NCT04094233

Brief Summary

Dietary NO3 is found in high concentrations in green leafy vegetables and beets. Studies weighing the action of NO3 for ergogenic purposes have found metabolic improvement in skeletal muscle during exercise in hypoxia, lowering blood pressure and increased workload at anaerobic threshold. In a way, the use of nitrate in combination with exercise may assist in autonomic adaptation to multiple stimuli, such as rest, during exercise and during the recovery period. HRV is one of the most practical methods for analyzing the physiological functioning of the ANS, both in the pathological condition of the individual and in the induction of other variables. peak-R (RRI) of consecutive heart beats. This study aims to evaluate the effect of beet extract supplementation in combination with submaximal strength exercise on heart rate variability and cardiovascular parameters of physically active individuals. It is a double-blind randomized crossover clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable cardiovascular-diseases

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

First Submitted

Initial submission to the registry

September 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

September 15, 2019

Last Update Submit

March 25, 2020

Conditions

Cardiovascular DiseasesPrevention

Keywords

BeetrootHeart rate variabilityBlood pressureStrenght Exercise

Outcome Measures

Primary Outcomes (3)

  • Beetroot extract effects on heart rate variability (based on frequency and time domain)

    up to 1 year

  • Blood pressure (mmHg)

    Beetroot extract effects blood pressure recovery following strength exercise

    up to 1 year

  • Heart rate (beats per minute)

    Beetroot effects heart rate recovery following strength exercise

    up to 1 year

Study Arms (2)

Beetroot Extract

EXPERIMENTAL

Capsule containing 600mg of beetroot extract.

Dietary Supplement: Beetroot extractOther: Placebo

Placebo

EXPERIMENTAL

Capsule containing 600mg of starch.

Dietary Supplement: Beetroot extractOther: Placebo

Interventions

Beetroot extractDIETARY_SUPPLEMENT

Ingestion of 600mg beetroot extract two hours before strength exercise (75% 1RM).

Beetroot ExtractPlacebo
PlaceboOTHER

Ingestion of 600mg starch two hours before strength exercise (75% 1RM).

Beetroot ExtractPlacebo

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)
  • Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more
  • Do not use any medication that may interfere with cardiac autonomic modulation
  • Do have no skeletal muscle damage.

You may not qualify if:

  • Smoking patients
  • As well as individuals who have already used anabolic steroids
  • Cardiorespiratory diseases
  • Neurological disorders
  • Other known compromises that prevent the subject from performing the procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cicero Jonas R Benjamim

Petrolina, Pernambuco, 56328-900, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 18, 2019

Study Start

October 1, 2019

Primary Completion

February 15, 2020

Study Completion

March 23, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Locations

BR(1)