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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04914312
Enrollment
32
Registered
2021-06-04
Start date
2022-01-15
Completion date
2023-08-15
Last updated
2023-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation

Keywords

maqui berry extract, omega-3 fatty acids, cytokines, blood lipids

Brief summary

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.

Detailed description

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%.

Interventions

DIETARY_SUPPLEMENTMaqui berry/omeg-3 fatty acids

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

DIETARY_SUPPLEMENTPlacebos

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

Sponsors

Arizona State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Masking description

Experimental capsules matched to placebo capsules

Intervention model description

randomized, controlled trial

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Interleukin-6 (IL-6)change from baseline at day 56Blood concentrations of IL-6
Interleukin-1 beta (IL-1 beta)change from baseline at day 56Blood concentration of IL-1 beta
Tumor Necrosis Factor (TNF)change from baseline at day 56Blood concentration of TNF

Secondary

MeasureTime frameDescription
Eicosapentaenoic acid (EPA)change from baseline at day 56Blood concentration of EPA
Arachidonic acid (AA)change from baseline at day 56Blood concentration of AA

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026