Single Oral Dose of BeneFlax to Healthy Young and Older Adults

Diabetes Mellitus, Type 2 Clinical Trial

— SOD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531569
• Other study ID #: NHPD - 174041
• Status: Completed
• Phase: Phase 2
• First received: January 9, 2012
• Last updated: October 25, 2016
• Start date: December 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2016
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypercholesterolemia

Intervention

Other:
• BeneFlax - 38% secoisolariciresinol diglucoside (SDG)
0.8g of BeneFlax (contains 300mg SDG) given once by mouth

Locations

Country	Name	City	State
Canada	Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital	Saskatoon	Saskatchewan

Sponsors (2)

Lead Sponsor	Collaborator
University of Saskatchewan	Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	Activity questionnaire	Background information about participants usual physical activities will be collected once prior to study commencement.	at 0 hours - prior to study commencement	No
Secondary	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	Yes