FatiguePL-PC19NCT05311852
Effects of PEA-LUT on Frontal Lobe Functions and GABAergic Transmission in Long-Covid Patients
A study testing palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT) in people with Fatigue and Cognitive Deficit, run by Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy at 1 site in Italy.
Trial summary
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue, Cognitive Deficit, COVID-19
- What is being tested?
- palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteItaly
- Study dates
- 16 Aug 2021to 15 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab;
- subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day;
- mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission;
- complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection.
Who cannot join
- prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions;
- clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease;
- anaemia;
- current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Palmitoylethanolamide Co-ultramicronized With Luteoline (Pea-lut) on Frontal Lobe Functions and GABAergic Transmission in Long Covid Patients. An 8-week Randomized Controlled Trial.
The study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid
Read the detailed description
Aim of this study was testing the possible therapeutic effects of an 8-week therapy with PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive complaints and fatigue.
- Conditions
- Fatigue, Cognitive Deficit, COVID-19, Neurophysiologic Abnormality
- Being tested
- palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT), Placebo
- Keywords
- fatigue, cognitive deficits, post-covid19 syndrome
- Medical subject headings
- Fatigue, Cognition Disorders, COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)Dietary supplement
assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks
PlaceboDietary supplement
assumption of a placebo product 2 time/day for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| PEA-LUT | Experimental | patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks Receives: Dietary Supplement: palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT) |
| Placebo | Placebo comparator | patients were required to assume granulated placebo, 2 time/day for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in % of test amplitude in LICI 100
changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected
Measured: LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration
Secondary outcomes (2)
changes in % of test amplitude in SAI 20
changes % of test amplitude in short-latency afferent inhibition, to evaluate M1 inhibition induced by sensory afferents, are expected
Measured: SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration
change in LTP-like cortical plasticity
change of MEP modulation after intermittent theta burst stimulation (iTBS)
Measured: LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start16 Aug 2021
- Primary completion15 Feb 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
- Sponsor type
- Research network
- Collaborators
- I.R.C.C.S. Fondazione Santa Lucia
- Responsible party
- Principal investigator, Paola Ortelli, Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy
- Investigators
- Leopold Saltuari, Md, Study director, Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311852
- Sponsor's protocol ID
- PEA-LUT-in-Post-Covid-19
- Acronym
- PL-PC19
- Status last verified
- Sep 2022
- First submitted
- 30 Mar 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Palmitoylethanolamide Co-ultramicronized With Luteoline (Pea-lut) on Frontal Lobe Functions and GABAergic Transmission in Long Covid Patients. An 8-week Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05311852
- Acronym / sponsor ID
- PL-PC19 / PEA-LUT-in-Post-Covid-19
- Conditions
- Fatigue, Cognitive Deficit, COVID-19, Neurophysiologic Abnormality
- Keywords
- fatigue, cognitive deficits, post-covid19 syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) ItalyResearch network
- Collaborators
- I.R.C.C.S. Fondazione Santa Lucia
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 5 Apr 2022 (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 study explore the efficacy of PEA-LUT in patients suffering from neurological symptoms of Long-Covid
Detailed description
Aim of this study was testing the possible therapeutic effects of an 8-week therapy with PEA-LUT on GABAB-ergic neurotransmission, LTP-like synaptic plasticity, indexed with transient potentiation of motor evoked potentials (MEP) amplitude after repetitive TMS given as intermittent theta burst stimulation (iTBS) in long COVID patients with cognitive complaints and fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized and assigned to one of two or more groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| PEA-LUT | Experimental | Dietary Supplement: palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)patients were required to assume granulated PEA-LUT 700/70 mg, 2 time/day for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebopatients were required to assume granulated placebo, 2 time/day for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- previous diagnosis of SARS-CoV-2 infection confirmed through detection of virus RNA by polymerase chain reaction (PCR) testing of a nasopharyngeal swab;
- subsequent recovery from infection as defined by two consecutive negative PCR tests separated by at least a day;
- mild form of COVID-19 (symptoms may include fever, cough, sore throat, malaise, myalgia, anorexia, nausea, diarrhoea, anosmia and ageusia) without necessitating hospital admission;
- complaints of cognitive difficulties and/or sense of fatigue, persisting after SARS-CoV-2 infection.
Key exclusion criteria (4 listed)
- prior or concurrent diagnosis of neurological, psychiatric, endocrine, metabolic or cardiopulmonary conditions;
- clinical and/or radiological evidence of COVID-19 related pneumonia during the active phase of the disease;
- anaemia;
- current pharmacological treatment with corticosteroids, antihistamines, antihypertensives, diuretics, antidepressants, anxiolytic or hypnotic drugs at the time of study
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 |
|---|---|---|
| palmitoylethanolamide co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT)assumption of the product at dosage of 700/70 mg 2 time/day for 8 weeks | Dietary supplement | PEA-LUT |
| Placeboassumption of a placebo product 2 time/day for 8 weeks | Dietary supplement | Placebo |
Primary outcome
changes in % of test amplitude in LICI 100
Time frame: LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration
changes % of test amplitude in long-interval intracortical inhibition, indexing intracortical GABAB-ergic, transmission, are expected
2 secondary outcomes
changes in % of test amplitude in SAI 20
Time frame: SAI 20 was assessed two times, at enrollment and after 8 weeks of treatment duration
change in LTP-like cortical plasticity
Time frame: LTP-like cortical plasticity was assessed at two times, at enrollment and after 8 weeks of treatment duration
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 26 Sep 2022.
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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.
Leopold Saltuari, Md study director
Department of Neurorehabiliation - Hospital of Vipiteno-Sterzing
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 co-ultramicronized with antioxidant flavonoid luteolin (PEA-LUT) in people with Fatigue and Cognitive Deficit, run by Department of Neurorehabilitation, Hospital of Vipiteno-Sterzing (BZ) Italy at 1 site in Italy.
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 26 Sep 2022. 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 Italy. 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?
changes in % of test amplitude in LICI 100 (time frame: LICI 100 was assessed two times, at enrollment and after 8 weeks of treatment duration). 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 26 Sep 2022.