MedTrace Logo

"WakeUp" for Vigilance Following Lunch

NCT04685005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-08

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

"Wake Up"

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

DIETARY_SUPPLEMENT

Caffeine

Caffeine

Sponsors & Collaborators

  • Carmel Medical Center

    lead OTHER

Principal Investigators

  • Giora P Pillar, Prof · Carmel Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04685005 on ClinicalTrials.gov