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

Not Applicable

Completed

• Conditions: Inflammation
• Interventions: Dietary Supplement: Maqui berry/omeg-3 fatty acids; Dietary Supplement: Placebos

• Registration Number: NCT04914312
• Lead Sponsor: Arizona State University

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%.

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-04
• Study Start: 2022-01-15
• Primary Completion: 2023-07-30
• Study Completion: 2023-08-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maqui berry extract and omega-3 fatty acids	Maqui berry/omeg-3 fatty acids	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	Placebos	4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Arachidonic acid (AA)	change from baseline at day 56	Blood concentration of AA
Eicosapentaenoic acid (EPA)	change from baseline at day 56	Blood concentration of EPA

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States