Healthy DietEarly Phase 1NCT05802797
Bioavailability and Pharmacodynamics of EPA and DHA From Fortified Soymilk and Capsules
A Early Phase 1 study testing Algae Oil Fortified Soymilk and Algae Oil Capsule in people with Healthy Diet, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Diet
- What is being tested?
- Algae Oil Fortified Soymilk and Algae Oil Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to 10 Jul 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index between 18 and 30 kg/m2
Who cannot join
- Being pregnant or nursing
- Having anemia or a condition that influences the ability to donate blood safely
- Allergies to the beverage or pill ingredients
- Diabetes
- High triglycerides or cholesterol
- Coagulation disorder
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements
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.
Read the detailed description
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.
- Conditions
- Healthy Diet
- Being tested
- Algae Oil Fortified Soymilk, Algae Oil Capsule
- Keywords
- Algae Oil, EPA and DHA, Omega-3 Fatty Acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algae Oil Fortified SoymilkOther
Flavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA
Algae Oil CapsuleDietary supplement
Algae oil capsules with EPA and DHA
| Study group | Role | What they receive |
|---|---|---|
| Algae Oil Fortified Soymilk | Experimental | Subjects will drink 12 ounces of 0.4% algae oil-fortified soymilk Receives: Other: Algae Oil Fortified Soymilk |
| Algae Oil Supplements | Active comparator | Subjects will take 2 commercial algae oil capsules. Receives: Dietary Supplement: Algae Oil Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte EPA and DHA levels
Percent EPA and DHA of total fatty acids in erythrocyte samples
Measured: 4 weeks
Secondary outcomes (2)
Plasma EPA and DHA levels
Percent EPA and DHA of total fatty acids in plasma samples
Measured: 4 weeks
Peripheral blood mononuclear cell (PBMC) EPA and DHA levels
Percent EPA and DHA of total fatty acids in PBMC samples
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start3 Apr 2023
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy DietStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 24 participants (12 men and 12 women) will be randomized to two intervention groups.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yael Vodovotz, Ohio State University Comprehensive Cancer Center
- Investigators
- Yael Vodovotz, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802797
- Sponsor's protocol ID
- OSU-87
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2023
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Pharmacodynamics of Eicosapentaenoic Acid and Docosahexaenoic Acid in Soymilk and Commercial Supplements
- ClinicalTrials.gov ID
- NCT05802797
- Acronym / sponsor ID
- OSU-87
- Conditions
- Healthy Diet
- Keywords
- Algae Oil, EPA and DHA, Omega-3 Fatty Acids
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 24 participants (12 men and 12 women) will be randomized to two intervention groups.
| Arm | Type | Receives |
|---|---|---|
| Algae Oil Fortified Soymilk | Experimental | Other: Algae Oil Fortified SoymilkSubjects will drink 12 ounces of 0.4% algae oil-fortified soymilk |
| Algae Oil Supplements | Active comparator | Dietary Supplement: Algae Oil CapsuleSubjects will take 2 commercial algae oil capsules. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Body mass index between 18 and 30 kg/m2
Key exclusion criteria (11 listed)
- Being pregnant or nursing
- Having anemia or a condition that influences the ability to donate blood safely
- Allergies to the beverage or pill ingredients
- Diabetes
- High triglycerides or cholesterol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algae Oil Fortified SoymilkFlavored soymilk beverage fortified with 0.4% algae oil with both EPA and DHA | Other | Algae Oil Fortified Soymilk |
| Algae Oil CapsuleAlgae oil capsules with EPA and DHA | Dietary supplement | Algae Oil Supplements |
Primary outcome
Erythrocyte EPA and DHA levels
Time frame: 4 weeks
Percent EPA and DHA of total fatty acids in erythrocyte samples
2 secondary outcomes
Plasma EPA and DHA levels
Time frame: 4 weeks
Peripheral blood mononuclear cell (PBMC) EPA and DHA levels
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yael Vodovotz, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Algae Oil Fortified Soymilk and Algae Oil Capsule in people with Healthy Diet, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocyte EPA and DHA levels (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.