32 Participants Needed

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

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Overseen ByCarol S Johnston, PhD

Trial Summary

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.

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.12345

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-3.36789

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.1381011

Eligibility Criteria

Inclusion Criteria

Males and females 50-85 years old
Generally healthy, non-smoker
Able to provide informed consent
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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.
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Timeline

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

Treatment Details

Interventions

  • Maqui berry/omega-3 fatty acids
  • Placebos
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Maqui berry extract and omega-3 fatty acidsExperimental Treatment1 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: ControlPlacebo Group1 Intervention
4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Find a Clinic Near You

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials
311
Recruited
109,000+

Findings from Research

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.
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.
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]

References

Role of omega-3 fatty acid supplementation in inflammation and malignancy. [2013]
Is antioxidant and n-3 supplementation able to improve functional status in poststroke patients? Results from the Nutristroke Trial. [2022]
Safety of Supplementation of Omega-3 Polyunsaturated Fatty Acids: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2023]
The effect of omega-3 FAs on tumour angiogenesis and their therapeutic potential. [2013]
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]
From Inuit to implementation: omega-3 fatty acids come of age. [2022]
Efficacy and safety of prescription omega-3 fatty acids for the prevention of recurrent symptomatic atrial fibrillation: a randomized controlled trial. [2016]
Supplementation with alpha-linolenic acid and inflammation: a feasibility trial. [2021]
Jumping on the omega-3 bandwagon: distinguishing the role of long-chain and short-chain omega-3 fatty acids. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Bioequivalence Demonstration for Ω-3 Acid Ethyl Ester Formulations: Rationale for Modification of Current Guidance. [2019]
Omega-3 fatty acids supplementation and oxidative stress parameters: A systematic review and meta-analysis of clinical trials. [2020]