Flaxseed Modulates Inflammation and Oxidative Stress in CF

Completed · Phase 1

Conditions studied: Cystic Fibrosis, Oxidative Stress, Inflammation

In brief

Flaxseed (FS) is a safe and well tolerated supplement with an ability to fight inflammation and oxidative stress - a byproduct of daily stress the human body faces everyday and especially with chronic diseases. Cystic fibrosis (CF) is a genetic disease resulting from a mutation in sodium and chloride transport channels that results in pancreatic insufficiency, chronic sinusitis and chronic lung infections. The investigators hypothesize that chronic inflammation and oxidative stress are a part of the chronic exacerbations that are a part of cystic fibrosis. The investigators believe that flaxseed with its anti-inflammatory and antioxidative properties can help dampen these stressors on the CF lung and potentially result in fewer exacerbations of CF, fewer antibiotics, fewer hospitalizations, and improved well-being.

Key facts

Study ID

NCT02014181

Run by

University of Pennsylvania

People needed

10

Starts

2012-07-01

Expected to finish

2013-01-01

Last updated by the study team

2014-01-07

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Genetic and clinical diagnosis of cystic fibrosis (CF)
• FEV1 predicted between 40-100%
• Age 18-64
• Pancreatic enzyme adherence (or pancreatic sufficiency)
• Demonstration of continued long-term dedication and follow-up with CF primary care provider

You may not qualify if…

• Prior or planned hospitalization or surgical procedure within one month of enrollment (other than simple dental procedure)
• An acute pulmonary exacerbation
• History of bowel resection, inflammatory bowel disease or distal intestinal obstruction syndrome
• Receiving broad spectrum intravenous antibiotics (other than maintenance azithromycin, inhaled tobramycin, or inhaled aztreonam within one month of enrollment)
• Current supplementation with FS or soy derivatives or allergies to them
• Active or prior ingestion of Vitamin E exceeding 30 IU within 21 days
• Significant liver disease (cirrhosis)
• Significant renal dysfunction (GFR below 50 ml/hr/m2)
• Poorly controlled diabetes (evidenced by HgbA1c>7.5% or consistently with blood glucose >250 mg/dl)

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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