HealthyNCT05548595

A Study to Evaluate the Impact of a Nutritional Product on Cognition in Healthy Teenagers

A study testing Investigational in people with Healthy, run by Hong Kong Prospect Group Co. Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Nutritional products such as spearmint extract, alpha-glyceryl phosphoryl choline and phosphatidylserine may have anti-oxidative and anti-inflammatory effect that may be effective in improving cognition. This study aims to evaluate the impact of a nutritional product on cognition in healthy teenagers. Read more about this study

Who is it for?: Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Investigational
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited States
Study dates: 29 Jan 2022to 4 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 12 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Middle, high school, or college students who are 12 to 18 years of age (inclusive).
In good general health (no active or uncontrolled diseases, infections, or conditions) and able to swallow the study products (tablets).
Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening.
Individuals of childbearing potential must practice a medically acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
use for at least 3 months prior to the first dose of study product: hormonal contraceptives including oral contraceptives, hormone birth control patch (e.g., Ortho Evra), vaginal contraceptive ring (e.g., NuvaRing), injectable contraceptives (e.g., Depo-Provera, Lunelle), or hormone implant (e.g., Norplant System); or
use for at least 1 month prior to the first dose of study product: double-barrier method, intrauterine devices or

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vasectomy of partner at least 6 months prior to the first dose of study product Individuals of the potential to get others pregnant must use condoms or other medically acceptable methods to prevent pregnancy throughout the study.
Agree to refrain from treatments listed in protocol in the defined timeframe.
Participant and participant's legally authorized representative (LAR, if applicable) are willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent and assent, be able to understand and perform the assessments, carry out all study-related procedures, communicate effectively with the study staff, and agree to allow evaluations related to cognitive function.

Who cannot join

Female or transgendered male participants who are lactating, pregnant or planning to become pregnant during the study.
History of diagnosis of depression, other psychiatric disorders (e.g., attention deficit hyperactivity disorder [ADHD]), or any related condition within the past five years.
History of heart disease/cardiovascular disease, uncontrolled hypertension (i.e., ≥130 mmHg systolic and/or ≥80 mmHg diastolic), kidney disease (dialysis or renal failure), hepatic impairment, Type I or Type II diabetes, unstable thyroid disease, immune disorder (i.e., HIV/AIDS), or cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
Use of concomitant treatments listed in protocol within the defined timeframe.
Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data.

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History of alcohol or substance abuse in the 12 months prior to screening.
Receipt or use of test product(s) in another research study within 28 days prior to baseline (Visit 2) or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
Siblings or family members living at the same address if there is already a participant from the same family/address.
Any other active or unstable medical conditions or use of medications/supplements/ therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.

Trial locations and contacts

1 site in 1 country.

United States1 site

Nova Southeastern University
Fort Lauderdale, Florida, 33314

Other trials in United States

About this study

Official title: A Prospective, Randomized, Proof of Concept Study to Evaluate the Impact of a Nutritional Product on Cognition in Healthy Teenagers

Read the detailed description

There is a growing interest in the nootropic properties of nutritional supplements, especially for improving cognitive processes such as attention, perception, evaluation, and working memory. Spearmint extract, alpha-glyceryl phosphoryl choline, and pyrroloquinoline quinone have antioxidative properties that may contribute to cognitive function, and spearmint extract has demonstrated attention-enhancing effects in young adults and memory-improving effects in elderly population. Phosphatidylserine is a phospholipid found abundantly in the brain that has also been evidenced to be effective in improving cognition.

This randomized, double-blind study will be conducted to determine whether a nutritional supplement containing spearmint extract, phosphatidylserine, alpha-glyceryl phosphoryl choline, and pyrroloquinoline quinone ("Brain Doctors Formula Mega Brain Boost") is safe and effective in improving cognitive function in healthy participants aged 12 to 18 years.

