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临床试验/NCT05802797
NCT05802797进行中(未招募)早期 1 期

Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements

Ohio State University Comprehensive Cancer Center2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
进行中(未招募)
入组人数
24
试验地点
2
主要终点
Erythrocyte EPA and DHA levels

研究概览

简要总结

This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools.

详细描述

Research shows that fish oil and its component fatty acids EPA and DHA provide health benefits such as reducing the risk of cardiac death and lowering inflammation. Yet a large portion of the population is not consuming the recommended amount of fish due to high cost, dietary restrictions such as vegetarianism/veganism, concerns about high levels of mercury, general dislike, and other factors. Additionally, to meet the recommendations fish and fish oil production present sustainability challenges. A potential alternative is to utilize EPA and DHA from algae. These sustainable oils can be added to foods increasing the potential for fatty acids to counteract chronic disease and increasing access to general consumers. Previously, our lab has developed, and optimized EPA and DHA fortified non-dairy plant milk beverages utilizing algae oil emulsions (food grade). Up to 0.4% algae oil can be added to soymilk with limited changes to overall liking. This study will compare the algae oil fortified soymilk to a commercial algae oil capsule containing the same base oil with the goal of demonstrating equivalent or greater accumulation of EPA and DHA in blood lipid pools. Subjects will consume either one beverage or two capsules per day, containing equivalent amounts of EPA and DHA. Blood will be taken at 4 time points throughout the 6 week study, every two weeks and analyzed for EPA and DHA in different lipid types. Additionally, participants will complete a food frequency questionnaire to evaluate their normal diet, sensory evaluation (overall liking, and attribute evaluation) of the beverages, and daily symptom and intake logs to track consumption and any side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

盲法说明

No masking.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index between 18 and 30 kg/m2

排除标准

  • Being pregnant or nursing
  • Having anemia or a condition that influences the ability to donate blood safely
  • Allergies to the beverage or pill ingredients
  • High triglycerides or cholesterol
  • Coagulation disorder
  • Anticoagulation therapy or any drug that affects blood clotting.
  • Taking prescribed dietary omega-3 fatty acid medications including fish oil or algae oil within the last 3 months
  • Taking non-prescribed dietary omega-3 fatty acid supplements within the last 3 months and not willing to discontinue taking them for the study period
  • Taking lipid lowering medications such as statins
  • Sensory impairments which affect ability to taste, smell, or see food products

结局指标

主要结局

Erythrocyte EPA and DHA levels

时间窗: 4 weeks

Percent EPA and DHA of total fatty acids in erythrocyte samples

次要结局

  • Plasma EPA and DHA levels(4 weeks)
  • Peripheral blood mononuclear cell (PBMC) EPA and DHA levels(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yael Vodovotz

Professor

Ohio State University Comprehensive Cancer Center

研究点 (2)

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