"WakeUp" for Vigilance Following Lunch

NCT04685005 | Completed

• 1 other identifier: WU 2018 GT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatigue

Outcome Measures

Primary Outcomes (3)

• Alertness assessed at baseline before drinking Wake Up

  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

  time 0 - baseline

• Alertness assessed at 30 minutes after drinking Wake Up

  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

  30 minutes

• Alertness assessed at 120 minutes after drinking Wake Up

  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

  120 minutes

Secondary Outcomes (9)

• Neurocognitive attention test at baseline before drinking Wake Up

  time 0 - baseline

• Neurocognitive attention test at 30 minutes after drinking Wake Up

  30 minutes

• Neurocognitive attention test at 120 minutes after drinking Wake Up

  120 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

Study Arms (5)

Wake up

EXPERIMENTAL

Drinking regular formula of Wake Up

Dietary Supplement: "Wake Up"; Dietary Supplement: Caffeine

Caffeine

ACTIVE COMPARATOR

Drinking 100mg of Caffeine

Dietary Supplement: "Wake Up"; Dietary Supplement: Caffeine

Placebo

PLACEBO COMPARATOR

Drinking Placebo (only water with sugar)

Dietary Supplement: "Wake Up"; Dietary Supplement: Caffeine

Wake up Double Dose

EXPERIMENTAL

Drinking formula of Wake Up with double doses of guarana, green tea, elderberry and Fruit-up

Dietary Supplement: "Wake Up"; Dietary Supplement: Caffeine

Wake up tripple dose

EXPERIMENTAL

Drinking formula of Wake Up with tripple doses of guarana, green tea, elderberry and Fruit-up

Dietary Supplement: "Wake Up"; Dietary Supplement: Caffeine

Interventions

"Wake Up" DIETARY_SUPPLEMENT

The current composition of the WakeUp® beverage consists of herbal extracts of guarana, green tea, elderberry and Fruit-up

Also known as: Caffeine, Placebo

Caffeine; Placebo; Wake up; Wake up Double Dose; Wake up tripple dose

Caffeine DIETARY_SUPPLEMENT

Caffeine

Caffeine; Placebo; Wake up; Wake up Double Dose; Wake up tripple dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmel Medical Center: lead

Study Sites (1)

Carmel Medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Fatigue

Interventions

Wuc protein, Drosophila; Caffeine

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Giora P Pillar, Prof

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Pediatrics and Sleep Clinic

Model Details: Participants will be randomized regarding the order of the various beverages they drink, in a double blind placebo and active control model.

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 28, 2020
• Study Start: November 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)