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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.
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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maqui berry extract and omega-3 fatty acids | Experimental | 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 |
|
| Control | Placebo Comparator | 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maqui berry/omeg-3 fatty acids | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Interleukin-6 (IL-6) | Blood concentrations of IL-6 | change from baseline at day 56 |
| Interleukin-1 beta (IL-1 beta) | Blood concentration of IL-1 beta | change from baseline at day 56 |
| Tumor Necrosis Factor (TNF) | Blood concentration of TNF | change from baseline at day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Arachidonic acid (AA) | Blood concentration of AA | change from baseline at day 56 |
| Eicosapentaenoic acid (EPA) | Blood concentration of EPA |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85004 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized, controlled trial
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Experimental capsules matched to placebo capsules
| Placebos | Dietary Supplement | 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin |
|
| change from baseline at day 56 |