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Dose and Response of Dietary Nitrate in Healthy and Active Men

NCT ID: NCT01961427

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-11-30

Brief Summary

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It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement.

It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate.

Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at different time points and the subjects have to perform an exercise test measuring oxygen consumption 3 hours after the ingestion of nitrate.

Detailed Description

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1. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure nitrate and nitrite concentration in the blood.
2. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Three hours after the intake of the supplement the subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50% of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood withdrawal is taken before the ingestion, after 3 hours and after the test.

Conditions

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Healthy

Keywords

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dietary nitrate beetroot juice exercise performance oxygen consumption

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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sodium Nitrate 12mmol

Ingestion of a solution of inorganic nitrate, dosage: 12mmol

Group Type ACTIVE_COMPARATOR

sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate

sodium Nitrate (6mmol)

ingestion of inorganic nitrate (6mmol solution)

Group Type ACTIVE_COMPARATOR

sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate

sodium nitrate 3mmol

ingestion of inorganic nitrate (3mmol solution)

Group Type ACTIVE_COMPARATOR

sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate

sodium nitrate (0mmol)

Ingestion of water as a placebo

Group Type ACTIVE_COMPARATOR

sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate

Beetroot juice (12mmol)

ingestion of 170ml of concentrated beetroot juice (12mmol)

Group Type ACTIVE_COMPARATOR

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)

beetroot juice (6mmol)

ingestion of 85ml concentrated beetroot juice (6mmol)

Group Type ACTIVE_COMPARATOR

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)

Beetroot juice (3mmol)

Ingestion of 42.5ml of concentrated beetroot juice (3mmol)

Group Type ACTIVE_COMPARATOR

Beetroot juice

Intervention Type DIETARY_SUPPLEMENT

concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)

Interventions

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sodium nitrate

Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate

Intervention Type DIETARY_SUPPLEMENT

Beetroot juice

concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Inorganic nitrate Biotta beetroot juice shot

Eligibility Criteria

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Inclusion Criteria

* age 18 to 45
* healthy active men
* non-smoking

Exclusion Criteria

* medication intake during study phase
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudio Perret, Dr. sc. nat.

Role: PRINCIPAL_INVESTIGATOR

Sportmedizin Nottwil

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2013-12

Identifier Type: -

Identifier Source: org_study_id