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

• ClinicalTrials.gov Identifier: NCT01531569
• Recruitment Status: Completed
• First Posted: February 13, 2012
• Last Update Posted: October 26, 2016
• Sponsor: University of Saskatchewan
• Collaborator: Saskatchewan Health Research Foundation
• Information provided by (Responsible Party): Jane Alcorn, University of Saskatchewan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Hypercholesterolemia	Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
• Study Start Date: December 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

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 Name: Secoisolariciresinol diglucoside (SDG)

Outcome Measures

Primary Outcome Measures :

1. Peak plasma concentration (Cmax) of secoisolariciresinol, enterodiol and enterolactone. [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose ]
   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.
2. Time to reach peak plasma concentration (tmax) of secoisolariciresinol, enterodiol and enterolactone. [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose ]
   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.
3. Area under the plasma concentration versus time curve (AUC) of secoisolariciresinol, enterodiol and enterolactone. [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose ]
   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.
4. Elimination rate constant (k) of secoisolariciresinol, enterodiol and enterolactone. [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose ]
   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.
5. Terminal phase half-life of secoisolariciresinol, enterodiol and enterolactone. [ Time Frame: 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 72, 96 hours post-dose ]
   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.

Secondary Outcome Measures :

1. Food frequency questionnaire [ Time Frame: at 0 hours - prior to study commencement ]
   Background information about participants usual dietary choices will be collected once prior to study commencement.
2. Activity questionnaire [ Time Frame: at 0 hours - prior to study commencement ]
   Background information about participants usual physical activities will be collected once prior to study commencement.
3. Inflammatory markers [ Time Frame: at 0 hours - prior to study commencement ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Canada, Saskatchewan

Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada, S7K 0M7

Sponsors and Collaborators

University of Saskatchewan

Saskatchewan Health Research Foundation

Investigators

• Principal Investigator: Jane Alcorn, DVM, PhD; College of Pharmacy & Nutrition, University of Saskatchewan

More Information

• Responsible Party: Jane Alcorn, Ph.D., University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT01531569
• Other Study ID Numbers: NHPD - 174041
• First Posted: February 13, 2012
• Last Update Posted: October 26, 2016
• Last Verified: October 2016

Keywords provided by Jane Alcorn, University of Saskatchewan:

Flaxseed; Lignans; Pharmacokinetics

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Hypercholesterolemia; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Secoisolariciresinol; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs