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A Clinical Trial to Evaluate the Effects of an Omega-3-containing Supplement on DHA and EPA Levels in the Blood

2026年8月3日 更新者:Revive Active

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

研究类型

介入性

注册 (估计的)

49

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Patrick Renner
  • 电话号码:4242450284

学习地点

    • Nevada
      • Las Vegas、Nevada、美国、89101
        • 招聘中
        • Citruslabs

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Omega Active Supplement
All participants receive one dose (two capsules) of the Omega Active omega-3 supplement daily for 12 weeks.

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
Baseline and Week 12
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
Participant-reported perceptions of the effects of the test product on cognitive function as assessed by self-reported questionnaire
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
Participant-reported occurrence of gastrointestinal symptoms, including acid reflux, as assessed by self-reported questionnaire
Baseline, Week 4, Week 8, and Week 12
Change in self-reported overall health and well-being
大体时间:Baseline, Week 4, Week 8, and Week 12
Participant-reported perceptions of overall health and well-being as assessed by self-reported questionnaire
Baseline, Week 4, Week 8, and Week 12
Participant experience with consumption of the test product
大体时间:Baseline, Week 4, Week 8, and Week 12
Participant-reported experience of consuming the test product, including palatability and taste, as assessed by self-reported questionnaire
Baseline, Week 4, Week 8, and Week 12

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

合作者

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月3日

首次发布 (实际的)

2026年8月7日

研究记录更新

最后更新发布 (实际的)

2026年8月7日

上次提交的符合 QC 标准的更新

2026年8月3日

最后验证

2026年8月1日

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

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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