EPA/DHA Supplements for Healthy Eating

Overseen By Abigail Sommer, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Anticoagulants, Omega-3s, Statins

Disqualifiers: Pregnancy, Anemia, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if drinking algae oil-fortified soymilk can boost omega-3 levels in the blood as effectively as taking algae oil capsules. Omega-3s, such as EPA and DHA, are vital for heart and brain health. Participants will either drink the soymilk or take the capsules, and researchers will compare the results. Individuals who are not pregnant, have no allergies to the products, and are not taking omega-3 supplements or certain medications may be suitable candidates. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires that you stop taking any prescribed or non-prescribed omega-3 supplements, like fish oil or algae oil, for the study period. If you are on anticoagulation therapy or medications that affect blood clotting, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that algal oil, like that used in both the capsules and fortified soymilk, is safe for consumption. Research indicates that algal oil, rich in omega-3 fatty acids such as DHA and EPA, has been used safely for up to four years. Most people tolerate it well, though some may experience mild side effects like a fishy aftertaste or minor digestive issues. Overall, it is considered safe when consumed as part of food or taken as supplements. This suggests that both the algae oil capsules and the fortified soymilk in this study are likely to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they use algae oil, a plant-based source of omega-3 fatty acids EPA and DHA, which are usually derived from fish. Unlike traditional omega-3 supplements, which often come in capsule form, one of these treatments is incorporated into soymilk, offering a unique and convenient way to consume these beneficial nutrients. This approach not only provides an alternative for those who prefer not to take pills but also for individuals seeking vegetarian or vegan options. The algae oil used in both the capsules and fortified soymilk could also reduce the fishy aftertaste associated with conventional fish oil supplements, making it more appealing to a broader audience.

What evidence suggests that this trial's treatments could be effective for increasing EPA and DHA levels?

Research has shown that algae oil capsules, one of the treatments in this trial, serve as an excellent alternative to fish oil for increasing DHA levels, particularly for vegetarians and vegans. Studies have found that these capsules significantly boost DHA in the blood, improving heart health by raising good cholesterol (HDL-C) and possibly lowering triglycerides, a type of fat in the blood. Another treatment in this trial involves adding algae oil to plant-based milk, such as soy milk, to increase omega-3 intake, which is crucial for maintaining health and preventing disease. Both methods in this trial aim to increase essential fats like EPA and DHA in the body, supporting overall wellness. ^{6 7 8 9 10}

Who Is on the Research Team?

Yael Vodovotz, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults with a BMI between 18 and 30 who are not pregnant or nursing, don't have anemia, high cholesterol/triglycerides, coagulation disorders, diabetes, allergies to ingredients in the test products, and haven't taken omega-3 supplements or certain medications recently.

Inclusion Criteria

Body mass index between 18 and 30 kg/m2

Exclusion Criteria

I am on medication that affects blood clotting.

Being pregnant or nursing

Allergies to the beverage or pill ingredients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either algae oil fortified soymilk or commercial algae oil capsules for 6 weeks

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Algae Oil Capsule
• Algae Oil Fortified Soymilk

Trial Overview The study aims to compare how well the body absorbs EPA and DHA (healthy fats) from algae oil fortified soymilk versus standard algae oil capsules. It will measure the levels of these fats in participants' blood over time.

How Is the Trial Designed?

Group I: Algae Oil Fortified Soymilk Experimental Treatment 1 Intervention

Subjects will drink 12 ounces of 0.4% algae oil-fortified soymilk

Group II: Algae Oil Supplements Active Control 1 Intervention

Subjects will take 2 commercial algae oil capsules.

Algae Oil Capsule is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Algal Oil for:

• Cardiovascular health
• Brain health
• Eye health

Approved in United States as Algal Oil for:

• Heart health
• Brain function
• Eye health

Approved in Canada as Algal Oil for:

• Cardiovascular health
• Cognitive function
• Eye health

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

A study on preweaning farm piglets showed that both DHASCO-B and DHASCO, two DHA-rich oils, were well tolerated with no adverse effects on growth, development, or clinical health over a 3-week period.

The bioequivalence of DHASCO-B to DHASCO was confirmed, indicating that both oils provide similar benefits in terms of DHA accumulation in the body, making DHASCO-B a suitable alternative for infant formulas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 3-week dietary bioequivalence study in preweaning farm piglets of two sources of docosahexaenoic acid produced from two different organisms. Fedorova-Dahms, I., Thorsrud, BA., Bailey, E., et al.[2014]

DHA-rich algal oil ONC-T18 showed no mutagenic or genotoxic potential in various tests, indicating it is safe for consumption.

