Flaxseed Modulates Inflammation and Oxidative Stress in CF
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|ClinicalTrials.gov Identifier: NCT02014181|
Recruitment Status : Completed
First Posted : December 18, 2013
Last Update Posted : January 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Oxidative Stress Inflammation||Dietary Supplement: finely ground flaxseed powder||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||January 2013|
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
- 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.
- 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.
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
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|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|