A Randomized Controlled Clinical Trial Assessing the Impact of 14-week Natural Salmon Oil Supplementation (CARDIO®) on the Omega-3 Index Response and Cardiometabolic and Inflammatory Biomarkers in Healthy, Non-Pregnant Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement
研究概览
简要总结
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on inflammation and oxidative stress, cholesterol and markers of risk of diabetes. Change in sleep metrics will also be assessed.
详细描述
Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits akin to eating fresh fish. This could be because contains many more fats than just EPA and DHA and these other fats have well defined health benefits such as oleic acid which is also abundant in olive oil. Alternatively this might be a result of significant processing needed to extract and concentrate the omega-3 fraction resulting in elevated levels of oxidation and free fatty acids, both of which are pro-inflammatory and would therefore impair the health benefits of omega-3. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on common drivers of inflammation and oxidative stress, blood cholesterol and markers of the risk of developing diabetes. Change in sleep metrics will also be assessed using both questionnaires and data from the hypnograms recorded by wearable device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, non-pregnant adults; 40-80 years of age; stable body weight prior 3 months
排除标准
- •Fish or seafood allergies; Pregnant; already consuming fish oil supplementation; malabsorption states; malignancy in remission for less than 12 months; diabetic
研究组 & 干预措施
CARDIO salmon oil soft gel capsules
A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon
干预措施: whole salmon oil (Dietary Supplement)
Omega-3 cod liver oil soft gel capsules
A standard, processed, concentrated omega-3 supplement
干预措施: Cod liver oil (Dietary Supplement)
结局指标
主要结局
To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement
时间窗: 18 weeks
Change in omega-3 index after 14 weeks supplementation
次要结局
未报告次要终点
