- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04404218
The Açaí Berry COVID-19 Anti-Inflammation Trial (ACAI)
Randomized Clinical Trial of Açaí Palm Berry Extract as an Intervention in Patients Diagnosed With COVID-19
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current COVID-19 pandemic is caused by the novel coronavirus (SARS-Cov-2). The virus origins have been studied and evidence so far suggests it originates in bats, with spread to humans likely mediated by an intermediate mammalian. Bats have a dampened Nod-like receptor family, pyrin-containing 3 (NLRP3)-mediated inflammation. Dampening NLRP3-mediated inflammation has been associated with the asymptotic viral status, therefore it is plausible that the pathogenic inflammatory response of SARS-CoV-2 might be associated with activation of NLRP3 inflammasome. Data show that the natural extract of Açaí Palm Berry (Euterpe oleracea Mart.) is a potent inhibitor of NLRP3. This is a safe, inexpensive, and readily available natural health supplement which could be a rapid response treatment intervention for patients with COVID-19.
Our primary objective is to establish whether açai palm berry extract (Euterpe oleracea), given to community-dwelling adult patients diagnosed with COVID-19, compared to placebo, improves outcomes over 30 days on the 7-point ordinal scale described by Cao et al, and which is being used widely in COVID-19 trials with the aim of harmonizing endpoints. This study will be a prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial of Açaí Palm Berry extract in adult patients tested positive for SARS-Cov-2 in the last 7 days and that are currently being treated in the outpatient setting. The intervention group will receive 3 capsules of 520mg (one capsule every eight hours) of Acai Palm Berry extract (Nature's Way, NPN80038874) for 30 days. The non-intervention group will receive placebo pills, on top of standard clinical care. Our main endpoint will be the 7-point ordinal scale.
This project has the benefit of offering a safe and widely used natural extract as a potential treatment strategy to decrease inflammation and improve disease outcomes in patients with COVID-19. With no vaccine currently available, the search for effective treatments is a timely approach. The potential impact of such a therapeutic agent, if effective, can be quite vast given that it can be readily used by anyone and, most importantly, is affordable in many countries.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adults over 40 years of age; and
- Mild to moderate symptoms including fever, dry cough, and tiredness; and
- Tested positive for SARS-Cov-2, via virological diagnosis (PCR), in the last 7 days; and
- Not hospitalized at the time of randomization, with no limitations on activities; and
- Willingness to complete questionnaires and records associated with the study.
Exclusion Criteria:
- Hospitalized patients at the time of enrollment; or
- Known allergy to study medication or its non-medicinal ingredients; or
- Currently taking açai extract or juice; or
- Chronic severe renal impairment (creatinine clearance <30 mL/min or on renal replacement therapy); or
- Pregnant or breastfeeding patients; or
- Women who are planning to become pregnant during the study; or
- End-stage cancer or patients in whom imminent demise is anticipated and there is no commitment to active ongoing intervention; or
- Unable to provide informed consent; or
- Patients taking antiplatelet/blood-thinning medication; or
- Patients with unstable metabolic disease/chronic diseases/ diseases with any comorbidities and/or any serious medical condition or abnormality of clinical laboratory tests that precludes the patient's safe participation in and completion of the study or puts them in a greater risk of developing severe symptoms (e.g. Individuals with an acute infectious disease, immune-compromised, self-reported confirmation of HIV, other lung diseases such as asthma, emphysema, neurological conditions); or
- Patients who participated in other clinical research studies 30 days prior to screening; or
- Patients who are participating in another clinical trial at the same time.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Açaí palm berry extract
Açaí palm berry extract is a powerful antioxidant with no known side-effects and is widely consumed in Brazil.
Açaí palm berry chemical composition has been established and includes several antioxidants - gallic acid, catechin, chlorogenic acid, caffeic acid, p-coumaric acid, epicatechin, orientin, cyanidin-3-0-glucoside, luteolin and apigenin.
