Dose and Response of Dietary Nitrate in Healthy and Active Men

NCT01961427 | Completed

• 1 other identifier: 2013-12
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

dietary nitrate; beetroot juice; exercise performance; oxygen consumption

Outcome Measures

Primary Outcomes (1)

• oxygen consumption

  Oxygen consumption during exercise protocol

  30min

Secondary Outcomes (5)

• Blood pressure

  6 hours

• oxygen saturation

  6 hours

• Rating of perceived exertion (RPE)

  during the 7 weeks of study phase

• Heart rate

  during the 7 weeks of study phase

• Nitrate and nitrite concentration

  6 hours

Study Arms (7)

sodium Nitrate 12mmol

ACTIVE COMPARATOR

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

Dietary Supplement: sodium nitrate

sodium Nitrate (6mmol)

ACTIVE COMPARATOR

ingestion of inorganic nitrate (6mmol solution)

Dietary Supplement: sodium nitrate

sodium nitrate 3mmol

ACTIVE COMPARATOR

ingestion of inorganic nitrate (3mmol solution)

Dietary Supplement: sodium nitrate

sodium nitrate (0mmol)

ACTIVE COMPARATOR

Ingestion of water as a placebo

Dietary Supplement: sodium nitrate

Beetroot juice (12mmol)

ACTIVE COMPARATOR

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

Dietary Supplement: Beetroot juice

beetroot juice (6mmol)

ACTIVE COMPARATOR

ingestion of 85ml concentrated beetroot juice (6mmol)

Dietary Supplement: Beetroot juice

Beetroot juice (3mmol)

ACTIVE COMPARATOR

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

Dietary Supplement: Beetroot juice

Interventions

sodium nitrate DIETARY_SUPPLEMENT

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

Also known as: Inorganic nitrate

sodium Nitrate (6mmol); sodium Nitrate 12mmol; sodium nitrate (0mmol); sodium nitrate 3mmol

Beetroot juice DIETARY_SUPPLEMENT

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

Also known as: Biotta beetroot juice shot

Beetroot juice (12mmol); Beetroot juice (3mmol); beetroot juice (6mmol)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• medication intake during study phase

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• University of Zurich: collaborator

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Interventions

sodium nitrate

Study Officials

• Claudio Perret, Dr. sc. nat.

  Sportmedizin Nottwil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2013
• First Posted: October 11, 2013
• Study Start: June 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

CH (1)