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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease Moderate
• Intervention / Treatment: Dietary supplement: Dietary beetroot juice

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Sport Science, Department of Public Health, Aarhus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Placebo ---> Dietary beetroot; 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.	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.
Experimental: Dietary beetroot juice --> Placebo; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical performance on 6-min walk test (6MWT)	6 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure		At baseline and 150 minutes after consumption of beverages
Plasma Nitrite concentration		Baseline, 150 and 210 minutes after consumption of beverages
Oxygen consumption during submaximal cycling		Two trials of 6 minutes duration (10 min break between trials)
Physical activity level	Measured all intervention days except on the day of testing	Six days

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Mette Hansen, Aarhus University, Department for Public Health, Section for Sport Sciene

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: January 11, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; Blood pressure; Physical performance; Dietary nitrate; Nitrite
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: D2013A2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO