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Flaxseed Modulates Inflammation and Oxidative Stress in CF

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02014181
First Posted: December 18, 2013
Last Update Posted: January 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Cystic Fibrosis Oxidative Stress Inflammation Dietary Supplement: finely ground flaxseed powder Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Number of patients with side effects secondary to flaxseed ingestion [ Time Frame: one month ]
    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.


Secondary Outcome Measures:
  • Measure levels of flaxseed metabolism in the blood of patients with cystic fibrosis [ Time Frame: one month ]
    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.

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


Enrollment: 10
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • flaxseed
  • Flax
  • Linseed oil
  • SDG
  • Bene-flax

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014181


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
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
  More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02014181     History of Changes
Other Study ID Numbers: 815533
First Submitted: November 27, 2013
First Posted: December 18, 2013
Last Update Posted: January 7, 2014
Last Verified: April 2012

Keywords provided by University of Pennsylvania:
cystic fibrosis
isoprostanes
8-oxo-dGuo
oxidative stress
inflammation
flaxseed
enterodiol
enterolactone

Additional relevant MeSH terms:
Fibrosis
Inflammation
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases