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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT03020862

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease Moderate	Dietary Supplement: Dietary beetroot juice	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Physical performance on 6-min walk test (6MWT) [6 minutes]

Secondary Outcome Measures

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 [Six days]
Measured all intervention days except on the day of testing