NCT01504646

Brief Summary

The primary aim of this study will be to evaluate the effects of Lyprinol® supplementation on airway inflammation and the bronchoconstrictor response to dry air hyperpnea in individuals with asthma. The investigators hypothesize that Lyprinol® supplementation, compared to placebo, will significantly attenuate airway inflammation and hyperpnea-induced bronchoconstriction in asthmatic individuals.

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 asthma

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable asthma

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, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 23, 2018

Status Verified

April 1, 2013

Enrollment Period

7 months

First QC Date

January 3, 2012

Last Update Submit

October 22, 2018

Conditions

AsthmaExercise-Induced Bronchoconstriction

Keywords

AsthmaExercise-Induced Bronchoconstrictionlipidsn-3 PUFAairway inflammationBronchoconstriction

Outcome Measures

Primary Outcomes (1)

  • Pulmonary Function (Percent Change in FEV1, measured in Liters)

    The percent change in FEV1 is the percent change in the volume of air exhaled during the first second of a forced exhalation as measured before and after the surrogate exercise challenge.

    8 weeks

Secondary Outcomes (1)

  • Fraction of Exhaled Nitric Oxide

    8 weeks

Study Arms (2)

Olive Oil Capsule

PLACEBO COMPARATOR

Ten subjects will take eight placebo olive oil capsules per day for three weeks.

Dietary Supplement: Placebo (Olive Oil)

Lyprinol

EXPERIMENTAL

Ten subjects will take eight Lyprinol capsules per day for three weeks.

Dietary Supplement: Lyprinol

Interventions

LyprinolDIETARY_SUPPLEMENT

8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks

Lyprinol
Placebo (Olive Oil)DIETARY_SUPPLEMENT

8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks

Also known as: Olive Oil
Olive Oil Capsule

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have been diagnosed with asthma and EIB. Evidence of a diagnosis of asthma will include medication use as well as history and symptoms as outlined in the NHLBI Guidelines for the Diagnosis and Management of Asthma. For the diagnosis of EIB, subjects must demonstrate a fall in FEV1 of ≥ 10% after dry air eucapnic voluntary hyperventilation (EVH), a simulated exercise challenge; FEV1 is a measure of lung function
  • Not currently be taking any fish oil supplements
  • Limit their fish consumption to 1 fish meal per week during the course of the study

You may not qualify if:

  • Severe asthma is indicated. These subjects will be identified by a post-EVH drop in FEV1 that is greater than 50% during their first lab testing session or will have a history of severe asthma-related events such as hospitalizations or emergency room visits. Only mild to moderate asthmatics (i.e. subjects whose FEV1 drops by 10-50%) will be included in this study.
  • They taking currently taking asthma maintenance medications
  • They are pregnant
  • They have a history of hyperlipidemia (high cholesterol), hypertension, diabetes, bleeding disorder, delayed clotting time, or seizure disorder
  • They are allergic to shellfish, fish, corn, or soy products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University School of Health, Physical Education, and Recreation

Bloomington, Indiana, 47405, United States

Location

Related Publications (8)

  • Crapo RO, Casaburi R, Coates AL, Enright PL, Hankinson JL, Irvin CG, MacIntyre NR, McKay RT, Wanger JS, Anderson SD, Cockcroft DW, Fish JE, Sterk PJ. Guidelines for methacholine and exercise challenge testing-1999. This official statement of the American Thoracic Society was adopted by the ATS Board of Directors, July 1999. Am J Respir Crit Care Med. 2000 Jan;161(1):309-29. doi: 10.1164/ajrccm.161.1.ats11-99. No abstract available.

    PMID: 10619836BACKGROUND

  • Mickleborough TD. A nutritional approach to managing exercise-induced asthma. Exerc Sport Sci Rev. 2008 Jul;36(3):135-44. doi: 10.1097/JES.0b013e31817be827.

    PMID: 18580294BACKGROUND

  • Dahlen B, Roquet A, Inman MD, Karlsson O, Naya I, Anstren G, O'Byrne PM, Dahlen SE. Influence of zafirlukast and loratadine on exercise-induced bronchoconstriction. J Allergy Clin Immunol. 2002 May;109(5):789-93. doi: 10.1067/mai.2002.123306.

    PMID: 11994701BACKGROUND

  • Horrocks LA, Yeo YK. Health benefits of docosahexaenoic acid (DHA). Pharmacol Res. 1999 Sep;40(3):211-25. doi: 10.1006/phrs.1999.0495.

    PMID: 10479465BACKGROUND

  • Flower RJ, Perretti M. Controlling inflammation: a fat chance? J Exp Med. 2005 Mar 7;201(5):671-4. doi: 10.1084/jem.20050222.

    PMID: 15753201BACKGROUND

  • Soutar A, Seaton A, Brown K. Bronchial reactivity and dietary antioxidants. Thorax. 1997 Feb;52(2):166-70. doi: 10.1136/thx.52.2.166.

    PMID: 9059479BACKGROUND

  • Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest. 2006 Jan;129(1):39-49. doi: 10.1378/chest.129.1.39.

    PMID: 16424411BACKGROUND

  • Mickleborough TD, Murray RL, Ionescu AA, Lindley MR. Fish oil supplementation reduces severity of exercise-induced bronchoconstriction in elite athletes. Am J Respir Crit Care Med. 2003 Nov 15;168(10):1181-9. doi: 10.1164/rccm.200303-373OC. Epub 2003 Aug 6.

    PMID: 12904324BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

lyprinolOlive Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

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

Study Record Dates

First Submitted

January 3, 2012

First Posted

January 5, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 23, 2018

Record last verified: 2013-04

Locations

US(1)