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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914312
• Other study ID #: STUDY00014007
• Status: Completed
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: August 15, 2023

Study information

• Verified date: October 2023
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation

Intervention

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

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interleukin-6 (IL-6)	Blood concentrations of IL-6	change from baseline at day 56
Primary	Interleukin-1 beta (IL-1 beta)	Blood concentration of IL-1 beta	change from baseline at day 56
Primary	Tumor Necrosis Factor (TNF)	Blood concentration of TNF	change from baseline at day 56
Secondary	Arachidonic acid (AA)	Blood concentration of AA	change from baseline at day 56
Secondary	Eicosapentaenoic acid (EPA)	Blood concentration of EPA	change from baseline at day 56