Conditions: Healthy
Being tested: Investigational, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

InvestigationalDietary supplement
Also called BDF Mega Brain Boost
2 tablets are taken with water around the same time every day, ideally after a meal
PlaceboOther
2 tablets are taken with water around the same time every day, ideally after a meal

Study groups in NCT05548595
Study group	Role	What they receive
Investigational	Experimental	Active ingredients (per tablet): • NeumentixTM Phenolic Complex K110-42: * 450 mg Spearmint extract (Mentha spicata) * 100 mg Alpha-Glyceryl Phosphoryl Choline * 50 mg Phosphatidylserine (Sharp PS®) * 10 mg Pyrroloquinoline quinone Inactive ingredients (per tablet): * Microcrystalline cellulose * Maltodextrin * Hardened rapeseed fat * Magnesium salts from fatty acids (palm oil free) * Silicon dioxide * Glycerin * Hydroxypropyl methylcellulose Receives: Dietary Supplement: Investigational
Placebo	Placebo comparator	Active ingredients (per tablet): N/A Inactive ingredients (per tablet): * Lactose monohydrate * Magnesium stearate * Microcrystalline cellulose Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the impact of test product on the executive cognitive function in healthy adolescents within the group and when compared to the placebo
Change from baseline in national institute of health (NIH) Toolbox Dimension Change Card Test (aged 12+ version) after 3 and 6 weeks. Dimensional Change Card Sort Test is a measure of cognitive flexibility. The scoring range is provided as an age-corrected normative score. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
Measured: after 3 and 6 weeks
To determine the impact of test product on the attention and executive cognitive function in healthy adolescents within the group and when compared to the placebo
Change from baseline in NIH Toolbox Flanker Inhibitory Control and Attention Test (12+) after 3 and 6 weeks. The Flanker task measures both attention and inhibitory control. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
Measured: after 3 and 6 weeks
To determine the impact of test product on the cognitive processing speed of healthy adolescents within the group and when compared to the placebo
Change from baseline in NIH Toolbox Pattern Comparison Speed Test after 3 and 6 weeks. This test measures speed of cognitive processing. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
Measured: after 3 and 6 weeks
To determine the impact of test product on the working memory of healthy adolescents within the group and when compared to the placebo
Change from baseline in the Symmetry Span Task after 3 and 6 weeks. The symmetry span task is a measure of working memory capacity. Scores on the task range from 0-42 with higher scores representing greater working memory capacity
Measured: after 3 and 6 weeks
To determine the impact of test product on self reported mind wandering of healthy adolescents within the group and when compared to the placebo
Change from Week 1 in the self assessment of mind wandering, as captured in a study daily diary, after 3 and 6 weeks by using the The Mind Wandering Questionnaire. The Mind Wandering Questionnaire is a retrospective measure of mind wandering in a everyday life. A scoring range is between 1-6. Higher scores on this scale represent greater levels of mind wandering experienced
Measured: after 3 and 6 weeks
To assess the safety and tolerability of the test product in healthy adolescents
Counting the number of adverse events over the study period
Measured: 6 weeks
To assess the safety and tolerability of the test product in healthy adolescents
Assessing the type of adverse events (non serious or serious) over the study period
Measured: 6 weeks
To assess the safety and tolerability of the test product in healthy adolescents
Assessing the severity of adverse events (mild, moderate, severe) over the study period
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 20224 Apr 2022

First posted21 Sep 2022
Study start29 Jan 2022
Primary completion4 Apr 2022
Study completion4 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.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomization at 1:1 ratio for active or placebo
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05548595
Sponsor's protocol ID: H02-21-01-T0018
Status last verified: Sep 2022
First submitted: 17 Sep 2022
Last updated: 21 Sep 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Proof of Concept Study to Evaluate the Impact of a Nutritional Product on Cognition in Healthy Teenagers
ClinicalTrials.gov ID: NCT05548595
Acronym / sponsor ID: H02-21-01-T0018
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Hong Kong Prospect Group Co. LimitedIndustry (pharma, biotech, devices)
Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study start: 29 Jan 2022 (actual)
Primary completion: 4 Apr 2022 (actual)
Study completion: 4 Apr 2022 (actual)
First posted: 21 Sep 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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Randomization at 1:1 ratio for active or placebo

Arm	Type	Receives
Investigational	Experimental	Dietary Supplement: InvestigationalActive ingredients (per tablet): • NeumentixTM Phenolic Complex K110-42: * 450 mg Spearmint extract (Mentha spicata) * 100 mg Alpha-Glyceryl Phosphoryl Choline * 50 mg Phosphatidylserine (Sharp PS®) * 10 mg Pyrroloquinoline quinone Inactive ingredients (per tablet): * Microcrystalline cellulose * Maltodextrin * Hardened rapeseed fat * Magnesium salts from fatty acids (palm oil free) * Silicon dioxide * Glycerin * Hydroxypropyl methylcellulose
Placebo	Placebo comparator	Other: PlaceboActive ingredients (per tablet): N/A Inactive ingredients (per tablet): * Lactose monohydrate * Magnesium stearate * Microcrystalline cellulose

