NCT05841407

Brief Summary

Ingested beetroot contains inorganic nitrate which is later converted to nitric oxide (NO) in the bloodstream. NO is an important signaling molecule with several physiological functions in the body including acting as a vasodilator, expanding arteries and improving blood flow. Beetroot juice contain inorganic nitrate and consumption of beetroot has been shown to improve skeletal muscle contractility and metabolism enhancing high-intensity exercise performance. Isotonic sports drinks contain carbohydrates and sodium, which also improve exercise performance by providing exogenous glucose for energy to the working muscle and central nervous system and enabling faster absorption of fluid into the bloodstream. The ingestion of exogenous nitrate and isotonic-carbohydrate drink are recognized strategies for promoting exercise performance but whether they can be effectively combined has not been shown. This study will compare the salivary nitrite response, muscle oxygenation and time-trial performance after ingestion of two isotonic drinks with high in nitrate or with no nitrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2024

Completed
Last Updated

April 9, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 11, 2023

Last Update Submit

April 7, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 10 km cycling time trial (endurance) performance

    Time trial

    1 hour after drink ingestion the time taken to complete 10 km on a stationary cycle ergometer will be assessed. Time to complete this is the primary outcome measure .

Secondary Outcomes (2)

  • Salivary nitrate

    Four samples over 2 hours

  • Near infra-red spectroscopy (NIRS)

    During cycling ~1 hour

Study Arms (2)

High nitrate

EXPERIMENTAL

High nitrate isotonic drink

Dietary Supplement: High nitrate isotonic drink

No nitrate

ACTIVE COMPARATOR

No nitrate isotonic drink

Dietary Supplement: No nitrate isotonic drink

Interventions

High nitrate isotonic drinkDIETARY_SUPPLEMENT

High nitrate (12.9 mmol) drink with carbohydrate and minerals

High nitrate
No nitrate isotonic drinkDIETARY_SUPPLEMENT

Carbohydrate and mineral isotonic drink

No nitrate

Eligibility Criteria

Age21 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 21 - 40 years
  • Healthy and injury-free (e.g., no cardiovascular disease, diabetes mellitus, orthopaedic impairment that interferes with moderate-to-vigorous 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.
  • Recreational cyclist (Minimum 1 hour cycling per week)
  • Body mass index: 18.5-25 kg/m2
  • Non-smoker
  • Asian ethnicity by self identification

You may not qualify if:

  • 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.
  • Any recent Covid vaccination (within last 2 weeks).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Bioenergetics Laboratory, National Institute of Education, Nanyang Technological University

Singapore, 637616, Singapore

Location

Study Officials

  • Stephen Burns, PhD

    Nanyang Technological University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Both isotonic drinks (high nitrate or no nitrate) are deidentified and labelled (coded) by a third party not involved with the research. Randomisation is completed by a third party not involved in the testing.
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 3, 2023

Study Start

March 15, 2023

Primary Completion

March 14, 2024

Study Completion

March 14, 2024

Last Updated

April 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

All published data will be placed into the Data Repository of Nanyang Technological University National Institute of Education for public access upon publication.

Shared Documents
ANALYTIC CODE
Time Frame
Upon publication - permanent repository
Access Criteria
Public repository - exact web address available upon publication.
More information

Locations