Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effects of Dietary Nitrate Supplementation on Metabolic Efficiency in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084758
• Other study ID #: ABR-47701
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: February 3, 2017
• Start date: September 2015
• Est. completion date: October 2016

Study information

• Verified date: September 2016
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• COPD

• Indication metabolic inefficiency

Exclusion Criteria:

• Sodium intake limitation

• Long-term oxygen therapy

• Severe renal impairment

• Use of medications that may interact with nitrate

• Contra-indications for performing (sub)maximal cycle ergometry

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Dietary Supplement:
• Nitrate supplementation
7 days of supplementation with sodium nitrate solution
• Placebo supplementation
7 days of supplementation with sodium chloride solution

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VO2max and Wmax		Baseline
Other	height, body weight and body mass index (BMI)		Baseline
Other	Fat free mass and fat mass	Fat free mass and fat mass determined by DEXA-scan	Baseline
Other	Lung function		Baseline
Other	Physical activity		During the two supplementation periods
Primary	Change in metabolic efficiency during exercise	Metabolic efficiency (degree of efficiently used energy during exercise) will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21.
Secondary	Change in blood pressure during exercise	Change in blood pressure will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21.
Secondary	Change in dyspnea during exercise	Change in dyspnea will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21.
Secondary	Change in cycle endurance time during exercise.	Change in cycle endurance time will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21.
Secondary	Change in oxygen uptake (VO2 mL/min) during exercise	Change in oxygen uptake will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21
Secondary	Change in Resting Energy Expenditure (REE)	Change in REE will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21
Secondary	Change in plasma concentrations of nitrate and nitrite, glucose, insulin, lactate and free fatty acids, IFABP and cardiac troponin	Change in these plasma concentrations will be assessed during the test days before and after the two supplementation periods (active and placebo) for a total timespan of 3 weeks.	Baseline, day 7, day 14 and day 21