Who may qualify

Ages: 12 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (9 listed)

Middle, high school, or college students who are 12 to 18 years of age (inclusive).
In good general health (no active or uncontrolled diseases, infections, or conditions) and able to swallow the study products (tablets).
Have normal (or acceptable to the investigator) vital signs (blood pressure and heart rate) at screening.
Individuals of childbearing potential must practice a medically acceptable form of birth control for a certain timeframe prior to the first dose of study product and throughout the study, including:
Agree to refrain from treatments listed in protocol in the defined timeframe.

Key exclusion criteria (10 listed)

Female or transgendered male participants who are lactating, pregnant or planning to become pregnant during the study.
History of diagnosis of depression, other psychiatric disorders (e.g., attention deficit hyperactivity disorder [ADHD]), or any related condition within the past five years.
History of heart disease/cardiovascular disease, uncontrolled hypertension (i.e., ≥130 mmHg systolic and/or ≥80 mmHg diastolic), kidney disease (dialysis or renal failure), hepatic impairment, Type I or Type II diabetes, unstable thyroid disease, immune disorder (i.e., HIV/AIDS), or cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening visit.
Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
Use of concomitant treatments listed in protocol within the defined timeframe.

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
InvestigationalAlso: BDF Mega Brain Boost2 tablets are taken with water around the same time every day, ideally after a meal	Dietary supplement	Investigational
Placebo2 tablets are taken with water around the same time every day, ideally after a meal	Other	Placebo

Primary outcome

To determine the impact of test product on the executive cognitive function in healthy adolescents within the group and when compared to the placebo
Time frame: after 3 and 6 weeks
Change from baseline in national institute of health (NIH) Toolbox Dimension Change Card Test (aged 12+ version) after 3 and 6 weeks. Dimensional Change Card Sort Test is a measure of cognitive flexibility. The scoring range is provided as an age-corrected normative score. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
To determine the impact of test product on the attention and executive cognitive function in healthy adolescents within the group and when compared to the placebo
Time frame: after 3 and 6 weeks
Change from baseline in NIH Toolbox Flanker Inhibitory Control and Attention Test (12+) after 3 and 6 weeks. The Flanker task measures both attention and inhibitory control. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
To determine the impact of test product on the cognitive processing speed of healthy adolescents within the group and when compared to the placebo
Time frame: after 3 and 6 weeks
Change from baseline in NIH Toolbox Pattern Comparison Speed Test after 3 and 6 weeks. This test measures speed of cognitive processing. A score of 100 indicates performance that is at the national average for the participant's age. A score of 115 or 85 would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants
To determine the impact of test product on the working memory of healthy adolescents within the group and when compared to the placebo
Time frame: after 3 and 6 weeks
Change from baseline in the Symmetry Span Task after 3 and 6 weeks. The symmetry span task is a measure of working memory capacity. Scores on the task range from 0-42 with higher scores representing greater working memory capacity
To determine the impact of test product on self reported mind wandering of healthy adolescents within the group and when compared to the placebo
Time frame: after 3 and 6 weeks
Change from Week 1 in the self assessment of mind wandering, as captured in a study daily diary, after 3 and 6 weeks by using the The Mind Wandering Questionnaire. The Mind Wandering Questionnaire is a retrospective measure of mind wandering in a everyday life. A scoring range is between 1-6. Higher scores on this scale represent greater levels of mind wandering experienced
To assess the safety and tolerability of the test product in healthy adolescents
Time frame: 6 weeks
Counting the number of adverse events over the study period
To assess the safety and tolerability of the test product in healthy adolescents
Time frame: 6 weeks
Assessing the type of adverse events (non serious or serious) over the study period
To assess the safety and tolerability of the test product in healthy adolescents
Time frame: 6 weeks
Assessing the severity of adverse events (mild, moderate, severe) over the study period

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 21 Sep 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.

Jaime Tartar, Ph.D. principal investigator

Nova Southeastern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Investigational in people with Healthy, run by Hong Kong Prospect Group Co. Limited 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 9 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: finished, as of the sponsor's last update on 21 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 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?

To determine the impact of test product on the executive cognitive function in healthy adolescents within the group and when compared to the placebo (time frame: after 3 and 6 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05548595.

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 21 Sep 2022.