Clinical Trials Directory

Trials / Completed

CompletedNCT04914312

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
Phase
N/A
Study type
Interventional
Enrollment
32 (actual)
Sponsor
Arizona State University · Academic / Other
Sex
All
Age
50 Years – 85 Years
Healthy volunteers
Accepted

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%.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTMaqui berry/omeg-3 fatty acids2 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_SUPPLEMENTPlacebos4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Timeline

Start date
2022-01-15
Primary completion
2023-07-30
Completion
2023-08-15
First posted
2021-06-04
Last updated
2023-10-17

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04914312. Inclusion in this directory is not an endorsement.