Flaxseed Modulates Inflammation and Oxidative Stress in CF

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Cystic Fibrosis; Oxidative Stress
• Intervention / Treatment: Dietary supplement: finely ground flaxseed powder

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flaxseed; 40 grams finely ground flaxseed powder daily for one month in patient with cystic fibrosis	Dietary supplement: finely ground flaxseed powder; 40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis; Other Names: Linseed oil; SDG; flaxseed; Flax; Bene-flax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Jason B Turowski, MD, University of Pennsylvania; Principal Investigator: Denis Hadjiliadis, MD, University of Pennsylvania; Principal Investigator: Melpo Christofidou-Solomidou, Ph.D., University of Pennsylvania

Publications and helpful links

General Publications

• 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 ADVANCES IN CYSTIC FIBROSIS / Mini Symposium / Sunday, May 19/2:00 PM-4:30 PM / Room 204 A-B (200 Level) Pennsylvania Convention Center
• Turowski JB, Pietrofesa RA, Lawson JA, Christofidou-Solomidou M, Hadjiliadis D. Flaxseed modulates inflammatory and oxidative stress biomarkers in cystic fibrosis: a pilot study. BMC Complement Altern Med. 2015 May 13;15:148. doi: 10.1186/s12906-015-0651-2.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: November 27, 2013
• First Submitted That Met QC Criteria: December 11, 2013
• First Posted (Estimate): December 18, 2013

Study Record Updates

• Last Update Posted (Estimate): January 7, 2014
• Last Update Submitted That Met QC Criteria: January 6, 2014
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: inflammation; cystic fibrosis; oxidative stress; flaxseed; enterolactone; enterodiol; isoprostanes; 8-oxo-dGuo
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Inflammation; Cystic Fibrosis
• Other Study ID Numbers: 815533