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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03020862
Other study ID # D2013A2014
Secondary ID
Status Completed
Phase N/A
First received January 11, 2017
Last updated January 13, 2017
Start date December 2013
Est. completion date August 2015

Study information

Verified date June 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) after supplementing with higher doses of dietary NO3-, compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.


Description:

The purpose is to evaluate exercise performance in patients with Chronic Obstructive Pulmonary Disease (COPD) using the 6-minute walk test (6MWT) after supplementing with higher doses of dietary NO3- compared to previous studies, as beetroot juice for seven days. The secondary purpose is to evaluate oxygen consumption of submaximal cycling, amendments in blood pressure, and physical activity level.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date August 2015
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 <80% of predicted).

Exclusion Criteria:

- Smoking,

- failure to complete physical testing,

- on-going participation in rehabilitation programs,

- pacemaker or use of nicotine products,

- oxygen mask,

- beta blockers,

- antibacterial mouthwash,

- chewing gum or stomach-neutralizing medicine during the intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary beetroot juice
Consumed as concentrated beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.

Locations

Country Name City State
Denmark Sport Science, Department of Public Health, Aarhus University Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical performance on 6-min walk test (6MWT) 6 minutes
Secondary Blood Pressure At baseline and 150 minutes after consumption of beverages
Secondary Plasma Nitrite concentration Baseline, 150 and 210 minutes after consumption of beverages
Secondary Oxygen consumption during submaximal cycling Two trials of 6 minutes duration (10 min break between trials)
Secondary Physical activity level Measured all intervention days except on the day of testing Six days
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