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临床试验/NCT06802068
NCT06802068已完成不适用

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

Hofseth Biocare ASA4 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2025年2月18日最近更新:
适应症
干预措施

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

Active Comparator

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

Active Comparator

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

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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