Phase
Condition
Brain Function
Treatment
Placebo
Kids Plus Multi & Omega
Clinical Study ID
Ages 4-17 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females 4-17 years of age, inclusive
Females of child-bearing potential must have a negative screening urine pregnancytest and agree to use a medically approved method of birth control for the durationof the study. All hormonal birth control must have been in use for a minimum ofthree months. Acceptable methods of birth control include:
Hormonal contraceptives including oral contraceptives, hormone birth controlpatch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectablecontraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
Double-barrier method
Intrauterine devices
Non-heterosexual lifestyle and agrees to use contraception if planning onchanging to heterosexual partner(s)
Vasectomy of partner at least 6 months prior to screening
Abstinence and agrees to use contraception if planning to become sexuallyactive during the study
Enrolled in and currently attending school at baseline and for the duration of thestudy period
Willing to complete evaluations, measurements, questionnaires and diaries duringeach clinic visit
Agrees to avoid eating or moderate-vigorous exercise for one hour prior to clinicvisits
Agrees to maintain current lifestyle habits (diet, physical activity, medications,supplements, and sleep) as much as possible throughout the study and avoid takingnew supplements
A care provider who can reliably bring the participant to all study visits; theparticipant's primary caregiver must be willing and able to complete thequestionnaires as needed for all visits
The child and the child's parent(s) or legal guardian(s) have given voluntary,written, informed assent and consent, respectively, for their child to participatein the study
Healthy as determined by medical history as assessed by Qualified Investigator (QI)
Exclusion
Exclusion Criteria:
Individuals who are pregnant, breast feeding, or planning to become pregnant duringthe study
Allergy, sensitivity, or intolerance to the investigational product or placeboingredients
Previous diagnosis or treatment of a significant neuropsychological condition and/orcognitive impairment (e.g., Schizophrenia, bipolar disorder, post-traumatic stressdisorder, brain injury, neurodegenerative disease, infections, insomnia, depression,epileptic or other seizure-related disorders) that could interfere with studyparticipation as assessed by the QI
Unable to communicate or cooperate due to language problems, learning disability,poor mental development, or impaired cerebral functions as assessed by the QI
Previous diagnosis of Attention-deficit hyperactivity disorder (ADHD)
Previous diagnosis of visual (including color blindness/weakness) or hearingimpairment that may impact task performance as assessed by the QI
Currently experiencing major social/family stressors as confirmed by the child'sparent or legal guardian (s)
History or presence of a clinically relevant cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal condition whichaffects absorption, or pancreatic disorders, as assessed by the QI
Cancer, except skin basal cell carcinoma completely excised with no chemotherapy orradiation with a follow up that is negative. Volunteers with cancer in fullremission for more than five years after diagnosis are acceptable
Individuals with an autoimmune disease or are immune compromised
Use of cannabinoid, tobacco or nicotine-containing products, or alcohol consumption
Alcohol or drug abuse within the last 12 months
Current use of prescribed and/or over-the-counter (OTC) medications, supplements,and/or consumption of food/drinks that may impact the efficacy of theinvestigational product (Sections 7.3.1 and 7.3.2)
Employees/children of employees of study sponsor or research organization
Participation in other clinical research studies 30 days prior to baseline, asassessed by the QI
Parent or guardian who are unable to give informed consent
Any other condition or lifestyle factor, that, in the opinion of the QI, mayadversely affect the participant's ability to complete the study or its measures orpose significant risk to the participant
Study Design
Study Description
Connect with a study center
KGK Science Inc.
London, Ontario N6B3L1
CanadaActive - Recruiting
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