Skip to main content
OpenTrials
Completed

NCT Number: NCT02014181

Flaxseed Modulates Inflammation and Oxidative Stress in CF

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

finely ground flaxseed powder

Dietary Supplement

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

Other names: flaxseed, Flax, Linseed oil, SDG, Bene-flax

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Dec 18, 2013
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.