InflammationNCT04912921
Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19
A study testing palmitoylethanolamide and Curcumin in people with Inflammation and COVID19, run by Arizona State University at 1 site in United States.
Trial summary
Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, COVID19
- What is being tested?
- palmitoylethanolamide and Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 15 May 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and females 18-65 years old
- Generally healthy
- Able to provide informed consent
- Recent positive COVID-19 test (per RT-PCR Test)*
Who cannot join
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma)
- Serious mood disorders, neurological disorders such as MS, or cognitive damage
- Active smokers and/or nicotine or drug abuse
- Active, regular marijuana or other cannabinoid use, other street/recreational drug use
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- Allergic to any of the ingredients in active or placebo formula including peanuts, eggs or turmeric
Show all 10Show fewer
- Pregnant or lactating woman
- People medically prescribed to take drugs that would affect the immune and/or the inflammatory response
- People who have had treatment (last 5 years) for cancer, or chronic use of steroids
- BMI >40
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Biomedical Collaborative
Phoenix, Arizona, 85004
About this study
Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)
Read the detailed description
Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease and tissue pathology. This research offers a natural, dietary approach to managing inflammation by reducing the mediators of inflammation. The beneficial effects of palmitoylethanolamide (PEA) and for curcumin for reducing inflammation is documented in the research literature. The proposed research will expand this literature in a novel manner. The investigators propose to demonstrate the efficacy of these dietary supplements in individuals from a campus population with robust immune protection - those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic. Since a college population is under many stressors which raise inflammatory profiles during the academic year, and since a college population is exposed to infectious agents on campus, maintaining strong protective immune system following a COVID-19 infection is important.
- Conditions
- Inflammation, COVID19
- Being tested
- palmitoylethanolamide, Placebo, Curcumin, Control (microcrystalline cellulose)
- Keywords
- palmitoylethanolamide, curcumin
- Medical subject headings
- Inflammation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palmitoylethanolamideDietary supplement
Also called Levagen
4 tablets taken daily (2 in the am and 2 in the pm)
PlaceboDietary supplement
Also called microcrystalline cellulose
4 tablets taken daily (2 in am and 2 in pm)
CurcuminDietary supplement
Also called Hydrocurc
500 mg HydroCurc® twice a day
Control (microcrystalline cellulose)Dietary supplement
Also called microcrystalline cellulose
2 tablets taken daily
| Study group | Role | What they receive |
|---|---|---|
| palmitoylethanolamide | Experimental | Levagen Receives: Dietary Supplement: palmitoylethanolamide |
| Placebo | Placebo comparator | microcrystalline cellulose Receives: Dietary Supplement: Placebo |
| HydroCurc | Experimental | curcumin Receives: Dietary Supplement: Curcumin |
| Control | Placebo comparator | microcrystalline cellulose Receives: Dietary Supplement: Control (microcrystalline cellulose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL6 concentration
interleukin-6
Measured: change from baseline at day 28
Secondary outcomes (6)
serum CRP concentration
C-reactive protein (high sensitivity)
Measured: change from baseline at day 28
serum ferritin concentration
serum ferritin
Measured: change from baseline at day 28
serum ICAM concentration
Intercellular Adhesion Molecule 1
Measured: change from baseline at day 28
serum NFk-beta concentration
nuclear factor kappa-light-chain-enhancer of activated B cells
Measured: change from baseline at day 28
serum white blood cell differential
white blood cell differential
Measured: change from baseline at day 28
serum p-selectin concentration
cell adhesion molecule
Measured: change from baseline at day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start20 Oct 2020
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blind, randomized, controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912921
- Sponsor's protocol ID
- STUDY00012462
- Status last verified
- Mar 2023
- First submitted
- 15 Oct 2020
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fessler SN, Liu L, Chang Y, Yip T, Johnston CS. Palmitoylethanolamide Reduces Proinflammatory Markers in Unvaccinated Adults Recently Diagnosed with COVID-19: A Randomized Controlled Trial. J Nutr. 2022 Oct 6;152(10):2218-2226. doi: 10.1093/jn/nxac154.
PubMed 36084236
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Palmitoylethanolamide on Proinflammatory Markers in Adults Recently Diagnosed With COVID-19
- ClinicalTrials.gov ID
- NCT04912921
- Acronym / sponsor ID
- STUDY00012462
- Conditions
- Inflammation, COVID19
- Keywords
- palmitoylethanolamide, curcumin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 3 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.
