Double Blind Placebo and Active (Caffeine) Controlled Study to Examine the Effects of 3 Doses of "WakeUp" Herbal Beverage Containing Green Tea (Instead of Ginkgo Biloba) on Vigilance and Function of Healthy Volunteers Following Lunch
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Alertness assessed at 30 minutes after drinking Wake Up
研究概览
简要总结
This is a single center, double-blind, placebo and active controlled clinical trial comprised of a single drink of WakeUp beverage (in 3 doses) compared to Caffeine (100mg) and placebo given to health volunteers.
Participants will be randomized regarding the order of the various beverages. Healthy volunteers or stable (under treatment) patients with chronic diseases) will be included. They will be studied 5 times, in a 2-14 days period, each time during noontime (between 11:30 and 15:00).
Each day of the study, the participants will follow the following schedule:
Lunch any time between 11:30 and 13:30 Time 0: Immediately after lunch a baseline set of assessment. Time 30min: Participants will then consume a beverage (which will be either placebo or 100mg caffeine or single/double/triple dose of WakeUp in the various days) Time 60min: Repeat the same set of assessments as done 30min after beverage Time 150min: Repeat the same set of assessments 2 hours after beverage Time 180min: End of day assessment
详细描述
This is a randomized, double-blind, controlled study with placebo and active control, to test the efficacy and safety of WakeUp on alertness and function in 30 healthy or chronically ill but stable adult volunteers.
Participants and recruitment Thirty volunteers will be recruited via advertisements (in the hospital and university environment). Initial assessment of inclusion and exclusion criteria will take place on the primary visit, and once participants have met the criteria for participation and sign an informed consent, they will enter the study and undergo randomization. It is permitted for participants to have any chronic disease (such as hypertension or diabetes) if they are stable and controlled. Participants will continue taking their own medications (as long as they are not stimulants or sedating, in which case the subject will be excluded).
Study procedure and schedule This is a single center, double-blind, placebo and active controlled clinical trial comprised of a single drink of WakeUp® beverage (in 3 doses) compared to caffeine (100mg) and placebo given to health volunteers. Participants will be randomized regarding the order of the various beverages.
The following visits and schedule will comprise the study:
- Screening visit: In this visit study procedures will be expained, inclusionqexclusion criteria determined, informed consent signed).
- Visit 1: Participants eats their regular lunce following which a first set of studies takes place (see below). Immediately thereafter the participant drinks the tested beverage (marked A, B, C, D, E or F, randomized order regarding which beverage of the 6 is drank at each specific study day, blinded to the participant and the staff). Thirty minutes after drinking a second set of studies will take place (exactly equal to the previous set of studies). A third set of studies (exactly the same as the previous two) will take place 2 hours following the drink.
- Visits 2, 3, 4, and 5 are exactly like visit 1, just that the beverage is one of the others (randomized), such that each participants after completing 5 visits had all tested beverages: placebo, 100mg Caffeine, WakeUp® regular dose, WakeUp® double dose, WakeUp® triple dose.
- Visit 7: A telephone call or a face-to-face visit (based on the preference of the participants) one week after the study to make sure there are no side effects and to close participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding will be kept by the manufacturer of the beverages (Frutarom USA, Inc). All 5 beverages (placebo, 100mg Caffeine, WakeUp® regular dose, WakeUp® double dose, and WakeUp® triple dose) will be marked by a letter beween A to E, which will be blinded to the participants and the staff of the study. Only after the completion of the study (all 30 participants), and statistical analysis and reporting will the various beverages (letters) will be unblinded. The only occasion of unblinding prior to study completion will be the unexpected occasion of a serious side effect.
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers or chronically ill patients in stable condition
- •Adults age 18 and above
- •Volunteers who are willing and able to sign the informed consent
排除标准
- •Children aged less than 18 years.
- •Subjects participating in another study
- •Subjects who are unable to comply with the study procedures.
- •Patients in an unstable medical condition.
- •Patients who are treated with sedating or stimulant medications
- •Subjects who have taken a dietary supplement within one week of the study initiation
- •Subjects who have drunk or eaten any caffeine-containing beverage or food after 7:00 in the morning of any test day
- •Any reason that, in the opinion of the investigator, may make the subject unfit for this clinical trial
研究组 & 干预措施
Caffeine
Drinking 100mg of Caffeine
干预措施: Caffeine (Dietary Supplement)
Wake up tripple dose
Drinking formula of Wake Up with tripple doses of guarana, green tea, elderberry and Fruit-up
干预措施: Caffeine (Dietary Supplement)
Wake up tripple dose
Drinking formula of Wake Up with tripple doses of guarana, green tea, elderberry and Fruit-up
干预措施: "Wake Up" (Dietary Supplement)
Wake up
Drinking regular formula of Wake Up
干预措施: "Wake Up" (Dietary Supplement)
Caffeine
Drinking 100mg of Caffeine
干预措施: "Wake Up" (Dietary Supplement)
Placebo
Drinking Placebo (only water with sugar)
干预措施: "Wake Up" (Dietary Supplement)
Wake up Double Dose
Drinking formula of Wake Up with double doses of guarana, green tea, elderberry and Fruit-up
干预措施: "Wake Up" (Dietary Supplement)
Placebo
Drinking Placebo (only water with sugar)
干预措施: Caffeine (Dietary Supplement)
Wake up Double Dose
Drinking formula of Wake Up with double doses of guarana, green tea, elderberry and Fruit-up
干预措施: Caffeine (Dietary Supplement)
Wake up
Drinking regular formula of Wake Up
干预措施: Caffeine (Dietary Supplement)
结局指标
主要结局
Alertness assessed at 30 minutes after drinking Wake Up
时间窗: 30 minutes
measured by neurocognitive functional test assessed by reaction time response for five-choice variants - a test by Cambridge Cognition company, performed on an iPad tablet
Alertness assessed at baseline before drinking Wake Up
时间窗: time 0 - baseline
measured by neurocognitive functional test assessed by reaction time response for five-choice variants - a test by Cambridge Cognition company, performed on an iPad tablet
Alertness assessed at 120 minutes after drinking Wake Up
时间窗: 120 minutes
measured by neurocognitive functional test assessed by reaction time response for five-choice variants - a test by Cambridge Cognition company, performed on an iPad tablet
次要结局
- Neurocognitive attention test at 30 minutes after drinking Wake Up(30 minutes)
- Neurocognitive executive function test at baseline before drinking Wake Up(time 0 - baseline)
- Neurocognitive executive function test at 30 minutes after drinking Wake Up(30 minutes)
- Neurocognitive attention test at baseline before drinking Wake Up(time 0 - baseline)
- Neurocognitive memory test at 120 minutes after drinking Wake Up(120 minutes)
- Neurocognitive attention test at 120 minutes after drinking Wake Up(120 minutes)
- Neurocognitive memory test at baseline before drinking Wake Up(time 0 - baseline)
- Neurocognitive memory test at 30 minutes after drinking Wake Up(30 minutes)
- Neurocognitive executive function test at 120 minutes after drinking Wake Up(120 minutes)
研究者
Giora Pillar, MD, PhD
Head of Department of Pediatrics and Sleep Clinic
Carmel Medical Center
