Flaxseed Modulates Inflammation and Oxidative Stress in CF

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02014181
• Date of registration: 27/11/2013
• Prospective Registration: No
• Primary sponsor: University of Pennsylvania
• Public title: Flaxseed Modulates Inflammation and Oxidative Stress in CF
• Scientific title: Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls
• Date of first enrolment: July 2012
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02014181
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Melpo Christofidou-Solomidou, Ph.D.
• Affiliation: University of Pennsylvania

• Name: Jason B Turowski, MD
• Affiliation: University of Pennsylvania

• Name: Denis Hadjiliadis, MD
• Affiliation: University of Pennsylvania

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Oxidative Stress

Cystic Fibrosis

Inflammation

Intervention(s)

Dietary Supplement: finely ground flaxseed powder

Primary Outcome(s)

Number of patients with side effects secondary to flaxseed ingestion [Time Frame: one month]

Secondary Outcome(s)

Measure levels of flaxseed metabolism in the blood of patients with cystic fibrosis [Time Frame: one month]

Measure biomarkers of systemic oxidative stress [Time Frame: one month]

Secondary ID(s)

815533

Source(s) of Monetary Support

Please refer to primary and secondary sponsors