Skip to main content
OpenTrials
Completed

NCT Number: NCT01531569

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 0M7, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BeneFlax - 38% secoisolariciresinol diglucoside (SDG)

Other

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

Other names: Secoisolariciresinol diglucoside (SDG)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Collaborators

  • Saskatchewan Health Research Foundation

Registry information

Official study title

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

Acronym: SOD

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2012
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.