The Açaí Berry COVID-19 Anti-Inflammation Trial (ACAI)
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| ClinicalTrials.gov Identifier: NCT04404218 |
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Recruitment Status :
Active, not recruiting
First Posted : May 27, 2020
Last Update Posted : May 31, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID | Dietary Supplement: Açaí palm berry extract - natural product Other: Placebo | Phase 2 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 480 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Prospective, double-blinded, placebo-controlled, randomized, multicentre clinical trial |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Double blinding, using placebo pills. |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Clinical Trial of Açaí Palm Berry Extract as an Intervention in Patients Diagnosed With COVID-19 |
| Actual Study Start Date : | August 4, 2020 |
| Estimated Primary Completion Date : | June 15, 2022 |
| Estimated Study Completion Date : | December 2022 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Dietary Supplement: Açaí palm berry extract - natural product
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. |
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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.
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Other: Placebo
Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days. |
- 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.
- 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
- The composite of all-cause mortality and hospitalization [ Time Frame: 30 days ]First occurrence of all-cause mortality or hospitalization
- All-cause mortality [ Time Frame: 30 days ]All-cause mortality
- Need for mechanical ventilation [ Time Frame: 30 days ]Need for mechanical ventilation
- Need for hospitalization [ Time Frame: 30 days ]Need for hospitalization
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04404218
| Brazil | |
| Instituto de Pesquisas em Saude (IPS)/ Universidade de Caxias do Sul (UCS) | |
| Caxias Do Sul, RS, Brazil | |
| Instituto Prevent Senior (IPS) - Hospital Sancta Maggiore | |
| Sao Paulo, SP, Brazil | |
| Canada, Ontario | |
| Heart Health Institute Research Inc | |
| Toronto, Ontario, Canada, M1B 4Z8 | |
| 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 |
| Responsible Party: | Michael Farkouh, Chair & Director, Peter Munk Centre of Excellence in Multinational Clinical Trials, University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT04404218 |
| Other Study ID Numbers: |
CTO3176 |
| First Posted: | May 27, 2020 Key Record Dates |
| Last Update Posted: | May 31, 2022 |
| Last Verified: | May 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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açaí berry COVID community care patients |