Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT03020862 |
Date of registration:
|
11/01/2017 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
COPD |
Scientific title:
|
Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients |
Date of first enrolment:
|
December 2013 |
Target sample size:
|
15 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT03020862 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Denmark
| | | | | | | |
Contacts
|
Name:
|
Mette Hansen |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
Aarhus University, Department for Public Health, Section for Sport Sciene |
| | |
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Chronic Obstructive Pulmonary Disease Moderate
|
Intervention(s)
|
Dietary Supplement: Dietary beetroot juice
|
Primary Outcome(s)
|
Physical performance on 6-min walk test (6MWT)
[Time Frame: 6 minutes]
|
Secondary Outcome(s)
|
Blood Pressure
[Time Frame: At baseline and 150 minutes after consumption of beverages]
|
Oxygen consumption during submaximal cycling
[Time Frame: Two trials of 6 minutes duration (10 min break between trials)]
|
Physical activity level
[Time Frame: Six days]
|
Plasma Nitrite concentration
[Time Frame: Baseline, 150 and 210 minutes after consumption of beverages]
|
Secondary ID(s)
|
D2013A2014
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|