InflammationNCT04914312
Maqui Berry Extract and Omega-3 Fatty Acids for Cytokine Reduction
A study testing Maqui berry/omeg-3 fatty acids in people with Inflammation, run by Arizona State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Maqui berry/omeg-3 fatty acids
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 50-85 years old
- Generally healthy, non-smoker
- Able to provide informed consent
- BMI: 30-40 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Maqui berry/omeg-3 fatty acids, Placebos
- Keywords
- maqui berry extract, omega-3 fatty acids, cytokines, blood lipids
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maqui berry/omeg-3 fatty acidsDietary 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
PlacebosDietary supplement
4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Maqui berry/omeg-3 fatty acids |
| Control | Placebo comparator | 4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin Receives: Dietary Supplement: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 (IL-6)
Blood concentrations of IL-6
Measured: change from baseline at day 56
Interleukin-1 beta (IL-1 beta)
Blood concentration of IL-1 beta
Measured: change from baseline at day 56
Tumor Necrosis Factor (TNF)
Blood concentration of TNF
Measured: change from baseline at day 56
Secondary outcomes (2)
Arachidonic acid (AA)
Blood concentration of AA
Measured: change from baseline at day 56
Eicosapentaenoic acid (EPA)
Blood concentration of EPA
Measured: change from baseline at day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start15 Jan 2022
- Primary completion30 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Johnston, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914312
- Sponsor's protocol ID
- STUDY00014007
- Status last verified
- Oct 2023
- First submitted
- 31 May 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Maqui Berry Extract Combination With Omega-3 Fatty Acids on Cytokine Reduction in Elderly Obese Adults
- ClinicalTrials.gov ID
- NCT04914312
- Acronym / sponsor ID
- STUDY00014007
- Conditions
- Inflammation
- Keywords
- maqui berry extract, omega-3 fatty acids, cytokines, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Maqui berry extract and omega-3 fatty acids | Experimental | Dietary Supplement: Maqui berry/omeg-3 fatty acids2 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 | Placebo comparator | Dietary Supplement: Placebos4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females 50-85 years old
- Generally healthy, non-smoker
- Able to provide informed consent
- BMI: 30-40 kg/m2
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maqui berry/omeg-3 fatty acids2 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 extract and omega-3 fatty acids |
| Placebos4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin | Dietary supplement | Control |
Primary outcome
Interleukin-6 (IL-6)
Time frame: change from baseline at day 56
Blood concentrations of IL-6
Interleukin-1 beta (IL-1 beta)
Time frame: change from baseline at day 56
Blood concentration of IL-1 beta
Tumor Necrosis Factor (TNF)
Time frame: change from baseline at day 56
Blood concentration of TNF
2 secondary outcomes
Arachidonic acid (AA)
Time frame: change from baseline at day 56
Eicosapentaenoic acid (EPA)
Time frame: change from baseline at day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maqui berry/omeg-3 fatty acids in people with Inflammation, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 (IL-6) (time frame: change from baseline at day 56). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023.