Single Oral Dose of BeneFlax to Healthy Young and Older Adults (SOD)

Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Hypercholesterolemia
• Intervention / Treatment: Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0M7
      • Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BeneFlax; BeneFlax given as a single oral dose to assess pharmacokinetics	Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG); 0.8g of BeneFlax (contains 300mg SDG) given once by mouth; Other Names: Secoisolariciresinol diglucoside (SDG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone.	Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.	0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone.	Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.	0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Area under the plasma concentration versus time curve (AUC) of secoisolariciresinol, enterodiol and enterolactone.	Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.	0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Elimination rate constant (k) of secoisolariciresinol, enterodiol and enterolactone.	Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.	0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose
Terminal phase half-life of secoisolariciresinol, enterodiol and enterolactone.	Blood samples will be collected at baseline and then post-dosing: every three hours for the first 48 hours, once at 72 hours and once at 96 hours. The concentrations of secoisolariciresinol, enterodiol and enterolactone will be quantitated at each time point.	0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Food frequency questionnaire	Background information about participants usual dietary choices will be collected once prior to study commencement.	at 0 hours - prior to study commencement
Activity questionnaire	Background information about participants usual physical activities will be collected once prior to study commencement.	at 0 hours - prior to study commencement
Inflammatory markers	Measurement of the inflammatory markers interleukin-1a, interleukin-1b, interleukin-6 and TNF-a to determine participants baseline levels. The levels will only be tested once prior to study commencement	at 0 hours - prior to study commencement

Collaborators and Investigators

• Sponsor: University of Saskatchewan
• Collaborators: Saskatchewan Health Research Foundation
• Investigators: Principal Investigator: Jane Alcorn, DVM, PhD, College of Pharmacy & Nutrition, University of Saskatchewan

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 9, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 25, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Flaxseed; Lignans
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Diabetes Mellitus, Type 2; Hypercholesterolemia; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens, Non-Steroidal; Estrogens; Phytoestrogens; Secoisolariciresinol
• Other Study ID Numbers: NHPD - 174041