The Açaí trial will be testing if the açaí berry extract, a safe natural product withanti-inflammatory properties, can be used as a treatment option in adult patients withCOVID-19 in the community.
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.
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.
Other: Placebo
Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.
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.
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
Heart Health Institute Research Inc
Toronto, Ontario, Canada