NCT02355964

Brief Summary

This project aims to study the effects of lifestyle changes on asthma and systemic inflammation in a randomized clinical trial of diet and exercise. The project is a multidisciplinary collaboration in the areas of medicine, physiology and nutrition, centred on improving asthma control in non-obese sedentary asthmatics via simple means.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
149

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Jan 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 28, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

January 16, 2015

Last Update Submit

July 27, 2016

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Questionnaire (Juniper) (ACQ).

    Within 10 days (+/- 1 day) of completing the intervention

Secondary Outcomes (5)

  • Airway hyperresponsiveness to mannitol, as measured by an airway provocation test.

    Within 10 days (+/- 1 day) of completing the intervention

  • Systemic low-grade inflammation, as measured by serum-levels (in microgram/ml) of high sensitivity C-reactive protein, interleukin 6 (IL-6), IL-8, tumor necrosis factor alpha (TNF-alpha) and leptin.

    Within 10 days (+/- 1 day) of completing the intervention

  • Fractional exhaled nitric oxide (FeNO)

    Within 10 days (+/- 1 day) of completing the intervention

  • Sputum inflammatory cell count

    Within 10 days (+/- 1 day) of completing the intervention

  • Adipose tissue inflammatory properties as measured by levels of messenger ribonucleic acid (mRNA) of IL-6, IL-8, leptin and TNF-alpha in abdominal fat biopsies.

    Within 10 days (+/- 1 day) of completing the intervention

Study Arms (4)

exercise

EXPERIMENTAL

exercise (Aerobe training) 3 times per week

Behavioral: Exercise

Diet

EXPERIMENTAL

A diet with an overall high protein content and a low glycemic index

Behavioral: Diet

Diet+Exercise

EXPERIMENTAL

A diet with an overall high protein content and a low glycemic index combined with exercise (Aerobe training) 3 times per week.

Behavioral: ExerciseBehavioral: Diet

control

NO INTERVENTION

Regular lifestyle (no intervention)

Interventions

ExerciseBEHAVIORAL

Aerobe exercise 3 times a week in 8 weeks

Diet+Exerciseexercise
DietBEHAVIORAL

Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks

DietDiet+Exercise

Eligibility Criteria

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

You may qualify if:

  • \>18 years old
  • Uncontrolled or partly uncontrolled asthma
  • Capable of exercising on bike
  • Sedentary (currently do less than 60 min of structured/planned physical activity per week)

You may not qualify if:

  • BMI ≥ 30.0 or \<20.5
  • Chronic obstructive pulmonary disease (COPD), pregnancy, other inflammatory or metabolic diseases
  • The use of oral anti-inflammatory medication or the use of antibiotic treatment during the last 8 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Research Unit, Birpebjerg Hospital

Copenhagen NV, 2400, Denmark

Location

MeSH Terms

Conditions

Asthma

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Vibeke Backer, Professor

    Respiratory Research Unit, Bispebjerg hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 16, 2015

First Posted

February 4, 2015

Study Start

January 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 28, 2016

Record last verified: 2016-07

Locations

DK(1)