Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction

Overseen By Carol S Johnston, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Blood thinners, Anti-inflammatories

Disqualifiers: Auto-immune conditions, Vigorous exercise, others

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a mix of maqui berry extract and omega-3 fatty acids can lower inflammation in older, obese adults. Maqui berries have special plant pigments that reduce inflammation, and omega-3s are known for their anti-inflammatory effects. Maqui berries (Aristotelia chilensis) are known for their antioxidant, anticancer, and anti-inflammatory properties.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications, such as blood thinners, anti-inflammatory drugs, cardiovascular medications, lipid-altering drugs, and hormone replacement therapy, to participate in this trial.

Is the treatment with omega-3 fatty acids safe for humans?

Omega-3 fatty acids are generally considered safe for humans, but they may cause side effects like diarrhea and taste changes. A study found no side effects in a small group taking alpha-linolenic acid, a type of omega-3. ^{1 2 3 4 5}

How does the Maqui berry/omega-3 fatty acids treatment differ from other treatments?

This treatment is unique because it combines Maqui berry, known for its antioxidant properties, with omega-3 fatty acids, which have anti-inflammatory effects. This combination may offer a novel approach to reducing inflammation and oxidative stress, which are not typically addressed together in standard treatments. ^{1 4 6 7 8}

What data supports the effectiveness of the treatment Maqui berry/omega-3 fatty acids?

Research shows that omega-3 fatty acids, found in fish oils, have anti-inflammatory effects and may help with heart health and certain cancers. They have been studied for their potential benefits in reducing inflammation and supporting cardiovascular health. ^{1 8 9 10 11}

Are You a Good Fit for This Trial?

Inclusion Criteria

Males and females 50-85 years old

Generally healthy, non-smoker

Able to provide informed consent

Exclusion Criteria

Use of warfarin or other blood thinners

Use of anti-inflammatory drugs, cardiovascular medications, lipid-altering drugs, and hormone replacement therapy

Individuals engaged in vigorous exercise (>2 x 30 min/week), vegetarians, and people who routinely take multivitamins or herbal supplements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive maqui berry extract and omega-3 fatty acids or placebo for cytokine reduction

8 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

• Maqui berry/omega-3 fatty acids
• Placebos

How Is the Trial Designed?

Group I: Maqui berry extract and omega-3 fatty acids Experimental Treatment 1 Intervention

2 capsules BID per day containing a total of 600 mg of Maqui extract; 4 capsules per day supplying a total of 2000 mg EPA and 1000 mg DHA

Group II: Control Placebo Group 1 Intervention

4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Published Research Related to This Trial

In a study of 72 stroke patients over 12 months, supplementation with n-3 fatty acids showed a trend towards lower mortality rates, suggesting potential benefits for stroke survivors' long-term health.

Despite the lack of significant differences in rehabilitation outcomes among the treatment groups, the study highlighted the prevalence of malnutrition in stroke patients, indicating that dietary supplementation may be important for improving overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is antioxidant and n-3 supplementation able to improve functional status in poststroke patients? Results from the Nutristroke Trial. Garbagnati, F., Cairella, G., De Martino, A., et al.[2022]

A comprehensive review of 90 randomized controlled trials found that omega-3 polyunsaturated fatty acids (PUFAs) are associated with a higher likelihood of certain adverse effects, including diarrhea, dysgeusia (altered taste), and bleeding tendency, compared to placebo.

Despite these adverse effects, there were no serious adverse events reported related to omega-3 PUFA supplementation, suggesting that while they may cause some minor issues, they are generally safe and tolerable for most individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Chang, JP., Tseng, PT., Zeng, BS., et al.[2023]

Citations

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

Role of omega-3 fatty acid supplementation in inflammation and malignancy. [2013]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Is antioxidant and n-3 supplementation able to improve functional status in poststroke patients? Results from the Nutristroke Trial. [2022]

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

Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The effect of omega-3 FAs on tumour angiogenesis and their therapeutic potential. [2013]

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

OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction. [2022]

6. England pubmed.ncbi.nlm.nih.gov

From Inuit to implementation: omega-3 fatty acids come of age. [2022]

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

Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. [2016]

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

Supplementation with alpha-linolenic acid and inflammation: a feasibility trial. [2021]

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

Jumping on the omega-3 bandwagon: distinguishing the role of long-chain and short-chain omega-3 fatty acids. [2019]

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

Bioequivalence Demonstration for Ω-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Omega-3 fatty acids supplementation and oxidative stress parameters: A systematic review and meta-analysis of clinical trials. [2020]