Inflammation
Conditions
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
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
Sponsors
Study design
Masking description
Experimental capsules matched to placebo capsules
Intervention model description
randomized, controlled trial
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Interleukin-6 (IL-6) | change from baseline at day 56 | Blood concentrations of IL-6 |
| Interleukin-1 beta (IL-1 beta) | change from baseline at day 56 | Blood concentration of IL-1 beta |
| Tumor Necrosis Factor (TNF) | change from baseline at day 56 | Blood concentration of TNF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eicosapentaenoic acid (EPA) | change from baseline at day 56 | Blood concentration of EPA |
| Arachidonic acid (AA) | change from baseline at day 56 | Blood concentration of AA |
Countries
United States