Flaxseed Modulates Inflammation and Oxidative Stress in CF

Cystic Fibrosis Clinical Trial

Official title:

Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014181
• Other study ID #: 815533
• Status: Completed
• Phase: Phase 1
• First received: November 27, 2013
• Last updated: January 6, 2014
• Start date: July 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Inflammation
• Oxidative Stress

Intervention

Dietary Supplement:
• finely ground flaxseed powder
40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (1)

J. B. Turowski, M. Christofidou-Solomidou, J. A. Lawson, D. Hadjiliadis, Am J Respir Crit Care Med 187;2013:A2069 Modulation Of Inflammatory And Oxidative Stress Biomarkers In Cystic Fibrosis Patients By A Dietary Botanical A94 THERAPEUTIC AND DIAGNOSTIC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with side effects secondary to flaxseed ingestion	10 patients with cystic fibrosis were asked to consume 40 grams daily of finely ground flaxseed powder (however they wished) for one month. To assess side effects, each patient kept a journal to ascertain what side effects (if any) were most common among consumers of this dose of flaxseed. Side effects could include, but were not limited to, nausea, bloating, diarrhea or constipation. Other even rarer side effects could be bleeding, flushing, or anaphylaxis.	one month	Yes
Secondary	Measure levels of flaxseed metabolism in the blood of patients with cystic fibrosis	10 patients with cystic fibrosis consumed 40 grams of flaxseed daily. One time per week (four times total), blood was drawn to assess systemic levels of flaxseed metabolites.	one month	No
Secondary	Measure biomarkers of systemic oxidative stress	10 patients with CF who had consumed 40 grams daily of flaxseed had urine and blood collected once weekly to ascertain potential effects of flaxseed consumption on systemic biomarkers of oxidative stress, including F2-isoprostanes, 8-oxo-dGuo, TNFa, IL-6, IFNg.	one month	No