Orientin is the most concentrated compound (7,96mg/g) and this compound is able to modulate the NLRP3 inflammasome.
|
Patients will be prescribed to take 1 capsule (520mg) of Açaí Palm Berry every 8 hours for a total of 3 capsules a day, during 30 days.
Total dose: 1,560mg/day of Açaí Berry extract.
|
Placebo Comparator: Placebo arm
This study will be double-blinded and placebo-controlled.
To ensure double-blinding, placebo and active compound capsules will be over-encapsulated with DBCAPS® capsules, which were developed with a tamper-evident design to address the clinical trial challenges of testing without bias.
These capsules are made of gelatin and have no interaction with bioavailability.
|
Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-point ordinal symptom scale
Time Frame: 30 days
|
Symptom comparison between patients from the treatment vs control group, using an ordinal symptom scale based on the WHO scale.
Patients who were hospitalized will be classified according to their worst score over 30 days and non-hospitalized patients according to their score at 30 days.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The composite of all-cause mortality and need for mechanical ventilation
Time Frame: 30 days
|
First occurrence of all-cause mortality or need for mechanical ventilation
|
30 days
|
The composite of all-cause mortality and hospitalization
Time Frame: 30 days
|
First occurrence of all-cause mortality or hospitalization
|
30 days
|
All-cause mortality
Time Frame: 30 days
|
All-cause mortality
|
30 days
|
Need for mechanical ventilation
Time Frame: 30 days
|
Need for mechanical ventilation
|
30 days
|
Need for hospitalization
Time Frame: 30 days
|
Need for hospitalization
|
30 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michael Farkouh, MD, MSc, Peter Munk Cardiac Centre; University Health Network; University of Toronto
- Principal Investigator: Ana Andreazza, PhD, Department of Pharmacology & Toxicology; University of Toronto
Publications and helpful links
General Publications
- Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.
- Machado AK, Andreazza AC, da Silva TM, Boligon AA, do Nascimento V, Scola G, Duong A, Cadona FC, Ribeiro EE, da Cruz IB. Neuroprotective Effects of Acai (Euterpe oleracea Mart.) against Rotenone In Vitro Exposure. Oxid Med Cell Longev. 2016;2016:8940850. doi: 10.1155/2016/8940850. Epub 2016 Oct 3.
- Machado AK, Cadoná FC, Assmann CE, Andreazza AC, Duarte MMMF, Branco CS, Zhou X, Souza DV, Ribeiro EE, Cruz IBM. Açaí (Euterpe oleracea Mart.) has anti-inflammatory potential through NLRP3-inflammasome modulation. Journal of Functional Foods. Volume 56, 2019, Pages 364-371, https://doi.org/10.1016/j.jff.2019.03.034.
- Kim HK, Chen W, Andreazza AC. The Potential Role of the NLRP3 Inflammasome as a Link between Mitochondrial Complex I Dysfunction and Inflammation in Bipolar Disorder. Neural Plast. 2015;2015:408136. doi: 10.1155/2015/408136. Epub 2015 May 13.
- Kim HK, Andreazza AC, Elmi N, Chen W, Young LT. Nod-like receptor pyrin containing 3 (NLRP3) in the post-mortem frontal cortex from patients with bipolar disorder: A potential mediator between mitochondria and immune-activation. J Psychiatr Res. 2016 Jan;72:43-50. doi: 10.1016/j.jpsychires.2015.10.015. Epub 2015 Oct 26.
- Ulbricht C, Brigham A, Burke D, Costa D, Giese N, Iovin R, Grimes Serrano JM, Tanguay-Colucci S, Weissner W, Windsor R. An evidence-based systematic review of acai (Euterpe oleracea) by the Natural Standard Research Collaboration. J Diet Suppl. 2012 Jun;9(2):128-47. doi: 10.3109/19390211.2012.686347.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CTO3176
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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