NCT00806442

Brief Summary

The aim of this trial is to determine the efficacy of a combination of two botanicals oils, borage seed oil and echium seed oil, as a potential treatment for bronchial asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2008

Typical duration for phase_1

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

December 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

July 3, 2017

Completed
Last Updated

July 3, 2017

Status Verified

June 1, 2017

Enrollment Period

3.3 years

First QC Date

December 9, 2008

Results QC Date

July 16, 2014

Last Update Submit

June 6, 2017

Conditions

Bronchial Asthma

Keywords

AsthmaFatty acidsLeukotrienesDiet

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in 1 Second (FEV1)

    Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo

    6 weeks

Secondary Outcomes (6)

  • Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes

    6 weeks on each treatment assignment

  • Peak Flow Rate (PEFR)

    6 weeks

  • Frequency of Rescue Use of Short Acting Beta-2 Agonists

    6 weeks

  • Day-time Symptoms of Bronchial Asthma

    6 weeks

  • Night-time Wakenings

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

1: Borage Seed Oil and Echium Seed Oil

EXPERIMENTAL

Borage/Echium plant seed oils: 2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.

Drug: Borage Seed Oil and Echium Seed Oil

2: Placebo Comparator

PLACEBO COMPARATOR

Placebo comparator: 9 g/day corn oil

Dietary Supplement: Corn Oil

Interventions

Borage Seed Oil and Echium Seed OilDRUG

2 g/day of borage seed oil and 7 g/day of echium seed oil to provide 1.6 g/day of GLA and 0.9 g/day of SDA.

Also known as: CROSSENTIAL GLA TG40, INCROMEGA V3
1: Borage Seed Oil and Echium Seed Oil
Corn OilDIETARY_SUPPLEMENT

9 g/day of corn oil

2: Placebo Comparator

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of bronchial asthma
  • Male or female 18 years to 65 years of age
  • FEV1 50 to 90% of predicted, or personal best.
  • Improvement of \>=12% FEV1 with bronchodilator

You may not qualify if:

  • Pregnant or nursing
  • Smoking history of \> 10 pack years or active smoking within the past year.
  • leukotriene modifying drugs,
  • theophylline
  • oral steroids.
  • dietary supplements with fatty acids or other products that may interfere with leukotriene generation.
  • Treatment within the previous three months with omalizumab (monoclonal antibody directed against IgE)
  • Subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the week prior to any measurements of ex vivo leukotriene generation because of their effects on leukotriene biosynthesis via inhibition of prostaglandin generation.
  • A history of aspirin-sensitive asthma
  • Significant abnormalities in CBC, differential white cell count, renal function, and liver function, or urinalysis.
  • Any serious co-morbid medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma Research Center, Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

  • James MJ, Ursin VM, Cleland LG. Metabolism of stearidonic acid in human subjects: comparison with the metabolism of other n-3 fatty acids. Am J Clin Nutr. 2003 May;77(5):1140-5. doi: 10.1093/ajcn/77.5.1140.

    PMID: 12716664BACKGROUND

  • Chilton-Lopez, Surette ME, Swan DD, Fonteh AN, Johnson MM, Chilton FH. Metabolism of gammalinolenic acid in human neutrophils. J Immunol. 1996 Apr 15;156(8):2941-7.

    PMID: 8609415BACKGROUND

  • Johnson MM, Swan DD, Surette ME, Stegner J, Chilton T, Fonteh AN, Chilton FH. Dietary supplementation with gamma-linolenic acid alters fatty acid content and eicosanoid production in healthy humans. J Nutr. 1997 Aug;127(8):1435-44. doi: 10.1093/jn/127.8.1435.

    PMID: 9237935BACKGROUND

  • Barham JB, Edens MB, Fonteh AN, Johnson MM, Easter L, Chilton FH. Addition of eicosapentaenoic acid to gamma-linolenic acid-supplemented diets prevents serum arachidonic acid accumulation in humans. J Nutr. 2000 Aug;130(8):1925-31. doi: 10.1093/jn/130.8.1925.

    PMID: 10917903BACKGROUND

  • Surette ME, Koumenis IL, Edens MB, Tramposch KM, Chilton FH. Inhibition of leukotriene synthesis, pharmacokinetics, and tolerability of a novel dietary fatty acid formulation in healthy adult subjects. Clin Ther. 2003 Mar;25(3):948-71. doi: 10.1016/s0149-2918(03)80116-9.

    PMID: 12852710BACKGROUND

  • Surette ME, Koumenis IL, Edens MB, Tramposch KM, Clayton B, Bowton D, Chilton FH. Inhibition of leukotriene biosynthesis by a novel dietary fatty acid formulation in patients with atopic asthma: a randomized, placebo-controlled, parallel-group, prospective trial. Clin Ther. 2003 Mar;25(3):972-9. doi: 10.1016/s0149-2918(03)80117-0.

    PMID: 12852711BACKGROUND

  • Kazani S, Arm JP, Boyce J, Chhay H, Dutile S, Wechsler ME, Govindarajulu U, Ivester P, Ainsworth HC, Sergeant S, Chilton FH, Israel E. LTC4 synthase polymorphism modifies efficacy of botanical seed oil combination in asthma. Springerplus. 2014 Nov 6;3:661. doi: 10.1186/2193-1801-3-661. eCollection 2014.

    PMID: 25485197DERIVED

Related Links

MeSH Terms

Conditions

Asthma

Interventions

borage oilCorn Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Elliot Israel, MD
Organization
Brigham and Women's Hospital
eisrael@partners.org
617-732-2801

Study Officials

  • Elliot Israel, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2008

First Posted

December 10, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2012

Study Completion

August 1, 2012

Last Updated

July 3, 2017

Results First Posted

July 3, 2017

Record last verified: 2017-06

Locations

US(1)