Two randomized controlled trials will be conducted to examine the effect of a food supplement on proinflammatory cytokines and biomarkers in an adult population recently diagnosed with COVID-19 who are asymptomatic or experiencing only mild symptoms. The supplement, palmitoylethanolamide (PEA), is marketed under the trademarked product with increased bioavailability and format versatility: Levagen+™ (Gencor Pacific Limited, Irvine, CA). The supplement curcumin is marketed under the trademarked product with increased bioavailability: HydroCurc (Gencor Pacific Limited, Irvine, CA)
Detailed description
Inflammation is at the core of many chronic conditions and exacerbates infectious conditions, and inflammatory responses appear to be key determinants of the severity of COVID-19 infection. Hence, controlling inflammation is considered a key strategy for slowing the progression of disease and tissue pathology. This research offers a natural, dietary approach to managing inflammation by reducing the mediators of inflammation. The beneficial effects of palmitoylethanolamide (PEA) and for curcumin for reducing inflammation is documented in the research literature. The proposed research will expand this literature in a novel manner. The investigators propose to demonstrate the efficacy of these dietary supplements in individuals from a campus population with robust immune protection - those who recently tested positive for COVID-19 but were asymptomatic or mildly symptomatic. Since a college population is under many stressors which raise inflammatory profiles during the academic year, and since a college population is exposed to infectious agents on campus, maintaining strong protective immune system following a COVID-19 infection is important.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- double-blind, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| palmitoylethanolamide | Experimental | Dietary Supplement: palmitoylethanolamideLevagen |
| Placebo | Placebo comparator | Dietary Supplement: Placebomicrocrystalline cellulose |
| HydroCurc | Experimental | Dietary Supplement: Curcumincurcumin |
| Control | Placebo comparator | Dietary Supplement: Control (microcrystalline cellulose)microcrystalline cellulose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and females 18-65 years old
- Generally healthy
- Able to provide informed consent
- Recent positive COVID-19 test (per RT-PCR Test)*
Key exclusion criteria (10 listed)
- Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, malignancy, HIV, lung conditions or chronic asthma)
- Serious mood disorders, neurological disorders such as MS, or cognitive damage
- Active smokers and/or nicotine or drug abuse
- Active, regular marijuana or other cannabinoid use, other street/recreational drug use
- Chronic past and/or current alcohol use (>14 alcoholic drinks week)
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 |
|---|---|---|
| palmitoylethanolamideAlso: Levagen4 tablets taken daily (2 in the am and 2 in the pm) | Dietary supplement | palmitoylethanolamide |
| PlaceboAlso: microcrystalline cellulose4 tablets taken daily (2 in am and 2 in pm) | Dietary supplement | Placebo |
| CurcuminAlso: Hydrocurc500 mg HydroCurc® twice a day | Dietary supplement | HydroCurc |
| Control (microcrystalline cellulose)Also: microcrystalline cellulose2 tablets taken daily | Dietary supplement | Control |
Primary outcome
IL6 concentration
Time frame: change from baseline at day 28
interleukin-6
6 secondary outcomes
serum CRP concentration
Time frame: change from baseline at day 28
serum ferritin concentration
Time frame: change from baseline at day 28
serum ICAM concentration
Time frame: change from baseline at day 28
serum NFk-beta concentration
Time frame: change from baseline at day 28
serum white blood cell differential
Time frame: change from baseline at day 28
serum p-selectin concentration
Time frame: change from baseline at day 28
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 8 Mar 2023.
- Derived from this study: PubMed 36084236Fessler SN, Liu L, Chang Y, Yip T, Johnston CS. Palmitoylethanolamide Reduces Proinflammatory Markers in Unvaccinated Adults Recently Diagnosed with COVID-19: A Randomized Controlled Trial. J Nutr. 2022 Oct 6;152(10):2218-2226. doi: 10.1093/jn/nxac154.
- 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 palmitoylethanolamide and Curcumin in people with Inflammation and COVID19, 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 10 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 8 Mar 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?
IL6 concentration (time frame: change from baseline at day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912921, which also lists 1 linked publication.
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 8 Mar 2023.