A Prospective, Randomized, Double-blind, Cross-Over, Placebo-controlled Study to Evaluate the Impact of MA2/24 and Caffeine (Alone or in Combination) vs. Placebo on Mental and Physical Stamina
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 2
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, cross-over clinicalinterventional study. Adult healthy males and/or females, aged between 18and 40 years old and meeting all inclusion and no exclusion criteria will beenrolled in the study after signing a written informed consent. After the informedconsent process, demographic details such as date of birth, sex, ethnicity andrace will be obtained. Medical history including hypertension, diabetes mellitus,chronic liver, gastrointestinal and renal disorders, surgeries, any other clinicallysignificant medical and medication history including dementia will be obtained.Subjects found eligible for study participation will be randomized into one of the4 treatment arms (1:1:1:1) as per randomization schedule for a treatmentperiod of 7 days. The study will be conducted over 9 visits including the entirestudy period and tests for parameters will be performed.
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 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy adults who consume less than 200 mg caffeine per day 2.Employed or performing regular daytime work greater than or equal to 5days per week and greater than or equal to 8hours per day 3.Self-report of feeling tired by the evening on most working days (greater than or equal to 4days per week) confirmed by screening questions and by validated Fatigue Severity Scale (FSS) and ESS.
- •4.Willing and able to attend clinic visits in the assessment window.
- •5.BMI 18.5–30 kg per meter square.
- •6.Willingness to refrain from medications, alcohol or supplements 12 hours prior to testing.
- •7.Ability to provide informed consent and comply with all study requirements.
排除标准
- •1.Pregnant or lactating women 2.Individuals with cardiovascular disease, hypertension, metabolic disorders, current diagnosis of major psychiatric disorder or cognitive disorder, chronic fatigue syndrome or post-viral fatigue diagnosis 3.Individuals with hearing or visual impairment, sleep disorders, or shift workers 4.Individuals with excessive daytime sleepiness 5.Hypersensitivity to study products 6.Chronic caffeine consumers exceeding 400 mg per day 7.Use of medications and supplements that could affect cognitive or physical performance 8.Chronic medical conditions or lifestyle factors that may affect outcomes.
- •9.Participation in another clinical trial within the past 30 days.
- •10.Prior experience or familiarity with the assessment tool.
研究者
Dr Arun Kumar Rawal
Prehab Musculoskeletal and Sports Health Clinics