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Completed

NCT Number: NCT04914312

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

The purpose of this trial is to determine the effect of maqui extract plus omega-3 fatty acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

Anthocyanins, a subclass of flavonoids, are plant pigments that provide the rich color of many plants, fruits, and flowers. Health benefits of anthocyanins have been widely reported in the research literature, particularly for disease conditions associated with oxidative stress, such as cardiovascular and neurodegenerative diseases. Emerging evidence suggests that anthocyanins may also modulate gut microbiota, which can impact a wide variety of health conditions. Maqui berries (Aristotelia chilensis), indigenous to Chile, have one of the highest concentrations of anthocyanins in the plant world; moreover, the dominant anthocyanin in maqui berries is delphinidin. Delphinidin is more bioavailable than most flavonoids, with intact molecules absorbed in appreciable amounts in less than an hour after consumption. Systemic effects of delphinidin include reduced inflammation due to downregulation of NF-kB, the transcription factor that initiates the generation of pro-inflammatory cytokines. The omega-3 fatty acid eicosapentaenoic acid [EPA], a component of omega-3 fatty acid concentrates, also has anti-inflammatory properties. There is much empirical evidence demonstrating beneficial effects of EPA supplementation, linked mainly to reductions in inflammation. It has been demonstrated the dietary supplementation with EPA-rich marine oil concentrations reduces cytokine levels up to 15%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 50-85 years old
  • Generally healthy, non-smoker
  • Able to provide informed consent
  • BMI: 30-40 kg/m2

Exclusion criteria

  • Existing auto-immune conditions
  • 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.

Treatment and study plan

Maqui berry/omeg-3 fatty acids

Dietary Supplement

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

Placebos

Dietary Supplement

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

Primary outcomes

  1. Interleukin-6 (IL-6)

    Time frame: change from baseline at day 56

    Blood concentrations of IL-6

  2. Interleukin-1 beta (IL-1 beta)

    Time frame: change from baseline at day 56

    Blood concentration of IL-1 beta

  3. Tumor Necrosis Factor (TNF)

    Time frame: change from baseline at day 56

    Blood concentration of TNF

Secondary outcomes

  1. Arachidonic acid (AA)

    Time frame: change from baseline at day 56

    Blood concentration of AA

  2. Eicosapentaenoic acid (EPA)

    Time frame: change from baseline at day 56

    Blood concentration of EPA

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study title

Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 4, 2021
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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