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Flaxseed Modulates Inflammation and Oxidative Stress in CF

Primary Purpose

Cystic Fibrosis, Oxidative Stress, Inflammation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

finely ground flaxseed powder

About this trial

This is an interventional prevention trial for Cystic Fibrosis focused on measuring cystic fibrosis, isoprostanes, 8-oxo-dGuo, oxidative stress, inflammation, flaxseed, enterodiol, enterolactone

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flaxseed

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02014181

First Posted

November 27, 2013

Last Updated

January 6, 2014

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT02014181

Brief Title

Flaxseed Modulates Inflammation and Oxidative Stress in CF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis, Oxidative Stress, Inflammation

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flaxseed

Arm Type

Experimental

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

finely ground flaxseed powder

Other Intervention Name(s)

flaxseed, Flax, Linseed oil, SDG, Bene-flax

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients with side effects secondary to flaxseed ingestion

Description

Time Frame

one month

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

one month

Title

Measure biomarkers of systemic oxidative stress

Description

Time Frame

one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jason B Turowski, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Denis Hadjiliadis, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Melpo Christofidou-Solomidou, Ph.D.

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

PubMed Identifier

25963404

Citation

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.

Results Reference

derived

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Flaxseed Modulates Inflammation and Oxidative Stress in CF

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