Single Oral Dose of BeneFlax to Healthy Young and Older Adults

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 2, Hypercholesterolemia

Intervention / Treatment
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* Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeneFlax<br>BeneFlax given as a single oral dose to assess pharmacokinetics | Other: BeneFlax - 38% secoisolariciresinol diglucoside (SDG)<br>* 0.8g of BeneFlax (contains 300mg SDG) given once by mouth<br>* Other names: Secoisolariciresinol diglucoside (SDG);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Activity questionnaire | Background information about participants usual physical activities will be collected once prior to study commencement. | at 0 hours - prior to study commencement | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Flaxseed, Lignans, Pharmacokinetics