In a 90-day study with rats, even at high concentrations (up to 50,000 ppm), the algal oil did not cause any significant toxic effects, establishing a no observed adverse effect level (NOAEL) at this highest dosage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicologic evaluation of DHA-rich algal oil: Genotoxicity, acute and subchronic toxicity in rats. Schmitt, D., Tran, N., Peach, J., et al.[2012]

Almega®PL, an EPA-only supplement derived from microalgae, significantly increased the Omega-3 Index and EPA levels in healthy individuals after 12 weeks of daily use, compared to a placebo group.

The supplementation led to a 25% reduction in very-low-density lipoprotein (VLDL) cholesterol without increasing low-density lipoprotein (LDL) levels, suggesting a beneficial effect on cholesterol management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omega-3 Eicosapentaenoic Acid (EPA) Rich Extract from the Microalga Nannochloropsis Decreases Cholesterol in Healthy Individuals: A Double-Blind, Randomized, Placebo-Controlled, Three-Month Supplementation Study. Rao, A., Briskey, D., Nalley, JO., et al.[2021]

A dietary supplement of fungal oil (containing arachidonic acid) and microalgal oil (containing docosahexaenoic acid) was found to be safe for healthy adults, with no significant adverse effects observed over a 14-day period.

The supplementation led to a significant increase in plasma levels of arachidonic acid (18%) and docosahexaenoic acid (50%) at a dose equivalent to what infants receive from human milk, indicating effective absorption and potential benefits for lipid profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plasma fatty acid responses, metabolic effects, and safety of microalgal and fungal oils rich in arachidonic and docosahexaenoic acids in healthy adults. Innis, SM., Hansen, JW.[2018]

In a 2-week study with 32 healthy participants, both algal-oil capsules and cooked salmon provided equivalent levels of docosahexaenoic acid (DHA) to plasma and red blood cells, indicating that algal oil is a viable alternative to fish sources.

Both DHA sources were well-tolerated, suggesting that algal-oil capsules are a safe and convenient option for obtaining DHA without consuming fish.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Algal-oil capsules and cooked salmon: nutritionally equivalent sources of docosahexaenoic acid. Arterburn, LM., Oken, HA., Bailey Hall, E., et al.[2010]

A study of 47 commercial fish, krill, and algal oil supplements revealed that over 70% did not contain the stated amounts of eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA), raising concerns about the quality and reliability of these products.

Only 21% of the supplements tested had at least 100% of the stated EPA content, and 25% had at least 100% of the stated DHA content, indicating a significant lack of regulatory oversight in the supplement industry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of actual versus stated label amounts of EPA and DHA in commercial omega-3 dietary supplements in the United States. Kleiner, AC., Cladis, DP., Santerre, CR.[2015]

The fortified powdered dairy drink significantly increased DHA intake among pregnant women, tripling their daily consumption from 48.8 mg to 147.8 mg, which is crucial for fetal development.

Women consuming the fortified drink showed improved DHA levels in their red blood cell membranes and a 50% increase in DHA concentration in their breast milk, indicating enhanced nutritional benefits for both mothers and newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Consumption of a DHA-enriched milk drink by pregnant and lactating women, on the fatty acid composition of red blood cells, breast milk, and in the newborn]. Atalah S, E., Araya B, M., Rosselot P, G., et al.[2016]

A 28-day study with 36 participants showed that two different algal DHA oil capsules (DHASCO-T and DHASCO-S) provided equivalent bioavailability of DHA, which is crucial for eye and brain health.

Both algal oil capsules and an algal-DHA-fortified food were found to be safe and well-tolerated, making them effective vegetarian sources of DHA with a linear dose-dependent response in plasma levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioequivalence of Docosahexaenoic acid from different algal oils in capsules and in a DHA-fortified food. Arterburn, LM., Oken, HA., Hoffman, JP., et al.[2018]

DHA-rich Algal Oil from Schizochytrium sp. was found to be safe in a 90-day study with Sprague-Dawley rats, showing no genotoxic effects and no adverse treatment-related effects on health indicators like body weight and behavior.

