HealthyNCT04556032
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
A study testing L-Ergothioneine 10 mg/d and L-Ergothioneine 25 mg/d in people with Healthy, run by Midwest Center for Metabolic and Cardiovascular Research at 1 site in United States.
Trial summary
The objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women. Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Healthy
- What is being tested?
- L-Ergothioneine 10 mg/d and L-Ergothioneine 25 mg/d
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2020to 30 Oct 2020
- 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 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals 55-79 years of age.
- Body mass index (BMI) 18.50-34.99 kg/m2
- Non-smoker defined as no smoking for at least 6 months.
- Willing to limit alcohol and caffeine consumption
- Generally, in good health based on medical history and laboratory assessments
- Agree to avoid consumption of mushrooms and excluded medications/supplements for the duration of the study
- Willing to commit to all study procedures
Who cannot join
- Consumption of mushrooms more than once per week
- History or presence of a psychiatric or neurologic disease including, but not limited to, epilepsy, cerebrovascular disturbance, traumatic injury, or clinically diagnosed dementia or Alzheimer's disease.
- Scores ≥17 on the Beck Depression Inventory
- History of cardiovascular complications, type 1 or type 2 diabetes mellitus, uncontrolled hypertension, or any other clinically significant disorder
- History of cancer except non-melanoma skin cancer or carcinoma in situ of the cervix within the past 2 years
- Use of any product containing marijuana (THC) and/or cannabidiol (CBD) including oral consumption, inhalation, \& other
Show all 10Show fewer
- Any intolerance to any components of the study products
- Exposure to any non-registered drug product within the past 30 days
- History of drug or alcohol abuse
- Considered unfit for any reason as determined by the principal investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Great Lakes Clinical Trials
Chicago, Illinois, 60640
About this study
Official title: A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
The objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women.
Read the detailed description
This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of one screening (visit 1a, week 0), one baseline visit (visit 1b, week 0), and three treatment visits (visits 2, 3, and 4; weeks 4, 8, and 16).
- Conditions
- Healthy
- Being tested
- L-Ergothioneine 10 mg/d, L-Ergothioneine 25 mg/d, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-Ergothioneine 10 mg/dDietary supplement
L-Ergothioneine 10 mg/d
L-Ergothioneine 25 mg/dDietary supplement
L-Ergothioneine 25 mg/d
PlaceboOther
0 mg/d L-Ergothioneine
| Study group | Role | What they receive |
|---|---|---|
| L-Ergothioneine 10 mg/d | Experimental | Participants will receive L-Ergothioneine 10 mg capsule orally once daily for 16 weeks. Receives: Dietary Supplement: L-Ergothioneine 10 mg/d |
| L-Ergothioneine 25 mg/d | Experimental | Participants will receive L-Ergothioneine 25 mg capsule orally once daily for 16 weeks. Receives: Dietary Supplement: L-Ergothioneine 25 mg/d |
| Placebo | Placebo comparator | Participants will receive placebo orally once daily for 16 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
Measured: Baseline to Week 16
Secondary outcomes (4)
Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
Measured: Baseline to weeks 4 and 8
Changes in standard scores for domains relating to memory, attention, and executive function from the Central Nervous System Vital Signs (CNS-VS) Test Battery
Measured: Baseline to weeks 4, 8 and 16
Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)
Measured: Baseline to weeks 4, 8 and 16
Changes in mood based on Profile of Mood States Questionnaire (POMS)
Measured: Baseline to weeks 4, 8 and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start9 Sep 2020
- Primary completion30 Oct 2020
- Study completion30 Oct 2020
Why it stopped: Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Blue California
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556032
- Sponsor's protocol ID
- MB-2011
- Status last verified
- Sep 2020
- First submitted
- 9 Sep 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Randomized, Double-blind Trial to Assess the Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
- ClinicalTrials.gov ID
- NCT04556032
- Acronym / sponsor ID
- MB-2011
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Blue California
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 21 Sep 2020 (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 objective of this study is to assess the effects of ergothioneine at two doses, compared to placebo, on cognition, mood, and sleep in healthy adult men and women.
Detailed description
This will be a placebo-controlled, randomized, double-blind, parallel-arm trial. The study will consist of one screening (visit 1a, week 0), one baseline visit (visit 1b, week 0), and three treatment visits (visits 2, 3, and 4; weeks 4, 8, and 16).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| L-Ergothioneine 10 mg/d | Experimental | Dietary Supplement: L-Ergothioneine 10 mg/dParticipants will receive L-Ergothioneine 10 mg capsule orally once daily for 16 weeks. |
| L-Ergothioneine 25 mg/d | Experimental | Dietary Supplement: L-Ergothioneine 25 mg/dParticipants will receive L-Ergothioneine 25 mg capsule orally once daily for 16 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive placebo orally once daily for 16 weeks. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals 55-79 years of age.
- Body mass index (BMI) 18.50-34.99 kg/m2
- Non-smoker defined as no smoking for at least 6 months.
- Willing to limit alcohol and caffeine consumption
- Generally, in good health based on medical history and laboratory assessments
Key exclusion criteria (10 listed)
- Consumption of mushrooms more than once per week
- History or presence of a psychiatric or neurologic disease including, but not limited to, epilepsy, cerebrovascular disturbance, traumatic injury, or clinically diagnosed dementia or Alzheimer's disease.
- Scores ≥17 on the Beck Depression Inventory
- History of cardiovascular complications, type 1 or type 2 diabetes mellitus, uncontrolled hypertension, or any other clinically significant disorder
- History of cancer except non-melanoma skin cancer or carcinoma in situ of the cervix within the past 2 years
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 |
|---|---|---|
| L-Ergothioneine 10 mg/dL-Ergothioneine 10 mg/d | Dietary supplement | L-Ergothioneine 10 mg/d |
| L-Ergothioneine 25 mg/dL-Ergothioneine 25 mg/d | Dietary supplement | L-Ergothioneine 25 mg/d |
| Placebo0 mg/d L-Ergothioneine | Other | Placebo |
Primary outcome
Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
Time frame: Baseline to Week 16
4 secondary outcomes
Changes in the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery
Time frame: Baseline to weeks 4 and 8
Changes in standard scores for domains relating to memory, attention, and executive function from the Central Nervous System Vital Signs (CNS-VS) Test Battery
Time frame: Baseline to weeks 4, 8 and 16
Changes in sleep quality based on Leeds Sleep Evaluation Questionnaire (LSEQ)
Time frame: Baseline to weeks 4, 8 and 16
Changes in mood based on Profile of Mood States Questionnaire (POMS)
Time frame: Baseline to weeks 4, 8 and 16
Results and safety
The study was stopped early (reason given: Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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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.
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 L-Ergothioneine 10 mg/d and L-Ergothioneine 25 mg/d in people with Healthy, run by Midwest Center for Metabolic and Cardiovascular Research 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 7 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: stopped early, as of the sponsor's last update on 4 Nov 2020. 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 was stopped early (reason given: Sponsor terminated study due to unforeseen recruitment circumstances amidst the COVID19 pandemic.). Results are not available in the source record.
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 the composite memory standard score from the Central Nervous System Vital Signs (CNS-VS) Test Battery (time frame: Baseline to Week 16). 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 4 Nov 2020.