HealthyNCT05498818
The Effects of Synaquell on Brain Function of Ice Hockey Players
A study testing Synaquell in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy 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
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 14 Mar 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Fluent English speakers
- Medically cleared to play ice hockey
Who cannot join
- An allergy to the ingredients of SynaquellTM or the placebo
- 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
- History of seizures
- Allergy to rubbing alcohol or EEG gel
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 Youth Ice Hockey Players
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.
Read the detailed description
This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King Devick).
- 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 (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams).
PlaceboDietary supplement
7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| Synaquell Male Group | Experimental | Male youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. Receives: Dietary Supplement: Synaquell |
| Placebo Male Group | Placebo comparator | Male youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. Receives: Dietary Supplement: Placebo |
| Synaquell Female Group | Experimental | Female youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. Receives: Dietary Supplement: Synaquell |
| Placebo Female Group | Placebo comparator | Female youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in N100 Amplitude
Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Measured: Baseline, Postseason (approximately 6 months)
Change in N100 Latency
Obtained by EEG recording of N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Measured: Baseline, Postseason (approximately 6 months)
Change in P300 Amplitude
Obtained by EEG recording of P300 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Measured: Baseline, Postseason (approximately 6 months)
Change in P300 Latency
Obtained by EEG recording of P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Measured: Baseline, Postseason (approximately 6 months)
Change in N400 Amplitude
Obtained by EEG recording of N400 potential amplitude. Increased amplitudes are indicative of larger signals.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Measured: Baseline, Postseason (approximately 6 months)
Change in N400 Latency
Obtained by EEG recording of N400 potential latency. Increased latencies are indicative of slower responses.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
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 patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant.
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 posted12 Aug 2022
- Study start3 Nov 2022
- Primary completion14 Mar 2023
- Study completion14 Mar 2023
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
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ORRS Owner, Mayo Clinic
- Investigators
- Michael Stuart, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498818
- Sponsor's protocol ID
- 22-003414
- Status last verified
- Jan 2024
- First submitted
- 2 Aug 2022
- Last updated
- 9 Jan 2024
- 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 Jan 2024. 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 Youth Ice Hockey Players
- ClinicalTrials.gov ID
- NCT05498818
- Acronym / sponsor ID
- 22-003414
- Conditions
- Healthy
- Keywords
- Ice Hockey, Cognitive Function, Cognition, Brain, Supplement, Contact Sport Athletes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 12 Aug 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.
This research is being done to investigate the dietary supplement, Synaquell (TM), for effects on brain function in youth ice hockey players.
Detailed description
This randomized clinical trial will compare a brain health supplement (Synaquell) with placebo in both male and female ice hockey players over the course of an entire season. The repeated measure design will compare pre- and post-season objective brain health parameters, including quantitated EEG (Neurocatch), blood biomarkers and a rapid number naming test (King Devick).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Synaquell Male Group | Experimental | Dietary Supplement: SynaquellMale youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. |
| Placebo Male Group | Placebo comparator | Dietary Supplement: PlaceboMale youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. |
| Synaquell Female Group | Experimental | Dietary Supplement: SynaquellFemale youth hockey players will receive the dietary supplement Synaquell, twice-daily during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. |
| Placebo Female Group | Placebo comparator | Dietary Supplement: PlaceboFemale youth hockey players will receive the placebo twice-daily, during the hockey season. Due to difference in game rules and playing styles, males and females will be treated as two separate arms of the research protocol. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Fluent English speakers
- Medically cleared to play ice hockey
Key exclusion criteria (8 listed)
- An allergy to the ingredients of SynaquellTM or the placebo
- 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 (1 scoop) of Synaquell powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). | Dietary supplement | Synaquell Female Group, Synaquell Male Group |
| Placebo7.9 grams (1 scoop) of placebo powder mixed with 12 ounces of water two times per day for the duration of the sport season. The daily amount taken by each participant is (15.8 grams). The placebo looks, smells, and tastes like Synaquell but does not contain active ingredient. | Dietary supplement | Placebo Female Group, Placebo Male Group |
Primary outcome
Change in N100 Amplitude
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in N100 Latency
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in P300 Amplitude
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of P300 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in P300 Latency
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in N400 Amplitude
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of N400 potential amplitude. Increased amplitudes are indicative of larger signals.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
Change in N400 Latency
Time frame: Baseline, Postseason (approximately 6 months)
Obtained by EEG recording of N400 potential latency. Increased latencies are indicative of slower responses.This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. Changes in brain vital sign scores are depicted within a radar plot format, with the transformation process preserving the essential ERP results but enabling practical, simplified interpretation.
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 9 Jan 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Michael 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 2 inclusion and 8 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 9 Jan 2024. 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 N100 Amplitude (time frame: Baseline, Postseason (approximately 6 months)). The study lists 7 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 9 Jan 2024.