NCT02084758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2014

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 6, 2017

Status Verified

September 1, 2016

Enrollment Period

1.1 years

First QC Date

February 17, 2014

Last Update Submit

February 3, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDnitrate supplementationmetabolic efficiency

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in blood pressure during exercise

    Baseline, day 7, day 14 and day 21.

  • Change in dyspnea during exercise

    Baseline, day 7, day 14 and day 21.

  • Change in cycle endurance time during exercise.

    Baseline, day 7, day 14 and day 21.

  • Change in oxygen uptake (VO2 mL/min) during exercise

    Baseline, day 7, day 14 and day 21

  • Change in Resting Energy Expenditure (REE)

    Baseline, day 7, day 14 and day 21

  • +1 more secondary outcomes

Other Outcomes (5)

  • VO2max and Wmax

    Baseline

  • height, body weight and body mass index (BMI)

    Baseline

  • Fat free mass and fat mass

    Baseline

  • +2 more other outcomes

Study Arms (2)

Nitrate supplementation

ACTIVE COMPARATOR

Sodium nitrate solution

Dietary Supplement: Nitrate supplementationDietary Supplement: Placebo supplementation

Placebo supplementation

PLACEBO COMPARATOR

Sodium chloride solution

Dietary Supplement: Nitrate supplementationDietary Supplement: Placebo supplementation

Interventions

Nitrate supplementationDIETARY_SUPPLEMENT

7 days of supplementation with sodium nitrate solution

Nitrate supplementationPlacebo supplementation
Placebo supplementationDIETARY_SUPPLEMENT

7 days of supplementation with sodium chloride solution

Nitrate supplementationPlacebo supplementation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD
  • Indication metabolic inefficiency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annemie Schols, Prof.

    Maastricht University Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2014

First Posted

March 12, 2014

Study Start

September 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

February 6, 2017

Record last verified: 2016-09

Locations

NL(1)