Single Oral Dose of BeneFlax to Healthy Young and Older Adults - Full Text View

Purpose

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	Intervention	Phase
Diabetes Mellitus, Type 2 Hypercholesterolemia	Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Diabetes Diabetes Type 2

U.S. FDA Resources

Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]
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.
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 ] [ Designated as safety issue: Yes ]
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.
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 ] [ Designated as safety issue: Yes ]
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.
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 ] [ Designated as safety issue: Yes ]
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.
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 ] [ Designated as safety issue: Yes ]
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:

Food frequency questionnaire [ Time Frame: at 0 hours - prior to study commencement ] [ Designated as safety issue: No ]
Background information about participants usual dietary choices will be collected once prior to study commencement.
Activity questionnaire [ Time Frame: at 0 hours - prior to study commencement ] [ Designated as safety issue: No ]
Background information about participants usual physical activities will be collected once prior to study commencement.
Inflammatory markers [ Time Frame: at 0 hours - prior to study commencement ] [ Designated as safety issue: Yes ]
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

Enrollment:	22
Study Start Date:	December 2011
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531569

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

No publications provided

Responsible Party:	University of Saskatchewan
ClinicalTrials.gov Identifier:	NCT01531569 History of Changes
Other Study ID Numbers:	NHPD - 174041
Study First Received:	January 9, 2012
Last Updated:	April 30, 2013
Health Authority:	Canada: Health Canada Canada: Ethics Review Committee

Keywords provided by University of Saskatchewan:

Flaxseed
Lignans
Pharmacokinetics

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypercholesterolemia
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013

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