Flaxseed Modulates Inflammation and Oxidative Stress in CF
מילות מפתח
תַקצִיר
תיאור
Ten patients with steady-state cystic fibrosis (CF) - not hospitalized, not on intravenous antibiotics, with stable FEV1 40-100% predicted were enrolled in a four week long pilot study where-in each patient consumed 40 grams of flaxseed each day, in the form of finely ground flaxseed, however they wished. Prior to starting flaxseed, each week, and then four weeks after each patient had finished taking flaxseed, markers of inflammation and oxidative stress, as well as measurements of flaxseed metabolism were collected. F2-isoprostanes, 8-oxo-dGuo, as well as cytokines including IL-6, TNF-a, IFN-g among others were measured to trend flaxseed effects. Enterolignans - enterodiol and enterolactone (products of flaxseed metabolism) were measured each week as well.
תאריכים
| אומת לאחרונה: | 03/31/2012 |
| הוגש לראשונה: | 11/26/2013 |
| ההרשמה המשוערת הוגשה: | 12/10/2013 |
| פורסם לראשונה: | 12/17/2013 |
| העדכון האחרון הוגש: | 01/05/2014 |
| עדכון אחרון פורסם: | 01/06/2014 |
| תאריך תחילת לימוד בפועל: | 06/30/2012 |
| תאריך סיום משוער משוער: | 11/30/2012 |
| תאריך סיום משוער ללימודים: | 12/31/2012 |
מצב או מחלה
התערבות / טיפול
Dietary Supplement: Flaxseed
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Experimental: Flaxseed 40 grams finely ground flaxseed powder daily for one month in patient with cystic fibrosis | Dietary Supplement: Flaxseed 40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 18 Years ל 18 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | Inclusion Criteria: 1. Genetic and clinical diagnosis of cystic fibrosis (CF) 2. FEV1 predicted between 40-100% 3. Age 18-64 4. Pancreatic enzyme adherence (or pancreatic sufficiency) 5. Demonstration of continued long-term dedication and follow-up with CF primary care provider Exclusion Criteria: 1. Prior or planned hospitalization or surgical procedure within one month of enrollment (other than simple dental procedure) 2. An acute pulmonary exacerbation 3. History of bowel resection, inflammatory bowel disease or distal intestinal obstruction syndrome 4. Receiving broad spectrum intravenous antibiotics (other than maintenance azithromycin, inhaled tobramycin, or inhaled aztreonam within one month of enrollment) 5. Current supplementation with FS or soy derivatives or allergies to them 6. Active or prior ingestion of Vitamin E exceeding 30 IU within 21 days 7. Significant liver disease (cirrhosis) 8. Significant renal dysfunction (GFR below 50 ml/hr/m2) 9. Poorly controlled diabetes (evidenced by HgbA1c>7.5% or consistently with blood glucose >250 mg/dl) |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Number of patients with side effects secondary to flaxseed ingestion [one month]
אמצעי תוצאה משניים
1. Measure levels of flaxseed metabolism in the blood of patients with cystic fibrosis [one month]
2. Measure biomarkers of systemic oxidative stress [one month]
