Dietary Interventions in Asthma Treatment: Sprouts Study
Słowa kluczowe
Abstrakcyjny
Opis
After eligibility is confirmed, participants will be randomized to (a) placebo then BS or (b) BS then placebo. At randomization, baseline exhaled nitric oxide (eNO), forced expiratory volume at one second (FEV1), nasal epithelial gene expression, urinary OS biomarkers, serum inflammatory and OS biomarkers, and basophil activation will be assessed. These will be assessed again after 7 days on the assigned intervention at two time points: pre- and post-EMAC. The 1 week time period was chosen because previous studies have shown that daily ingestion of a broccoli sprout homogenate for three days resulted in upregulation of phase II enzyme gene expression in nasal epithelial cells. Following a 2-week washout period, this protocol will be repeated for the second intervention, phase II. The 2 week washout period will be sufficient as the half life of the extract of the active ingredient in broccoli sprouts, SFN, has been shown to be 1.8 hours.(16) Participants' diets will be assessed before and after each intervention with a Food Frequency Questionnaire and a questionnaire to capture intake of specific foods that are rich in SFN.
Daktyle
| Ostatnia weryfikacja: | 04/30/2019 |
| Pierwsze przesłane: | 08/16/2010 |
| Szacowana liczba przesłanych rejestracji: | 08/16/2010 |
| Wysłany pierwszy: | 08/17/2010 |
| Ostatnia aktualizacja przesłana: | 05/12/2019 |
| Ostatnia opublikowana aktualizacja: | 06/03/2019 |
| Data pierwszego przesłania wyników: | 04/27/2016 |
| Data pierwszego przesłania wyników kontroli jakości: | 05/12/2019 |
| Data opublikowania pierwszych wyników: | 06/03/2019 |
| Rzeczywista data rozpoczęcia badania: | 10/31/2010 |
| Szacowana data zakończenia podstawowej działalności: | 02/05/2012 |
| Szacowana data zakończenia badania: | 02/05/2012 |
Stan lub choroba
Interwencja / leczenie
Other: Broccoli Sprouts
Other: Alfalfa Sprouts
Faza
Grupy ramion
| Ramię | Interwencja / leczenie |
|---|---|
| Experimental: Broccoli Sprouts, then Alfalfa Sprouts Broccoli Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by alfalfa sprouts after washout. | |
| Experimental: Alfalfa Sprouts, then Broccoli Sprouts Alfalfa Sprout sandwich/wrap will be eaten daily for 7 consecutive days followed by broccoli sprouts after washout. |
Kryteria kwalifikacji
| Wiek kwalifikujący się do nauki | 18 Years Do 18 Years |
| Płeć kwalifikująca się do nauki | All |
| Przyjmuje zdrowych wolontariuszy | tak |
| Kryteria | Inclusion Criteria: - Age 18-49 years - Physician-diagnosed asthma - No other major pulmonary disease such as cystic fibrosis or chronic obstructive pulmonary disease (COPD) - Mouse sensitization, defined by a positive skin prick test to mouse epithelial extract or positive mouse-specific immunoglobulin E (IgE) - Non-smoker Exclusion Criteria: - Severe or unstable asthma defined as requiring hospitalization in the previous year or intubation in the previous 2 years, or on high-dose inhaled corticosteroids or chronic oral corticosteroids - Baseline FEV1 and FEV1/forced vital capacity (FVC) < 70% predicted - Positive skin prick test (SPT) to a pet currently living in the participant's home - Other significant medical issues such as heart disease or poorly controlled hypertension, or hypothyroidism - Pregnancy or nursing/breastfeeding mothers - On beta-blocker therapy - Taking anti-oxidant supplements - Unable to stop antihistamines prior to skin testing - Unable to stop medications that may interfere with allergen challenge responses prior to challenges. - The participant has food allergy to BS or AS. - Omalizumab use within the last 12 months. - Oral corticosteroid use within the last 2 weeks. |
Wynik
Podstawowe miary wyników
1. Change in Forced Expiratory Volume at One Second (FEV1) [30 days]
