A randomized, double-blind, placebo-controlled clinical study to evaluate influence of LN22203 supplementation on memory, e-sports performance and mood states of young adults.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline to end of the study in scores in
研究概览
简要总结
The purpose of this study to evaluate influence of LN22203 supplementation on memory, e-sports performance and mood states of young adults.. A total of 50 male and female subjects of age between 18 and 30 years will be included in the study. Assessments of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list. The subjects will be assigned to either one of the study groups (LN22203 500mg or placebo) at 1:1 ratio. The participants will be instructed to take one capsule daily in the morning after breakfast for 30days. Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal compositions safety and tolerability. The safety assessements of LN22203 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy male and female e-gamers (18 to 30 years of age with BMI range of 18 to 29 Kg per m2) who plays video games for 5 or more hours per week for 6 months prior to screening.
- •2.Adequate visual and auditory acuity to allow neuropsychological testing.
- •3.Subjects agreed to participate in 20 min e- Sports familiarization session at each visit.
- •4.Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •5.Subject agrees not to start any new supplements including Vitamins (Such as Folate, B12, B6 containing multivitamins) and herbal supplements during the course of the study.
- •6.Willing and able to sign informed consent and complete all tests and procedures as listed in the protocol.
- •7.Has not taken any type of medicine or herbal supplements in the past 3 months related to improve cognition or related functions.
- •8.Free from bipolar disorder and terminal illnesses such as cancer.
- •9.ECG without clinically significant abnormalities.
- •10.Subject should be a literate.
- •11.Results of screening are within normal range or considered not clinically significant by the Principal Investigator.
- •General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimers disease cannot be made by the site physician at the time of the screening visit.
排除标准
- •1.Subjects have a history of cognitive dysfunction.
- •2.Subject have known cardiovascular, metabolic and,or other diseases under the treatment (birth control is allowed).
- •3.Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or haematological illness or unstable medical condition which could interfere with investigational supplement safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.
- •4.Any significant neurologic disease (other than suspected incipient Alzheimers disease), such as Parkinsons disease, stroke, TIAs, multi-infarct dementia, Huntingtons disease, head trauma, chronic CNS infection.
- •5.Clinically significant coagulopathy or vitamin K deficiency within the past two years prior to screening.
- •6.Subjects have known obstructive pulmonary disease or asthma or allergy to excipients of IP.
- •7.Subjects previously diagnosed with dementia or any neurological disease.
- •8.Subjects having post COVID symptoms or underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
- •9.Subjects suffering from severe intrinsic sleep-related disorders such as sleep apnea, restless leg syndrome (RLS), narcolepsy.
- •10.History of major depression or another major psychiatric disorder within the past 6 months.
- •11.History of alcohol or substance abuse or dependence within the past year.
- •12.Subjects have any Sexually transmitted diseases (STD).
- •14.Subjects have abnormal blood pressure (Systolic greater than 140 and Diastolic greater than 100 mmHg).
- •15.Subjects have a recent major surgery or surgery scheduled in the next 4 to 5 weeks.
- •16.Any Abnormal clinical laboratory test results or vital signs considered clinically significant in the opinion of the Investigator.
- •17.Subjects with HIV Positive.
- •18.Indication of inability to make decisions regarding study participation.
结局指标
主要结局
Change from baseline to end of the study in scores in
时间窗: Day1 (baseline) Day7, Day15 and Day 30
Simple reaction time
时间窗: Day1 (baseline) Day7, Day15 and Day 30
次要结局
- 1.Change from baseline to end of the study in Scores of Go-no-Go task.
研究者
Dr CH Amulya
Aditya Multi Speciality Hospital