NCT06073275

Brief Summary

This study was a randomized, double-blind, crossover design for 3 weeks. In the first week, a researcher explained all the experimental procedures to the participants. In the following two weeks, the participants attended the Exercise Physiology laboratory to be assessed in 2 rowing ergometer sessions, separated from each other by a washout period of 7 days, under the same environmental conditions. In both strictly identical sessions, the participants randomly ingested beetroot juice (BRJ) or placebo (PL) 3 hours before the start of the tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2019

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 25, 2023

Last Update Submit

October 7, 2023

Conditions

Keywords

Cardiorespiratory performanceTime trial performanceBeetroot juiceMaster rowerswell-trained

Outcome Measures

Primary Outcomes (7)

  • Rowing performance: Time trial

    minutes:seconds (mm:ss)

    through study completion, an average of 3 weeks

  • Rowing performance: Mean Power output

    Watts

    through study completion, an average of 3 weeks

  • Rowing performance: meter per stroke

    Meters

    through study completion, an average of 3 weeks

  • Cardiorespiratory performance: absolute oxygen uptake

    V̇O2max (L/min)

    through study completion, an average of 3 weeks

  • Cardiorespiratory performance: relative oxygen uptake

    V̇O2max (mL/kg/min)

    through study completion, an average of 3 weeks

  • Cardiorespiratory performance: ventilatory efficiency

    slope of Ventilation/Carbon dioxide production

    through study completion, an average of 3 weeks

  • Metabolic performance: lactate

    mmol/L

    through study completion, an average of 3 weeks

Secondary Outcomes (6)

  • Cardiorespiratory performance: Maximum heart rate

    through study completion, an average of 3 weeks

  • Cardiorespiratory performance: Mean heart rate

    through study completion, an average of 3 weeks

  • Saturation

    through study completion, an average of 3 weeks

  • Cardiorespiratory performance: minute ventilation

    through study completion, an average of 3 weeks

  • Scale of Perceived exertion ratio (RPE)

    through study completion, an average of 3 weeks

  • +1 more secondary outcomes

Study Arms (2)

Beetroot juice intake

EXPERIMENTAL

Beetroot juice was administered 3 h before the start of the rowing ergometer test since the peak of nitrite in the blood occurs 2-3 h after nitrate ingestion. Beetroot juice was provided in a 140 mL maroon plastic bottle with no label. Participants were provided with a randomized bottle containing 140 mL (\~12.8 mmol, \~808 mg of nitrate) of BRJ Beet-It-Pro Elite Shot concentrate (Beet IT; James White Drinks Ltd., Ipswich, UK).

Dietary Supplement: Beetroot juice ingestion

Placebo intake

PLACEBO COMPARATOR

Placebo was administered 3 h before the start of the rowing ergometer test. Placebo was provided in a 140 mL maroon plastic bottle with no label. Participants were provided with a randomized bottle containing 140 mL. The placebo drink was made by dissolving in 1 liter of water 2g of powdered SUPER BEETROOT (\~ 0.01 mmol, 0.620 mg of nitrate, diet, food, Poland), 100% natural beetroot juice and organic label, and adding lemon juice to imitate the flavor and texture of the beetroot juice drink

Dietary Supplement: Placebo ingestion

Interventions

Beetroot juice ingestionDIETARY_SUPPLEMENT

Beetroot juice ingestion was randomly administered 3 h before the start of the test to the participants in two assessment sessions with a one-week washout between both sessions.

Beetroot juice intake
Placebo ingestionDIETARY_SUPPLEMENT

Placebo ingestion was randomly administered 3 h before the start of the test to the participants in two assessment sessions with a one-week washout between both sessions.

Placebo intake

Eligibility Criteria

Age30 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility Detailswell-trained male master rowers
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • national and/or international level;
  • without cardiovascular, respiratory, metabolic, neurological or orthopedic disorders that may affect the performance of the rowing ergometer test;
  • no consumption of drugs or medicines;
  • no smoking;
  • Informed consent to participate in the study signed by all rowers

You may not qualify if:

  • Ingestion of nutritional supplements taken in the three months prior to the start of the study;
  • no following the guidelines established by the nutrition professional.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Docent Sant Joan de Déu. Universitat de Barcelona

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Study Officials

  • Manuel V Garnacho-Castaño, PhD

    Campus docent Sant Joan de Déu-Universitat de Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: This study was a randomized, double-blind, crossover design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 10, 2023

Study Start

November 1, 2018

Primary Completion

January 31, 2019

Study Completion

February 26, 2019

Last Updated

October 10, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations