Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction
Primary Purpose
Inflammation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maqui berry/omeg-3 fatty acids
Placebos
Sponsored by

About this trial
This is an interventional other trial for Inflammation focused on measuring maqui berry extract, omega-3 fatty acids, cytokines, blood lipids
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.
Sites / Locations
- Arizona State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Maqui berry extract and omega-3 fatty acids
Control
Arm Description
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
4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
Outcomes
Primary Outcome Measures
Interleukin-6 (IL-6)
Blood concentrations of IL-6
Interleukin-1 beta (IL-1 beta)
Blood concentration of IL-1 beta
Tumor Necrosis Factor (TNF)
Blood concentration of TNF
Secondary Outcome Measures
Arachidonic acid (AA)
Blood concentration of AA
Eicosapentaenoic acid (EPA)
Blood concentration of EPA
Full Information
NCT ID
NCT04914312
First Posted
May 31, 2021
Last Updated
October 13, 2023
Sponsor
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT04914312
Brief Title
Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction
Official Title
Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
maqui berry extract, omega-3 fatty acids, cytokines, blood lipids
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, controlled trial
Masking
ParticipantInvestigator
Masking Description
Experimental capsules matched to placebo capsules
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Maqui berry extract and omega-3 fatty acids
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Maqui berry/omeg-3 fatty acids
Intervention Description
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
Intervention Name(s)
Placebos
Intervention Description
4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
Primary Outcome Measure Information:
Title
Interleukin-6 (IL-6)
Description
Blood concentrations of IL-6
Time Frame
change from baseline at day 56
Title
Interleukin-1 beta (IL-1 beta)
Description
Blood concentration of IL-1 beta
Time Frame
change from baseline at day 56
Title
Tumor Necrosis Factor (TNF)
Description
Blood concentration of TNF
Time Frame
change from baseline at day 56
Secondary Outcome Measure Information:
Title
Arachidonic acid (AA)
Description
Blood concentration of AA
Time Frame
change from baseline at day 56
Title
Eicosapentaenoic acid (EPA)
Description
Blood concentration of EPA
Time Frame
change from baseline at day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction
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