Arizona State University
Phoenix, Arizona, 85004, United States
NCT Number: NCT04914312
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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Notify Me50 year–85 year
All sexes
Interventional
Not applicable
Phoenix, Arizona, 85004, United States
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%.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
Time frame: change from baseline at day 56
Blood concentrations of IL-6
Time frame: change from baseline at day 56
Blood concentration of IL-1 beta
Time frame: change from baseline at day 56
Blood concentration of TNF
Time frame: change from baseline at day 56
Blood concentration of AA
Time frame: change from baseline at day 56
Blood concentration of EPA
Arizona State University
Other
Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults
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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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