The study established a no observed adverse effect level (NOAEL) of 5 wt% in the diet, indicating that this level is safe for consumption without negative health impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of DHA-rich Algal Oil from Schizochytrium sp. Fedorova-Dahms, I., Marone, PA., Bauter, M., et al.[2011]

Nutrition bars fortified with nonemulsified, nonencapsulated fish oil can provide significant levels of omega-3 fatty acids (EPA and DHA), achieving up to 664.6 mg per serving without compromising consumer acceptability.

The fortified bars demonstrated good oxidative stability over a 10-week storage period, indicating that they can maintain quality and safety while delivering health benefits associated with omega-3 fatty acids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oxidative stability and consumer acceptance of fish oil fortified nutrition bars. Hughes, BH., Muzzy, HM., Laliberte, LC., et al.[2017]

A 90-day toxicity study in rats showed that DHASCO oil, an algal-derived source of DHA, is safe with no adverse effects observed at doses up to 1.25g/kg body weight/day.

The study confirmed that DHA from DHASCO oil is bioavailable, significantly increasing DHA levels in the liver, heart, and brain, making it a suitable option for infant formula fortification and dietary supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A combined subchronic (90-day) toxicity and neurotoxicity study of a single-cell source of docosahexaenoic acid triglyceride (DHASCO oil). Arterburn, LM., Boswell, KD., Koskelo, E., et al.[2019]

Feeding hens algal oils significantly increased the concentration of DHA in eggs without negatively affecting egg production or eggshell quality, demonstrating a viable alternative to fish oil for omega-3 enrichment.

The study involved 400 hens over a 12-week trial, and results showed that both standardized and crude algal oils effectively enriched eggs with DHA, with concentrations reaching up to 297 mg/100g egg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Egg production, egg quality, and fatty acids profiles in eggs and tissues in Lohmann LSL lite hens fed algal oils rich in docosahexaenoic acid (DHA). Maina, AN., Lewis, E., Kiarie, EG.[2023]

Citations

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Algal-oil supplements are a viable alternative to fish-oil ... Algal-oil significantly improved DHA levels in vegetarians and vegans. •. DHA from algal oil was accumulated more than DHA from fish oil. Abstract.

2. jn.nutrition.org jn.nutrition.org/article/S0022-3166(22)02946-7/fulltext

A Meta-Analysis Shows That Docosahexaenoic Acid from ... DHA from algal oil may reduce serum triglycerides and increase both HDL-C and LDL-C in people without coronary heart disease.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9684969/

Changes in fatty acid levels after consumption of a novel ... Several studies in humans have reported a significant increase in serum DHA after intake of algal oil supplements. Early studies on algal DHA ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9265382/

Health Benefits, Food Applications, and Sustainability of ... Today's consumers are increasingly aware of the beneficial effects of n-3 PUFA in preventing, delaying, and intervening various diseases, such as coronary ...

5. nature.com nature.com/articles/s41598-025-03319-7

Harnessing algae oil as a sustainable DHA source for ... This study aimed to develop a novel NE utilizing algae oil as a sustainable source of DHA, along with soybean lecithin as an emulsifier.

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GRAS Notice 1128, Algal oil (≥35% ... is safe for use in food. 13. 3) Safety Data Summary. The available published scientific data on the safety of DHA from algae and other sources ( ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-1565/algal-oil

Algal Oil - Uses, Side Effects, and More Algal oil rich in eicosapentaenoic acid (EPA) is possibly safe. It's been used safely for up to 3 months. Most side effects are mild and might include fishy ...

9. ams.usda.gov ams.usda.gov/sites/default/files/media/DHA%20Algal%20Oil%20TR.pdf

Docosahexaenoic Acid (DHA) Algal Oil Material Safety Data Sheet, Docosahexaenoic acid. Retrieved on July 15, 2011 from: 1086 http://www.matreya.com/ProductInfo.aspx?productid ...

10. lgbotanicals.com lgbotanicals.com/assets/images/SDS-ALGAE%20OIL%20-%2040%20DHA.pdf?srsltid=AfmBOoq2gWfuD9NM1xtShXK_Aqz7okmwxEgdn3Nf3dLfNq9sN4D2-I0p

SDS-ALGAE OIL - 40% DHA SYMPTOMS OF EXPOSURE: No significant reaction of the human body to the product known. Page 5. ALGAE OIL – 40% DHA – SAFETY DATA SHEET. Page 5 of ...