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

NCT ID: NCT03020862

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Chronic Obstructive Pulmonary Disease Moderate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Dietary beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

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.

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.

Group Type: EXPERIMENTAL

Dietary beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mette Hansen

Role: PRINCIPAL_INVESTIGATOR

Aarhus University, Department for Public Health, Section for Sport Sciene

Locations

Sport Science, Department of Public Health, Aarhus University

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

D2013A2014

Identifier Type: -

Identifier Source: org_study_id