Nitrate and Power Output After Two Beetroot Juice Drinks | NCT05452421

Studies
Nitrate and Power Output After Two Beetroot Juice Drinks

NCT05452421

Sponsor

Nanyang Technological University

Status

Completed

Last Update Posted

Apr 9, 2024Actual

Enrollment

28Actual

Phase

Not Applicable

Conditions

Blood Plasma Nitrite

Interventions

Isotonic carbohydrate beetroot juice drink
Beetroot juice drink

Countries

Singapore

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

Apr 2024

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

Jul 1, 2022Actual

Primary Completion Date

Oct 10, 2022Actual

Completion Date

Oct 10, 2022Actual

First Submitted Date

Jul 6, 2022

First Submission Date that Met QC Criteria

Jul 6, 2022

First Posted Date

Jul 11, 2022Actual

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

Apr 7, 2024

Last Update Posted Date

Apr 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephen Burns, Associate Professor, Nanyang Technological UniversityPrincipal Investigator

Lead Sponsor

Nanyang Technological UniversityOTHER

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

The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Optimal timing of drink consumption in relation to exercise can then be prescribed in relation to nitrite appearance in the blood. A randomised controlled trial with participants completing two conditions: (i) BR and (ii) ISO-CB. On each condition participants will consume During each trial, participants will ingest 2 x 285ml of beverage 3 hours prior to performing two jump tests follow by a Wingate test. Salivary NO content will be measured at the start of the morning, 1 hour, 2 hours, 3 hours after consumption of beverage and at the end of the exercise.

Detailed Description

The main aim of this study is to determine and compare the optimal time to achieve peak concentration of blood plasma nitrite after ingestion of beetroot juice (BR) and isotonic beetroot juice (ISO-CB), respectively. Optimal timing of drink consumption in relation to exercise can then be prescribed in relation to nitrite appearance in the blood.
A secondary aim of this study is to evaluate the association between blood plasma nitrite concentration and saliva nitrite concentration after ingestion of the two drinks to determine whether blood plasma analysis can be fully or partially substituted with a salivary nitrite test.
A final aim of this study is to investigate the ergogenic effects of ISO-CB compared with BR during a single 30 second cycling sprint bout (Wingate test) and two jumping tests.

A randomised controlled trial recruiting 24 healthy male and female participants. Each participant will complete two conditions: (i) BR and (ii) ISO-CB. On each condition participants will consume During each trial, participants will ingest 2 x 285ml of beverage 3 hours prior to performing two jump tests follow by a Wingate test. In the next trial, participants will undergo the same procedures, but ingest the beverage that they did not take the previous round. The study will be double-blinded study. Blood samples will be taken before supplementation, 2 hours and 3 hours after consuming the beverage. Salivary NO content will be measured at the start of the morning, 1 hour, 2 hours, 3 hours after consumption of beverage and at the end of the exercise. For each trial, participants will also fill out a sensory evaluation form in relation to the drink consumed. It is hypothesized that blood plasma nitrite and saliva nitrite appearance will be earlier with ISO-CB and that participants will have improved peak and mean power when ISO-CB is consumed compared with BR.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Isotonic carbohydrate beetroot juice drink	Dietary Supplement: Isotonic carbohydrate beetroot juice drink Dietary Supplement: Beetroot juice drink
Group B	Experimental	Beetroot juice drink	Dietary Supplement: Isotonic carbohydrate beetroot juice drink Dietary Supplement: Beetroot juice drink

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isotonic carbohydrate beetroot juice drink	Dietary Supplement	An isotonic carbohydrate beetroot juice drink containing 141 mg nitrate per 100 ml (12.9 mmol). Total of 570 ml serving in two doses of 285 ml over one morning. Contains 6.2 g carbohydrate per 100 ml. Osmolality 304-310 mOsm/kg.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood plasma nitrite	Peak concentration of blood plasma nitrite	3 hours

Secondary Outcomes

Measure	Description	Time Frame
Salivary nitrite	Salivary nitrite concentration	3 hours
Power output	Peak and mean power output	30 seconds

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 21-35 years.
Healthy and injury-free: defined as no positive (Yes) answers to the Physical Activity Readiness Questionnaire (PAR-Q+) and not reporting any other health issues that may be affected by exercise.
Blood pressure: <130/90 mmHg.
Physically active: Engaging in a minimum of 150 minutes of moderate-intensity exercise or 75 minutes of vigorous-intensity physical activity each week determined via self-report Global Physical Activity Questionnaire (GPAQ).
Body mass index (BMI): 18.5-25.0 kg/m2.
Non-smoker.

Exclusion Criteria:

Any allergies to beetroot or isotonic drink.
Asthma.
Any report of personal health issues that may compromise the individual's ability to undertake exercise safely.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen Burns, PhD	Nanyang Technological University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University		Singapore		637616	Singapore

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

Masking Info

Masking

Triple

Masking Description

Two drinks similar in colour and texture have been provided by a local manufacturer which are coded. The code is held with a third party not involved in the research. Participants and researchers will be asked to guess which drink has been used at the end of each trial to confirm the effectiveness of the masking procedure.

Who Masked

ParticipantInvestigatorOutcomes Assessor