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Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients (COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease Moderate

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Dietary beetroot juice
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease Moderate focused on measuring Dietary nitrate, Physical performance, Blood pressure, Nitrite, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sport Science, Department of Public Health, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Placebo ---> Dietary beetroot

Dietary beetroot juice --> Placebo

Arm Description

Placebo was administrated in the first period of the cross-over trial, while the intervention beverage Dietary Beetroot juice was administrated in the second period of the trial. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days. Intervention beverage, Dietary beetroot juice:Consumed as 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.

The intervention beverage Dietary beetroot juice was administrated in the first period of the cross-over trial, while placebo was administrated in the second period of the trail Intervention beverage, Dietary beetroot juice:Consumed as 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. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.

Outcomes

Primary Outcome Measures

Physical performance on 6-min walk test (6MWT)

Secondary Outcome Measures

Blood Pressure
Plasma Nitrite concentration
Oxygen consumption during submaximal cycling
Physical activity level
Measured all intervention days except on the day of testing

Full Information

First Posted
January 11, 2017
Last Updated
January 13, 2017
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT03020862
Brief Title
Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
Acronym
COPD
Official Title
Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease Moderate
Keywords
Dietary nitrate, Physical performance, Blood pressure, Nitrite, Exercise

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo ---> Dietary beetroot
Arm Type
Experimental
Arm Description
Placebo was administrated in the first period of the cross-over trial, while the intervention beverage Dietary Beetroot juice was administrated in the second period of the trial. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days. Intervention beverage, Dietary beetroot juice:Consumed as 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.
Arm Title
Dietary beetroot juice --> Placebo
Arm Type
Experimental
Arm Description
The intervention beverage Dietary beetroot juice was administrated in the first period of the cross-over trial, while placebo was administrated in the second period of the trail Intervention beverage, Dietary beetroot juice:Consumed as 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. The placebo: was an NO3- negligble drink from James White Drinks England (Beet-it), which was otherwise similar to the dietary beetroot juice in nutrient composition, smell and appearance. Dose: 2x70 mL consumed twice a day for six days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary beetroot juice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical performance on 6-min walk test (6MWT)
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Blood Pressure
Time Frame
At baseline and 150 minutes after consumption of beverages
Title
Plasma Nitrite concentration
Time Frame
Baseline, 150 and 210 minutes after consumption of beverages
Title
Oxygen consumption during submaximal cycling
Time Frame
Two trials of 6 minutes duration (10 min break between trials)
Title
Physical activity level
Description
Measured all intervention days except on the day of testing
Time Frame
Six days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Hansen
Organizational Affiliation
Aarhus University, Department for Public Health, Section for Sport Sciene
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sport Science, Department of Public Health, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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Beetroot Juice - Effects on Performance in Chronic Obstructive Pulmonary Disease Patients

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