A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in DHA levels in the blood
研究概览
简要总结
This is a 12-week, hybrid, single-arm clinical trial designed to evaluate the effects of an omega-3-containing supplement (Omega Active) on DHA and EPA levels in the blood. Forty participants will take two capsules of the test product daily and complete study-specific questionnaires at Baseline, Week 4, Week 8, and Week 12, while also attending their local Quest Diagnostics Center at Baseline and Week 12 for blood biomarker testing.
The study will also assess participants' perceptions of the effects of the test product on cognitive performance, gastrointestinal symptoms, and overall health through self-reported questionnaires. There is no randomization or blinding; all participants will receive the active supplement for the full 12-week intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be male or female.
- •Be aged 18-
- •Anyone in good general health.
- •Willing to avoid taking other supplements, prescription medications, or herbal remedies that target DHA or EPA levels in the body, for the duration of the study.
- •Must not have taken fish oil or plant-based omega oil supplements in the past eight weeks.
- •Willing to maintain their current diet, sleep schedule, and activity level for the duration of the study.
- •Resides in the United States.
排除标准
- •Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- •Anyone on anticoagulants or antiplatelet therapy.
- •Anyone with a bleeding disorder.
- •Anyone with any allergies or sensitivities to any of the study product ingredients.
- •Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period).
- •Anyone unwilling to follow the study protocol.
- •Anyone who does not consume any specific dietary ingredients for any reason.
- •Currently partaking in another research study or will be partaking in any other research study at any point during this study's duration.
研究组 & 干预措施
Omega Active Supplement
干预措施: Omega Active Supplement (Dietary Supplement)
结局指标
主要结局
Change in DHA levels in the blood
时间窗: Baseline and Week 12
Change from Baseline in DHA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
Change in EPA levels in the blood
时间窗: Baseline and Week 12
Change from Baseline in EPA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
次要结局
- Change in self-reported cognitive performance(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported gastrointestinal symptoms(Baseline, Week 4, Week 8, and Week 12)
- Change in self-reported overall health and well-being(Baseline, Week 4, Week 8, and Week 12)
- Participant experience with consumption of the test product(Baseline, Week 4, Week 8, and Week 12)