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Single Oral Dose of BeneFlax to Healthy Young and Older Adults

NCT ID: NCT01531569

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-06-30

Brief Summary

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This study is being done to look at age differences in the way the investigators bodies break down a compound found in flax seed (secoisolariciresinol diglucoside or SDG). It is administered to research subjects in a product called BeneFlax, which a concentrated version of flax seed containing 38% SDG.

It is known that as people age, their bodies undergo physical changes both on the outside and the inside. The aging process may change the way that the investigators bodies deal with compounds the investigators eat. As an important measure of safety, the investigators want to check for evidence whether there is a difference in break down of SDG between different age groups.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Hypercholesterolemia

Keywords

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Flaxseed Lignans Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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BeneFlax

BeneFlax given as a single oral dose to assess pharmacokinetics

Group Type EXPERIMENTAL

BeneFlax - 38% secoisolariciresinol diglucoside (SDG)

Intervention Type OTHER

0.8g of BeneFlax (contains 300mg SDG) given once by mouth

Interventions

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BeneFlax - 38% secoisolariciresinol diglucoside (SDG)

0.8g of BeneFlax (contains 300mg SDG) given once by mouth

Intervention Type OTHER

Other Intervention Names

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Secoisolariciresinol diglucoside (SDG)

Eligibility Criteria

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Inclusion Criteria

* Healthy adults: 18-45 and 60-80 years of age

Exclusion Criteria

* Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
* Strict vegetarians and vegans (as these diets likely contain foods which have higher levels of lignans)
* Individuals who smoke
* Individuals who have experienced diarrhea in the last three months
* Individuals who have taken oral antibiotics in the last three months
* Individuals who are currently taking warfarin or any of its derivatives
* Individuals with low haemoglobin (\<121g/L for women and \<137g/L for men)
* Individuals with BMI under 19 or over 28
* Pregnant or lactating women
* Women with child bearing potential not using contraceptives
* Current diagnosis of a bleeding disorder or at risk of bleeding
* Individuals with gastrointestinal problems (such as ulcers), or convulsive, depressive, or hepatic disorders
* Individuals with diabetes mellitus
* Individuals currently taking a flax seed supplement
* Individuals with an allergy to flax seed
* Individuals who have donated blood or lost \> 450 mL of blood within 56 days of study duration
* Individuals who have participated in any other clinical trial with and investigational agent within one month of starting this trial
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Saskatchewan Health Research Foundation

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role lead

Responsible Party

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Jane Alcorn

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jane Alcorn, DVM, PhD

Role: PRINCIPAL_INVESTIGATOR

College of Pharmacy & Nutrition, University of Saskatchewan

Locations

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Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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NHPD - 174041

Identifier Type: -

Identifier Source: org_study_id