Clinical trial NCT04914312: Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction
Official title: Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Keywords: maqui berry extract
omega-3 fatty acids
cytokines
blood lipids
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled trial
Primary purpose: OTHER

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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Interleukin-6 (IL-6)
timeFrame: change from baseline at day 56
measure: Interleukin-1 beta (IL-1 beta)
timeFrame: change from baseline at day 56
measure: Tumor Necrosis Factor (TNF)
timeFrame: change from baseline at day 56
Secondary outcomes:
measure: Arachidonic acid (AA)
timeFrame: change from baseline at day 56
measure: Eicosapentaenoic acid (EPA)
timeFrame: change from baseline at day 56
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References: