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

NCT04914312 | Completed

• 1 other identifier: STUDY00014007
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation

Keywords

maqui berry extract; omega-3 fatty acids; cytokines; blood lipids

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Arachidonic acid (AA)

  change from baseline at day 56

• Eicosapentaenoic acid (EPA)

  change from baseline at day 56

Study Arms (2)

Maqui berry extract and omega-3 fatty acids

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Placebos

Interventions

Maqui berry/omeg-3 fatty acids 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

Maqui berry extract and omega-3 fatty acids

Placebos DIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 50-85 years old
• Generally healthy, non-smoker
• Able to provide informed consent
• BMI: 30-40 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Experimental capsules matched to placebo capsules
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Dean

Model Details: randomized, controlled trial

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 4, 2021
• Study Start: January 15, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 15, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)