Clinical trial NCT01531569: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
Official title: Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Hypercholesterolemia
Keywords: Flaxseed
Lignans
Pharmacokinetics
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: Saskatchewan Health Research Foundation
First posted: 2012-02-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone.
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
measure: Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone.
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
measure: Area under the plasma concentration versus time curve (AUC) of secoisolariciresinol, enterodiol and enterolactone.
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
measure: Elimination rate constant (k) of secoisolariciresinol, enterodiol and enterolactone.
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
measure: Terminal phase half-life of secoisolariciresinol, enterodiol and enterolactone.
timeFrame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Secondary outcomes:
measure: Food frequency questionnaire
timeFrame: at 0 hours - prior to study commencement
measure: Activity questionnaire
timeFrame: at 0 hours - prior to study commencement
measure: Inflammatory markers
timeFrame: at 0 hours - prior to study commencement
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital
state: Saskatchewan
Study officials:
affiliation: College of Pharmacy & Nutrition, University of Saskatchewan
name: Jane Alcorn, DVM, PhD
role: PRINCIPAL_INVESTIGATOR
References: