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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation
• Intervention / Treatment: Dietary supplement: Maqui berry/omeg-3 fatty acids; Dietary supplement: Placebos

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maqui berry extract and omega-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	Dietary supplement: 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
Placebo Comparator: Control; 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin	Dietary supplement: Placebos; 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: May 31, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: cytokines; omega-3 fatty acids; blood lipids; maqui berry extract
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: STUDY00014007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No