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| Name | Class |
|---|---|
| Saskatchewan Health Research Foundation | OTHER |
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A major means whereby oxidative stress promotes aging-related disease is by activating inflammatory pathways. Decreasing oxidative stress and inflammation should ameliorate many of the problems associated with aging, including vascular dementia, Alzheimer's disease, osteoporosis, muscle wasting, insulin resistance, type 2 diabetes, and metabolic syndrome. Animal and human studies have demonstrated that consumption of vitamin D and phase 2 protein inducers decrease oxidative stress and associated inflammation. The flax lignan secoisolariciresinol diglucoside (SDG) is metabolized to enterolactone, a potent phase 2 protein inducer. Animal and human studies have shown that consumption of flax seed or its component SDG decreases hypertension, serum cholesterol, atherosclerosis, the growth of experimentally-induced cancers as well as metastases of human breast tumours implanted into nude mice, and delays the development of type 2 diabetes. Vitamin D plays a role in modulating inflammation, enhancing immunity (while suppressing autoimmune injury) and exerting control over cell differentiation. Adequate levels of vitamin D also appear to promote better glycemic control. The investigators predict that consumption of SDG in persons with adequate vitamin D status will decrease oxidative stress and associated inflammation. If this hypothesis is upheld, this research has the potential to greatly decrease healthcare costs while allowing healthier aging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| secoisolariciresinol diglucoside | Active Comparator | Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care. |
|
| Placebo | Placebo Comparator | An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| secoisolariciresinol diglucoside | Dietary Supplement | SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y) | Adverse event occurrences will be compared descriptively between the SDG and placebo groups. Safety will be assessed at 0, 6, 12, 18 and 24 weeks; as part of the blood collection (urea, creatinine, total bilirubin, platelets, hematocrit, haemoglobin, mean corpuscular haemoglobin, mean corpuscular volume, white blood cell count, total protein including albumin and prealbumin, total calcium, electrolytes, glucose, liver enzymes (AST, ALT, ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure measurements will be performed every two weeks | 24 weeks |
| Effect of SDG on oxidative stress and inflammation | SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in oxidative stress measurements (plasma malondialdehyde), pro-inflammatory markers (IL-6, IL-1α, IL-1β, 8-isoprostane, TNF-α, C-reactive protein). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of SDG on quality of life | SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in cognitive function, pain, and physical function including falls, as well as performance of activities of daily living. | 24 weeks |
| Effect of SDG supplement on blood levels of flax lignan metabolites |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Whiting, PhD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saskatoon Health Region | Saskatoon | Saskatchewan | S7K 5T6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20003621 | Background | Adolphe JL, Whiting SJ, Juurlink BH, Thorpe LU, Alcorn J. Health effects with consumption of the flax lignan secoisolariciresinol diglucoside. Br J Nutr. 2010 Apr;103(7):929-38. doi: 10.1017/S0007114509992753. Epub 2009 Dec 15. | |
| 28922068 | Result | Di Y, Jones J, Mansell K, Whiting S, Fowler S, Thorpe L, Billinsky J, Viveky N, Cheng PC, Almousa A, Hadjistavropoulos T, Alcorn J. Influence of Flaxseed Lignan Supplementation to Older Adults on Biochemical and Functional Outcome Measures of Inflammation. J Am Coll Nutr. 2017 Nov-Dec;36(8):646-653. doi: 10.1080/07315724.2017.1342213. Epub 2017 Sep 18. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D003704 | Dementia |
| D010146 | Pain |
| D003863 | Depression |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C090142 | secoisolariciresinol diglucoside |
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To further understand the pharmacology of SDG, we will analyze plasma levels of the SDG metabolites secoisolariciresinol, enterolactone and enterodiol in those subjects given flax lignan supplement. Levels will be determined 0, 12 and 24 weeks. |
| 24 weeks |
| To measure effects of SDG on bone resorption | SDG and placebo groups will be compared at 0 and 24 weeks for changes in bone resorption as assessed by measurement of cross-linked N-telopeptides type I collagen serum levels. | 24 weeks |
| Effect of SDG on blood lipids | SDG and placebo groups will be compared at 0, 12 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides. | 24 weeks |
| 28159728 | Result | Alcorn J, Whiting S, Viveky N, Di Y, Mansell K, Fowler S, Thorpe L, Almousa A, Cheng PC, Jones J, Billinsky J, Hadjistavropoulos T. Protocol for a 24-Week Randomized Controlled Study of Once-Daily Oral Dose of Flax Lignan to Healthy Older Adults. JMIR Res Protoc. 2017 Feb 3;6(2):e14. doi: 10.2196/resprot.6817. |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |