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Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment

NCT02201758 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-05

No results posted yet for this study

Summary

This study proposes to examine the effect of diet as a modifiable risk factor among patients with ulcerative colitis (UC). Flax seeds contain many bioactive constituents which have anti-oxidative, anti-inflammatory, and anti-carcinogenic effects. These bioactive compounds represent novel classes of pharmacologically active compounds which may represent new options to treat chronic disease of the gastrointestinal tract. Participants with mild to moderately severe UC will supplement their current medications with flaxseed lignan-enriched complex (FLC). This is a 12 week double blind placebo controlled study with assessment throughout. Stool and blood samples (biomarkers) as well as bowel assessment via sigmoidoscopy will be evaluated before and after the intervention. The treatment arm consists of 300 mg FLC taken orally twice daily.

Conditions

Interventions

DIETARY_SUPPLEMENT

Flaxseed lignan-enriched complex (FLC)

Subjects will undergo treatment with FLC for an 8-week period; participants will take 300 mg flaxseed lignan-enriched complex (FLC) taken orally twice daily

OTHER

Placebo

Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)

Sponsors & Collaborators

  • Royal University Hospital Foundation

    collaborator OTHER

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Sharyle Fowler, MD,FRCPS · University of Saskatchewan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02201758 on ClinicalTrials.gov