Flaxseed Modulates Inflammation and Oxidative Stress in CF

NCT02014181 | Completed Phase 1

• 1 other identifier: 815533
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis; Oxidative Stress; Inflammation

Keywords

cystic fibrosis; isoprostanes; 8-oxo-dGuo; oxidative stress; inflammation; flaxseed; enterodiol; enterolactone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measure levels of flaxseed metabolism in the blood of patients with cystic fibrosis

  one month

• Measure biomarkers of systemic oxidative stress

  one month

Study Arms (1)

Flaxseed

EXPERIMENTAL

40 grams finely ground flaxseed powder daily for one month in patient with cystic fibrosis

Dietary Supplement: finely ground flaxseed powder

Interventions

finely ground flaxseed powder DIETARY_SUPPLEMENT

40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis

Also known as: flaxseed, Flax, Linseed oil, SDG, Bene-flax

Flaxseed

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

• 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

  RESULT

• 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.

  PMID: 25963404 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis; Inflammation

Interventions

Linseed Oil

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fats, Unsaturated; Fats; Lipids; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 18, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 7, 2014

Record last verified: 2012-04

Locations

US (1)