Maqui Berry Extract + Omega-3 for Inflammation

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a mix of maqui berry extract and omega-3 fatty acids can lower certain inflammation markers (cytokines) in the body. It compares this combination to a placebo (inactive substance) to determine any benefits. The trial seeks individuals aged 50-85 who are generally healthy but have a Body Mass Index (BMI) between 30 and 40, indicating obesity. Participants should not smoke, engage in vigorous exercise, or take certain medications or supplements. As an unphased trial, this study offers participants the chance to contribute to valuable research on natural supplements and their potential health benefits.

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

Research has shown that omega-3 fatty acids are generally safe. Some individuals might experience mild side effects like diarrhea or a change in taste, though some studies found no side effects. Regarding maqui berry extract, research indicates it offers antioxidant benefits without specific safety concerns. Overall, both ingredients appear well-tolerated based on available evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Maqui berry extract and omega-3 fatty acids because it targets inflammation through a novel approach. Unlike current anti-inflammatory treatments that often focus on blocking specific pathways, this combination aims to reduce cytokine levels, which are proteins that play a crucial role in inflammation. Maqui berry extract is rich in antioxidants, and when paired with omega-3 fatty acids, it offers a natural and potentially less invasive way to manage inflammation. This treatment provides a unique blend of plant-based and marine-derived compounds that could offer broader health benefits beyond just cytokine reduction.

What evidence suggests that maqui berry and omega-3 fatty acids might be effective for reducing inflammatory cytokine levels?

Research has shown that omega-3 fatty acids, such as EPA and DHA, can reduce inflammation, which is important for heart health. Maqui berry extract may improve the body's ability to manage harmful molecules called free radicals. In this trial, one group of participants will receive a combination of maqui berry extract and omega-3s. Early studies suggest this combination might lower inflammation in the body by reducing proteins called inflammatory cytokines, which are involved in inflammation. Another group will receive a placebo for comparison. ^{1 2 6 7 8}

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

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04914312

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

There is much empirical evidence demonstrating beneficial effects of EPA supplementation, linked mainly to reductions in inflammation.

2.

researchgate.net

researchgate.net/profile/Attilio-Cavezzi/publication/316266839_Maqui_and_Omega_3_effects_on_lipid_profile_oxidative_stress_levels_and_psycho-physical_items_in_human_subjects/links/5908d61faca272f658fa99e4/Maqui-and-Omega-3-effects-on-lipid-profile-oxidative-stress-levels-and-psycho-physical-items-in-human-subjects.pdf

.42 Maqui and Omega 3: effects on lipid profile, oxidative ...

The results of this preliminary study confirm the statistically significant improvement of the two main biomarkers of oxidative stress (total free radicals and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12291892/

Effect of Supplementation of Antioxidant Lipids Synthetized by ...

Both EPA and DHA are especially recognized for their beneficial effects in reducing the risk of cardiovascular diseases, mitigating inflammation ...

4.

withpower.com

withpower.com/trial/phase-inflammation-5-2021-d8d21

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

Research shows that omega-3 fatty acids, found in fish oils, have anti-inflammatory effects and may help with heart health and certain cancers.

5.

semanticscholar.org

semanticscholar.org/paper/MaquiBright%E2%84%A2-standardized-maqui-berry-extract-tear-Hitoe-Tanaka/22d112f2b05bf2f46632a7a918cda81864312877

MaquiBright™ standardized maqui berry extract ...

MaquiBright™ standardized maqui berry extract significantly increases tear fluid production and ameliorates dry eye-related symptoms in a clinical pilot trial.

6.

patents.google.com

patents.google.com/patent/US20180243253A1/en

Formulations containing omega-3 fatty acids or esters ...

Provided herein are methods, formulations, and compositions related to omega-3 fatty acids or esters thereof and maqui berry extract.

7.

anklam-extrakt.de

anklam-extrakt.de/site/assets/files/1337/article-maqui-berry-extract-and-omega-3-no_3-2018.pdf

Maqui berry extract and Omega-3

Due to its high content in antioxidant phytochemicals, MaquiBright® was shown to restore tear fluid generation by acting on stressed lacrimal ...

8.

researchgate.net

researchgate.net/publication/316266839_Maqui_and_Omega_3_effects_on_lipid_profile_oxidative_stress_levels_and_psycho-physical_items_in_human_subjects

Maqui and Omega 3: effects on lipid profile, oxidative ...

Conclusions: daily supplementation with Maqui 600 mg + Omega 3 fatty acids ... data do not report any speci c safety issue for the. two ...