Effects of Red Bull® on the Effects of Training and Haemo... | NCT04963556

Studies
Effects of Red Bull® on the Effects of Training and Haemodynamic Parameters

NCT04963556

Sponsor

University of Basel

Status

Completed

Last Update Posted

Jul 15, 2021Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Effects of; Food, Allergic

Interventions

Red Bull

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 18, 2017Actual

Primary Completion Date

Nov 1, 2017Actual

Completion Date

Apr 15, 2018Actual

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Jul 5, 2021

First Posted Date

Jul 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 5, 2021

Last Update Posted Date

Jul 15, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arno Schmidt-Trucksäss, Prof. Dr. med., University of BaselPrincipal Investigator

Lead Sponsor

University of BaselOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background:

Methods:

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Red Bull	Dietary Supplement	Drinking of Red Bull before exercise	Placebo Red Bull

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on blood pressure	Effect on systolic and diastolic blood pressure	24 hours

Secondary Outcomes

Measure	Description	Time Frame
Pulse wave velocity	central pulse wave velocity	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arno Schmidt-Trucksäss, MD	University of Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Basel		Basel		4052	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided