A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Patrick Renner
- 电话号码:4242450284
学习地点
-
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Nevada
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Las Vegas、Nevada、美国、89101
- 招聘中
- Citruslabs
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Be male or female.
- Be aged 18-65.
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Omega Active Supplement
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All participants receive one dose (two capsules) of the Omega Active omega-3 supplement daily for 12 weeks.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in DHA levels in the blood
大体时间:Baseline and Week 12
|
Change from Baseline in DHA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
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Baseline and Week 12
|
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Change in EPA levels in the blood
大体时间:Baseline and Week 12
|
Change from Baseline in EPA blood concentration as assessed by blood biomarker testing (test code 92701) at Quest Diagnostics Center
|
Baseline and Week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in self-reported cognitive performance
大体时间:Baseline, Week 4, Week 8, and Week 12
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Participant-reported perceptions of the effects of the test product on cognitive function as assessed by self-reported questionnaire
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Baseline, Week 4, Week 8, and Week 12
|
|
Change in self-reported gastrointestinal symptoms
大体时间:Baseline, Week 4, Week 8, and Week 12
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Participant-reported occurrence of gastrointestinal symptoms, including acid reflux, as assessed by self-reported questionnaire
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Baseline, Week 4, Week 8, and Week 12
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Change in self-reported overall health and well-being
大体时间:Baseline, Week 4, Week 8, and Week 12
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Participant-reported perceptions of overall health and well-being as assessed by self-reported questionnaire
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Baseline, Week 4, Week 8, and Week 12
|
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Participant experience with consumption of the test product
大体时间:Baseline, Week 4, Week 8, and Week 12
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Participant-reported experience of consuming the test product, including palatability and taste, as assessed by self-reported questionnaire
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Baseline, Week 4, Week 8, and Week 12
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合作者和调查者
合作者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 20833
- legacy-20833
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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