Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction

Study Overview
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Brief Summary
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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.

Detailed Description
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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%.

Official Title
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Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults

Conditions
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Inflammation

Intervention / Treatment
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* Dietary Supplement: Maqui berry/omeg-3 fatty acids
* Dietary Supplement: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized, controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Maqui berry extract and omega-3 fatty acids<br>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 | Dietary Supplement: Maqui berry/omeg-3 fatty acids<br>* 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<br>|
| Placebo Comparator: Control<br>4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin | Dietary Supplement: Placebos<br>* 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arachidonic acid (AA) | Blood concentration of AA | change from baseline at day 56 | 
| Eicosapentaenoic acid (EPA) | Blood concentration of EPA | change from baseline at day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maqui berry extract, omega-3 fatty acids, cytokines, blood lipids