PharmacokineticsNCT05042674
Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
A study testing Ergothioneine, 25 miligrams and Ergothioneine, 25 miligrams, daily for 1 week in people with Pharmacokinetics, run by Natural Immune Systems Inc at 1 site in United States.
Trial summary
A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Ergothioneine, 25 miligrams and Ergothioneine, 25 miligrams, daily for 1 week
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 5 May 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements
- Willing to maintain a consistent diet and lifestyle routine throughout the study
- Willing to avoid consumption of meals where the predominant ingredients include mushrooms, seafood, and organ meat (liver, heart).*
- Willing to abstaining from exercising on the morning of a study visit
- Willing to abstain from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit
- Willing to abstain from music, candy, gum, computer/cell phone use, during clinic visits.
Who cannot join
- Previous major gastrointestinal surgery
- Active chronic immunological disease
- Currently taking daily OTC medications, prescription pain medications, antipsychotic medications, anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects if the test product, nutritional supplements containing medicinal mushroom extracts
- Diagnose with Type I diabetes, autoimmune disorders
- Getting regular joint injections
- Active severe chronic disease (such as HIV, chronic hepatitis)
Show all 13Show fewer
- Currently experiencing intense stressful events/ life changes
- Currently in intensive athletic training
- Experiencing an unusual sleep routine
- Unwilling to maintain a constant intake of supplements over the duration of the study
- Anxiety about having blood drawn
- Women who are pregnant, nursing, or trying to become pregnant
- Known food allergies to ingredients in test product
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
NIS Labs
Klamath Falls, Oregon, 97601
Gitte Jensen, PhD, 541-884-0112, gitte@nislabs.com
Gitte S Jensen, PhD
About this study
A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.
Read the detailed description
A randomized, cross-over study design will be used to evaluate immune effects of consumption of 25 mg ergothioneine. On the first clinic day, participants will take a placebo with a one week wash out. Following the wash out week, participants will take 25 mg ergothioneine for 7 consecutive days.
- Conditions
- Pharmacokinetics
- Being tested
- Placebo, Ergothioneine, 25 miligrams, Ergothioneine, 25 miligrams, daily for 1 week
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
after a blood draw placebo will be consumed followed by 2 additional blood draws
Ergothioneine, 25 miligramsDietary supplement
after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws
Ergothioneine, 25 miligrams, daily for 1 weekDietary supplement
a blood draw will be administered after a week of consuming 25mg ergothioneine daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily | Other | Participants will consume placebo on first study day, consume 25mg of ergothioneine on second study day, then consume 25mg of ergothioneine daily for 1 week Receives: Dietary Supplement: Placebo; Dietary Supplement: Ergothioneine, 25 miligrams; Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of reduced glutathione
Mean fluorescence
Measured: 2 hours
Secondary outcomes (1)
Change in mitochondrial mass and mitochondrial potential from baseline
Mean fluorescence
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start20 Sep 2021
- Primary completion25 Mar 2023 (estimated)
- Study completion5 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Natural Immune Systems Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitte Jensen, Ph.D., Natural Immune Systems Inc
- Investigators
- Gitte Jensen, PhD, Principal investigator, NIS Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042674
- Sponsor's protocol ID
- NIS174-003
- Status last verified
- Jun 2022
- First submitted
- 4 Sep 2021
- Last updated
- 9 Jun 2022
- 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 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Rapid Antioxidant Protection and Immune Modulating Effects.
- ClinicalTrials.gov ID
- NCT05042674
- Acronym / sponsor ID
- NIS174-003
- Conditions
- Pharmacokinetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Natural Immune Systems IncUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 25 Mar 2023 (estimated)
- Study completion
- 5 May 2023 (estimated)
- First posted
- 13 Sep 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.
A trial on acute antioxidant protection and immune effects when 24 people consume a novel nutraceutical blend compared to a placebo on different test days.
Detailed description
A randomized, cross-over study design will be used to evaluate immune effects of consumption of 25 mg ergothioneine. On the first clinic day, participants will take a placebo with a one week wash out. Following the wash out week, participants will take 25 mg ergothioneine for 7 consecutive days.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily | Other | Dietary Supplement: Placebo, Dietary Supplement: Ergothioneine, 25 miligrams, Dietary Supplement: Ergothioneine, 25 miligrams, daily for 1 weekParticipants will consume placebo on first study day, consume 25mg of ergothioneine on second study day, then consume 25mg of ergothioneine daily for 1 week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements
- Willing to maintain a consistent diet and lifestyle routine throughout the study
- Willing to avoid consumption of meals where the predominant ingredients include mushrooms, seafood, and organ meat (liver, heart).*
- Willing to abstaining from exercising on the morning of a study visit
- Willing to abstain from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit
Key exclusion criteria (13 listed)
- Previous major gastrointestinal surgery
- Active chronic immunological disease
- Currently taking daily OTC medications, prescription pain medications, antipsychotic medications, anti-inflammatory nutritional supplements judged by the study coordinator to negate or camouflage the effects if the test product, nutritional supplements containing medicinal mushroom extracts
- Diagnose with Type I diabetes, autoimmune disorders
- Getting regular joint injections
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 |
|---|---|---|
| Placeboafter a blood draw placebo will be consumed followed by 2 additional blood draws | Dietary supplement | Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily |
| Ergothioneine, 25 miligramsafter a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws | Dietary supplement | Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily |
| Ergothioneine, 25 miligrams, daily for 1 weeka blood draw will be administered after a week of consuming 25mg ergothioneine daily | Dietary supplement | Placebo, Ergothioneine 25mg, Ergothioneine 25mg for 1 week daily |
Primary outcome
Change in level of reduced glutathione
Time frame: 2 hours
Mean fluorescence
1 secondary outcome
Change in mitochondrial mass and mitochondrial potential from baseline
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- 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.
Gitte Jensen, PhD principal investigator
NIS Labs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ergothioneine, 25 miligrams and Ergothioneine, 25 miligrams, daily for 1 week in people with Pharmacokinetics, run by Natural Immune Systems Inc 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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 9 Jun 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gitte Jensen, PhD (541-884-0112, gitte@nislabs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in level of reduced glutathione (time frame: 2 hours). 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 9 Jun 2022.