Efficacy of OmegaBoost to Increase Omega-3 Levels Particularly Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA) in Healthy Individuals as Compared to the Leading Omega-3 Softgel and the Leading Omega-3 Gummy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Mean Changes in Omega-3 Index (OmegaQuant)
研究概览
简要总结
The purpose of this study is to determine increases in the Omega Index test indicating optimal Omega-3s particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels for overall systemic benefits including healthy cardiovascular health and cholesterol levels as shown in the OmegaIndex (OmegaQuant) research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •not currently taking Omega-3 supplements or fish oils
- •able to swallow softgel or chew gummies nutritional supplement daily for a 12 week period
- •able to make four (4) follow-up visits
排除标准
- •allergy to fish or seafood
- •h/o Atrial fibrillation, or at risk of Afib
- •h/o congestive heart failure, heart disease, or prior myocardial infarction and/or cerebrovascular accident
- •noncompliance with study requirements
结局指标
主要结局
Mean Changes in Omega-3 Index (OmegaQuant)
时间窗: Baseline, 4 weeks, 8 weeks, and 12 weeks
OmegaQuant provides Omega Index which is a percentage of omega 3 fatty acids particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the erythrocytes. The baseline values of OmegaIndex will be compared to repeated measurements obtained at at a 4-, 8- and 12-week. The OmegaQuant labs in Sioux Falls, SD analyze the blood samples to obtain omega-3 levels, omega-6 fatty acids, cis-Monounsaturated Fatty Acids, saturated fatty acids, trans fatty acids. Additionally, arachidonic acid to eicosapentaenoic acid ratio and omega 3 to omega 6 ratios will be calculated
Mean Changes in omega 3 to omega 6 ratios
时间窗: Baseline, 4 weeks, 8 weeks, and 12 weeks
The baseline values of omega 3 to omega 6 ratios provided by the blood erythrocyte testing performed the OmegaQuant test will be compared to repeated measurements obtained at a 4-, 8- and 12-week.
次要结局
- Mean changes to total cholesterol with Omega Boost supplementation(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Mean changes to low-density lipoprotein with Omega Boost supplementation(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Mean Changes in General Health Questionnaire(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Mean changes to Hb a1c with Omega Boost supplementation(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Mean changes to triglycerides with Omega Boost supplementation(Baseline, 4 weeks, 8 weeks, and 12 weeks)
- Mean changes to high-density lipoprotein with Omega Boost supplementation(Baseline, 4 weeks, 8 weeks, and 12 weeks)
研究者
Pinakin Davey
Principle Investigator
Western University of Health Sciences