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| Name | Class |
|---|---|
| Saskatchewan Health Research Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BeneFlax | Experimental | BeneFlax given as a single oral dose to assess pharmacokinetics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BeneFlax - 38% secoisolariciresinol diglucoside (SDG) | Other | 0.8g of BeneFlax (contains 300mg SDG) given once by mouth |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jane Alcorn, DVM, PhD | College of Pharmacy & Nutrition, University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saskatoon Centre for Patient Oriented Research - Saskatoon City Hospital | Saskatoon | Saskatchewan | S7K 0M7 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C090142 | secoisolariciresinol diglucoside |
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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 |
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 |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |