HealthyNCT05041192
The Effects of Synaquell on Brain Function
A study testing Synaquell in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function. Read more about this study
- Who is it for?
- Ages 18 to 21 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Synaquell
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2021to 22 Apr 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 21 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age or greater.
- Fluent English speakers.
- Medically cleared to play ice hockey.
Who cannot join
- An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).
- Clinically documented hearing issues.
- In-ear hearing aid or cochlear implant.
- Implanted pacemaker or defibrillator.
- Metal or plastic implants in skull.
- Lack of verbal fluency in the English language.
Show all 9Show fewer
- History of seizures.
- Allergy to rubbing alcohol or EEG gel.
- Unhealthy scalp.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
Read the detailed description
Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.
- Conditions
- Healthy
- Being tested
- Synaquell, Placebo
- Keywords
- Ice Hockey, Cognitive Function, Cognition, Brain, Supplement, Contact Sport Athletes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynaquellDietary supplement
7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).
PlaceboDietary supplement
7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams).
| Study group | Role | What they receive |
|---|---|---|
| Synaquell Group | Experimental | Subjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season. Receives: Dietary Supplement: Synaquell |
| Placebo Group | Placebo comparator | Subjects will receive the placebo twice-daily, during the hockey season. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain vital signs
Obtained by EEG recording of N100, P300, N400 amplitudes and latencies. Increased amplitudes are indicative of larger signals and increased latencies are indicative of slower responses.
Measured: Baseline, Postseason (approximately 6 months)
Change in blood biomarker
Neurofilament light chain (NfL) blood serum levels.
Measured: Baseline, Postseason (approximately 6 months)
Secondary outcomes (1)
Change in King-Devick Test (KDT) scores
A rapid number-naming test that requires individuals to read 3 numbered cards a loud as fast as possible, the resulting time is the KDT score.
Measured: Baseline, Postseason (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start3 Sep 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
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.
- More trials run by Mayo ClinicThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- HealthTech Connex Inc., Thorne HealthTech, Inc
- Responsible party
- Principal investigator, Michael J. Stuart, Mayo Clinic
- Investigators
- Michael J Stuart, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041192
- Sponsor's protocol ID
- 21-004746
- Status last verified
- Nov 2022
- First submitted
- 2 Sep 2021
- Last updated
- 29 Nov 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 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players
- ClinicalTrials.gov ID
- NCT05041192
- Acronym / sponsor ID
- 21-004746
- Conditions
- Healthy
- Keywords
- Ice Hockey, Cognitive Function, Cognition, Brain, Supplement, Contact Sport Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- HealthTech Connex Inc., Thorne HealthTech, Inc
- Study start
- 3 Sep 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 10 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.
The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.
Detailed description
Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synaquell Group | Experimental | Dietary Supplement: SynaquellSubjects will receive the dietary supplement, Synaquell, twice-daily during the hockey season. |
| Placebo Group | Placebo comparator | Dietary Supplement: PlaceboSubjects will receive the placebo twice-daily, during the hockey season. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 years of age or greater.
- Fluent English speakers.
- Medically cleared to play ice hockey.
Key exclusion criteria (9 listed)
- An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).
- Clinically documented hearing issues.
- In-ear hearing aid or cochlear implant.
- Implanted pacemaker or defibrillator.
- Metal or plastic implants in skull.
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 |
|---|---|---|
| Synaquell7.9 grams of Synaquell are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams). | Dietary supplement | Synaquell Group |
| Placebo7.9 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day. The daily amount taken by each participant is (15.8 grams). | Dietary supplement | Placebo Group |
Primary outcome
Change in brain vital signs
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of N100, P300, N400 amplitudes and latencies. Increased amplitudes are indicative of larger signals and increased latencies are indicative of slower responses.
Change in blood biomarker
Time frame: Baseline, Postseason (approximately 6 months)
Neurofilament light chain (NfL) blood serum levels.
1 secondary outcome
Change in King-Devick Test (KDT) scores
Time frame: Baseline, Postseason (approximately 6 months)
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 29 Nov 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
Michael J Stuart, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synaquell in people with Healthy, run by Mayo Clinic 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 3 inclusion and 9 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 29 Nov 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. 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?
Change in brain vital signs (time frame: Baseline, Postseason (approximately 6 months)). The study lists 2 primary outcomes in all. 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 29 Nov 2022.