200 Participants NeededMy employer runs this trial

Fish Oil for Omega-3 Enhancement

JL
MJ
Overseen ByMarcelo J Amar, M.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare how a new type of fish oil, rich in very-long-chain omega-3 fatty acids (VLCPUFAs), affects omega-3 levels in the blood compared to standard fish oil. Researchers seek to determine if this new fish oil can better boost omega-3 levels and improve health markers. Healthy adults with a BMI between 18 and 30 who do not currently use omega-3 supplements may be eligible. Participants will take two different types of fish oil capsules in separate phases and undergo blood tests to measure changes. As an unphased trial, this study allows participants to contribute to important research on dietary supplements and their potential health benefits.

Do I need to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications, especially if they include omega-3 supplements, anticoagulants, or medications affecting lipid metabolism. It's best to discuss your current medications with the study team to see if they are allowed.

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

Past studies have generally found fish oil high in DHA (a type of omega-3 fatty acid) easy for people to handle. Some individuals might experience mild side effects like low blood pressure, acid reflux, or headaches if they take too much, but these are uncommon.

Research has also shown that fish oil with very-long-chain omega-3 fatty acids is safe to use. However, some studies found that omega-3 supplements can sometimes cause diarrhea. Despite this, omega-3 fatty acids are widely regarded as safe and beneficial for health.

Researchers are studying both types of fish oil to see how they affect omega-3 levels in the blood. For those considering joining a trial, it's important to know these oils have been used in many studies without major safety concerns.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these fish oil treatments because they offer a unique approach to enhancing omega-3 levels in the body, which is linked to numerous health benefits. Unlike standard omega-3 supplements, these treatments focus on different types of omega-3 fatty acids: one is rich in DHA (docosahexaenoic acid) and the other in VLCPUFAs (very long-chain polyunsaturated fatty acids). This targeted composition could potentially offer more tailored and effective health benefits compared to generic fish oil supplements. The crossover design of the study allows researchers to compare the effects of each type of fish oil directly, providing valuable insights into which formulation might be more beneficial for specific health outcomes.

What evidence suggests that this trial's treatments could be effective for enhancing omega-3 levels?

This trial will evaluate two types of fish oil: DHA-rich fish oil and VLCPUFA-rich fish oil. Studies have shown that fish oil high in DHA (a type of omega-3 fatty acid) can slow memory problems and improve mental health. Additionally, DHA-rich fish oil may lower blood pressure and reduce triglycerides, fats in the blood. Research has indicated that certain omega-3 fatty acids in fish oil can reduce the risk of heart issues, such as irregular heartbeats, and improve eyesight. These findings suggest that fish oils, whether high in DHA or other omega-3s, positively impact overall health, particularly for the heart and brain. Participants in this trial will receive both types of fish oil in a crossover design to assess their effects.678910

Who Is on the Research Team?

MJ

Marcelo J Amar, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 to 60 with a BMI between 18 and 30. Participants should not have major health problems and must be able to attend several clinic visits over about seven months.

Inclusion Criteria

Screening labs within normal levels with minor deviations allowed per PI discretion
Ability to take oral medication
Participant demonstrates willingness to sign the informed consent form and comply with all study procedures
See 3 more

Exclusion Criteria

I have a history of conditions that affect how my body absorbs fat from food.
I am currently taking blood thinners or antiplatelet medication.
Pregnancy (or planned pregnancy) or lactation
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

First Treatment Period

Participants take 2 fish oil capsules daily for 8 weeks, either VLCPUFA-rich or DHA-rich fish oil

8 weeks
2 visits (in-person)

Washout Period

Participants stop taking study capsules for about 12 weeks

12 weeks
No visits

Second Treatment Period

Participants take 2 fish oil capsules daily for 8 weeks, switching to the other type of fish oil

8 weeks
2 visits (in-person)

Follow-up

Participants receive a follow-up phone call about one week after taking their last dose of study supplement

1 week
1 call (phone)

What Are the Treatments Tested in This Trial?

Interventions

  • DHA-rich fish oil
  • VLCPUFA-rich fish oil

Trial Overview

The study compares two types of fish oil capsules: one rich in very-long-chain omega-3s (VLCPUFAs) and the other with standard omega-3s. Each participant takes both types at different times, separated by a break, to see how each affects blood omega-3 levels.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: VLCPUFA-rich Fish Oil DHA-rich Fish OilExperimental Treatment2 Interventions
Group II: DHA-rich Fish Oil VLCPUFA-rich Fish OilExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Heart, Lung, and Blood Institute (NHLBI)

Lead Sponsor

Trials
3,987
Recruited
47,860,000+

Citations

New Breakthroughs in Omega-3 Research

After one year, only 10.5% of the subjects in the fish oil group progressed to failure of the drug therapy, while 32.1% of those in the control group progressed ...

EPA & DHA Science Research Review

EPA and DHA are long-chain omega-3 fatty acids that are considered conditionally essential for health. Good sources of EPA and DHA in the diet include oily fish ...

Choosing an Omega-3 Supplement

The good news is that hundreds of scientific studies provide evidence-based support for omega-3 supplementation in a variety of health conditions.

Fish oils and omega-3 oils: Benefits, foods, and risks

The review suggests that fish oil supplements may help reduce inflammation and the relapsing rate and improve quality of life in people with MS.

Effects of a Fish Oil Rich in Docosahexaenoic Acid on ...

Supplementation with the fish oil containing 80% DHA decreased plasma fat, plasma total cholesterol and muscle fat compared to the coconut oil ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25044306/

A comparison of actual versus stated label amounts of EPA ...

For algal oil supplements, EPA ranged from 7.7 to 151.1 mg g(-1) oil and DHA ranged from 237.8 to 423.5 mg g(-1) oil. The percentage of the stated label amount ...

9 Little-Known Side Effects of Too Much Fish Oil

Consuming too much fish oil may result in low blood pressure, acid reflux, diarrhea, headaches, a fishy smell, and, in some individuals, an ...

Omega-3 Supplements National Study | DSID | USDA and NIH ...

Results high variability among product lots, or questionable data from batches where QC results showed a bias Statistical Analysis. DHA -1.7%*

When it comes to omega-3s, EPA and DHA

Aim for at least 500mg EPA+DHA per day. heart, brain and eye health. There was also a 10 percent reduced risk for low birth weight (babies born ...

Omega-3 Fatty Acids White Paper

fish oil containing 1,680 mg EPA and 1,120 mg DHA led to a stabilization of feelings of anger and confusion after being exposed to a psychological stressor.*26