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

NCT05548595 | Completed

• 1 other identifier: H02-21-01-T0018
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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

  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

  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

  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

  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

  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

  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

  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

  6 weeks

Study Arms (2)

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

Dietary Supplement: Investigational

Placebo

PLACEBO COMPARATOR

Active ingredients (per tablet): N/A Inactive ingredients (per tablet): * Lactose monohydrate * Magnesium stearate * Microcrystalline cellulose

Other: Placebo

Interventions

Investigational DIETARY_SUPPLEMENT

2 tablets are taken with water around the same time every day, ideally after a meal

Also known as: BDF Mega Brain Boost

Investigational

Placebo OTHER

2 tablets are taken with water around the same time every day, ideally after a meal

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Hong Kong Prospect Group Co. Limited: lead
• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator

Study Sites (1)

Nova Southeastern University

Fort Lauderdale, Florida, 33314, United States

Location

Study Officials

• Jaime Tartar, Ph.D.

  Nova Southeastern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization at 1:1 ratio for active or placebo

Study Record Dates

• First Submitted: September 17, 2022
• First Posted: September 21, 2022
• Study Start: January 29, 2022
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)