Treatment of Bronchial Asthma With Borage and Echium Seed Oils
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Leukotrienes are important in the pathogenesis of inflammation, and leukotriene modifying drugs are now an established treatment for bronchial asthma and rhinitis. Drugs that inhibit the biosynthesis of leukotrienes are likely to be more effective than the currently available drugs that antagonize a single leukotriene receptor. Dietary supplementation with gamma linolenic acid (GLA) in borage seed oil provides effective inhibition of leukotriene generation but also increases circulating free arachidonic acid (AA), which has pro-inflammatory potential. The n-3 fatty acid, eicosapentaenoic acid (EPA), prevented the conversion of GLA to AA. However, EPA is extracted from fish oil, is not well-tolerated due to its taste, and at higher doses appeared to blunt the inhibition of leukotriene biosynthesis by GLA. Stearidonic acid (SDA) is a precursor of EPA that is extracted from Echium plantagineum; it is converted to EPA in humans and it does not have the organoleptic properties of EPA.
We recently completed a dose-ranging study in which we determined the dose of SDA that is sufficient to inhibit the rise in circulating levels of arachidonic acid while maintaining effective inhibition of leukotriene generation.
The goal of the present study is to test the efficacy of dietary supplementation with GLA and SDA (provided in borage seed oil and echium seed oil) in treating bronchial asthma.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Asthma Research Center, Brigham and Women's Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- Pregnant or nursing
- Smoking history of > 10 pack years or active smoking within the past year.
Due to possible effects on leukotriene biosynthesis, use of the following asthma treatments within the preceding month will be exclusion criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 1: Borage Seed Oil and Echium Seed Oil
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.
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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.
Otros nombres:
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Comparador de placebos: 2: Placebo Comparator
Placebo comparator: 9 g/day corn oil
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9 g/day of corn oil
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Forced Expiratory Volume in 1 Second (FEV1)
Periodo de tiempo: 6 weeks
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Forced expiratory volume in 1 second (FEV1) in plant seed oil vs. placebo
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6 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Positive FEV1 Percent Predicted Change Among C Allele Carriers and A Homozygotes
Periodo de tiempo: 6 weeks on each treatment assignment
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Number of participants with positive change in FEV1 % predicted (>0%) among C allele carriers and A homozygotes in each arm
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6 weeks on each treatment assignment
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Peak Flow Rate (PEFR)
Periodo de tiempo: 6 weeks
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Morning Peak Flow Rate in plant seed oil vs. placebo
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6 weeks
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Frequency of Rescue Use of Short Acting Beta-2 Agonists
Periodo de tiempo: 6 weeks
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Average number of puffs of albuterol daily in plant seed oil vs. placebo
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6 weeks
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Day-time Symptoms of Bronchial Asthma
Periodo de tiempo: 6 weeks
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Day-time symptom scores in plant seed oil vs. placebo. 0 = Absent: No symptoms
These numbers were used for 1. Shortness of breath 2. Chest tightness 3. Wheezing 4. Cough 5. Phlegm/Mucus. The total score is the sum of the 5 item scores, for a range of 0-15. A higher score represents more severe symptoms. Each participant's score is the average of varying numbers of diary cards. The treatment phase visits at 6 weeks consisted of 3 weeks of diary cards with a +/- 5 day window. The baseline visits had 2 weeks of diary cards with a +/- 5 day window. The treatment phase measures are adjusted for the baseline measures. |
6 weeks
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Night-time Wakenings
Periodo de tiempo: 6 weeks
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Average number of night-time wakenings in plant seed oil vs. placebo
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6 weeks
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Urinary Leukotriene Levels
Periodo de tiempo: 6 weeks
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Urinary leukotriene levels in plant seed oil vs. placebo
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6 weeks
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2008p001696
- P50AT002782 (Subvención/contrato del NIH de EE. UU.)
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