Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531569
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Saskatchewan Health Research Foundation
Information provided by (Responsible Party):
Jane Alcorn, University of Saskatchewan

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE December 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2012)
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single Oral Dose of BeneFlax to Healthy Young and Older Adults
Official Title  ICMJE Community Alliance for Quality of Life in Long Term Care: Single Oral Dose of BeneFlax to Healthy Young and Older Adults
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Hypercholesterolemia
Intervention  ICMJE Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)
0.8g of BeneFlax (contains 300mg SDG) given once by mouth
Other Name: Secoisolariciresinol diglucoside (SDG)
Study Arms  ICMJE Experimental: BeneFlax
BeneFlax given as a single oral dose to assess pharmacokinetics
Intervention: Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 20, 2012)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2012)
24
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531569
Other Study ID Numbers  ICMJE NHPD - 174041
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jane Alcorn, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE Saskatchewan Health Research Foundation
Investigators  ICMJE
Principal Investigator: Jane Alcorn, DVM, PhD College of Pharmacy & Nutrition, University of Saskatchewan
PRS Account University of Saskatchewan
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP