NCT03020862

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

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

Study Start

First participant enrolled

December 1, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

January 16, 2017

Status Verified

June 1, 2014

Enrollment Period

4 months

First QC Date

January 11, 2017

Last Update Submit

January 13, 2017

Conditions

Chronic Obstructive Pulmonary Disease Moderate

Keywords

Dietary nitratePhysical performanceBlood pressureNitriteExercise

Outcome Measures

Primary Outcomes (1)

  • Physical performance on 6-min walk test (6MWT)

    6 minutes

Secondary Outcomes (4)

  • 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

Study Arms (2)

Placebo ---> Dietary beetroot

EXPERIMENTAL

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

Dietary beetroot juice --> Placebo

EXPERIMENTAL

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

Interventions

Dietary beetroot juiceDIETARY_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 --> PlaceboPlacebo ---> Dietary beetroot

Eligibility Criteria

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

You may qualify if:

  • Moderate-severe Chronics Obstructive Pulmonary Disease (COPD) (FEV1 \<80% of predicted).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Science, Department of Public Health, Aarhus University

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Mette Hansen

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

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 13, 2017

Study Start

December 1, 2013

Primary Completion

April 1, 2014

Study Completion

August 1, 2015

Last Updated

January 16, 2017

Record last verified: 2014-06

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)