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

NCT ID: NCT04914312

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-15
• Study Completion Date: 2023-08-15

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%.

Conditions

Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Maqui berry/omeg-3 fatty acids

Intervention Type: 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

Control

4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DIETARY_SUPPLEMENT

4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebos

4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Carol Johnston

Professor and Associate Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

STUDY00014007

Identifier Type: -

Identifier Source: org_study_id