescribed coumandin (Warfarin), heparin, daltaparin, enoxaparin or other anticoagulation therapy.
- •Regular use of supplements containing the investigational material (e.g. Omega-3 fatty acids), in the last 3 months, regular consumption of foods containing the investigational material (e.g. fish for omega-3) #
- •Active smokers, nicotine, alcohol, drug abuse
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients (i.e., fish oil)
- •Pregnant or lactating women
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •Regular use or consumption is considered if participants are consuming omega containing supplements or foods on 3 or more days per week.
研究组 & 干预措施
Product 1 - AquaCelle Fish Oil Triglyceride
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.4g AquaCelle The dose will be consumed orally with 250 mL water.
干预措施: Product 1 - AquaCelle Fish Oil Triglyceride (Drug)
Product 2 - AquaCelle Fish Oil Ethyl Ester
1 dose of 2 capsules equivalent to 1.6g Fish Oil Ethyl Ester (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)) and 0.28g AquaCelle The dose will be consumed orally with 250 mL water.
干预措施: Product 2 - AquaCelle Fish Oil Ethyl Ester (Drug)
Product 3 - Standard Fish Oil Triglyceride
1 dose of 2 capsules equivalent to 1.6g Fish Oil Triglyceride (standardised to contain 1120 mg of eicosapentaenoic acid and docosahexaenoic acid (EPA+DHA)).
The dose will be consumed orally with 250 mL water.
干预措施: Product 3 - Standard Fish Oil Triglyceride (Drug)
结局指标
主要结局
Plasma EPA+DHA as measured by AUC0-24
时间窗: 0, 2, 4, 6, 8, 10, 12 and 24 hours post ingestion
Change in plasma EPA+DHA from baseline as measured by AUC0-24
次要结局
- Tmax(24 hours post ingestion)
- Cmax(24 hours post ingestion)