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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Algae Oil Capsule and related products in the clinical trial EPA/DHA Supplements for Healthy Eating?

Research shows that DHA from algal oils in capsules and fortified foods is bioequivalent, meaning they provide similar levels of DHA in the body, which is important for brain and heart health. Additionally, EPA-rich extracts from microalgae have been shown to improve cholesterol levels, suggesting potential cardiovascular benefits. ^{1 2 3 4 5}

Is DHA-rich algal oil safe for human consumption?

Research shows that DHA-rich algal oil, used in various forms like capsules and fortified foods, is generally safe for human consumption. Studies in both humans and animals have shown no significant adverse effects, indicating a good safety profile. ^{1 2 6 7 8}

How is the Algae Oil Capsule and Algae Oil Fortified Soymilk treatment different from other treatments?

This treatment is unique because it uses algae-derived oils to provide omega-3 fatty acids like DHA and EPA, offering a vegetarian alternative to fish oil supplements. It is bioequivalent to fish oil in delivering DHA to the body, making it a safe and convenient option for those who prefer non-fish sources. ^{1 9 10 11 12}

Research Team

Yael Vodovotz, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

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

I have anemia or a condition that affects safe blood donation.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bioequivalence of Docosahexaenoic acid from different algal oils in capsules and in a DHA-fortified food. [2018]

2. England 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. [2014]

3. Switzerland 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. [2021]

4. United States 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. [2018]

5. England 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). [2023]

6. England 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). [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety evaluation of DHA-rich Algal Oil from Schizochytrium sp. [2011]

8. England pubmed.ncbi.nlm.nih.gov

Toxicologic evaluation of DHA-rich algal oil: Genotoxicity, acute and subchronic toxicity in rats. [2012]

9. Venezuela 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]. [2016]

10. England 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. [2015]

11. United States pubmed.ncbi.nlm.nih.gov

Algal-oil capsules and cooked salmon: nutritionally equivalent sources of docosahexaenoic acid. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

Oxidative stability and consumer acceptance of fish oil fortified nutrition bars. [2017]