NCT04963556

Brief Summary

Background: The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved. Methods: A total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2020

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
Last Updated

July 15, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

November 13, 2020

Last Update Submit

July 5, 2021

Conditions

Effects of; Food, Allergic

Outcome Measures

Primary Outcomes (1)

  • Effect on blood pressure

    Effect on systolic and diastolic blood pressure

    24 hours

Secondary Outcomes (1)

  • Pulse wave velocity

    24 hours

Study Arms (2)

Red Bull

EXPERIMENTAL

Drinking of 355 ml Red Bull

Dietary Supplement: Red Bull

Placebo

PLACEBO COMPARATOR

Drinking of 355 ml sweetened water

Dietary Supplement: Red Bull

Interventions

Red BullDIETARY_SUPPLEMENT

Drinking of Red Bull before exercise

Also known as: Placebo
PlaceboRed Bull

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • No known cardiovascular diseases such as arterial hypertension and diabetes mellitus.
  • No ophthalmological diseases such as glaucoma or macular degeneration.
  • No regular medication
  • No vasodilator abuse for 24 h before the respective intervention (e.g. smoking, use of stimulants, β-blockers).
  • No pregnancy (anamnestic)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Basel

Basel, 4052, Switzerland

Location

Study Officials

  • Arno Schmidt-Trucksäss, MD

    University of Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Blinded to verum or placebo drink
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

November 13, 2020

First Posted

July 15, 2021

Study Start

June 18, 2017

Primary Completion

November 1, 2017

Study Completion

April 15, 2018

Last Updated

July 15, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)