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| Name | Class |
|---|---|
| Saskatchewan Health Research Foundation | OTHER |
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The investigators are investigating whether the flax lignan, secoisolariciresinol diglucoside, decreases oxidative stress and inflammation. The flax seed lignan is believed to be broken down in the body to produce the health benefits of flax. Flax lignan is separated from the whole flax seed as this compound is believed to have health effects. Decreasing oxidative stress and inflammation should improve a number of the problems associated with aging. This intervention consists of 600 milligrams of the flax lignan SDG daily or an equivalent amount of whey protein.
The investigators are comparing lignan to a placebo (whey powder) to examine whether a dietary intervention (i.e. flax seed containing lignan) might decrease oxidative stress and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| secoisolariciresinol diglucoside | Active Comparator | Secoisolariciresinol diglucoside (SDG) supplementation as 1.6g/day of BeneFlax containing 600 mg SDG. 1000 IU vitamin D as standard of care. |
|
| Whey powder | Placebo Comparator | Natural Factors Whey Factors whey protein (unflavored). 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, vitamin D | Dietary Supplement | SDG supplementation as a packet of 1.6g/day of BeneFlax containing 600 mg SDG for 24 weeks Vitamin D Natural Product Number (NPN) 80003663 WN Pharmaceuticals Natural Factors Whey Factors |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of consumption of 600 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, 8, 16 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 (Aspartate transaminase (AST), Alanine Aminotransferase (ALT), Alkaline phosphatase (ALP), total protein, albumin, lipids, HbA1c (for diabetic participants). Blood pressure, pulse and respiratory rate will also be monitored at these time points. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of SDG on blood lipids | SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in nonfasting levels of cholesterol, LDL, HDL, and triglycerides. | 24 weeks |
| Effect of SDG on inflammation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Jones, MD, FRCPC | University of Saskatchewan | Principal Investigator |
| Jane Alcorn, DVD, PhD | University of Saskatchewan | Study Chair |
| Susan Whiting, PhD | University of Saskatchewan | Study Chair |
| Kerry Mansell, BSP, PharmD | University of Saskatchewan | Study Chair |
| Sharyle Fowler, MD | University of Saskatchewan | Study Chair |
| Lilian Thorpe, MD, PhD | University of Saskatchewan | Study Chair |
| Thomas Hadjistavropoulos, PhD, RD | University of Regina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saskatoon Centre for Patient-Oriented Research | Saskatoon | Saskatchewan | S7K 0M7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28159728 | Derived | 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. |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010146 | Pain |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C090142 | secoisolariciresinol diglucoside |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in pro-inflammatory markers (Interleukin-6 (IL-6), IL-1α, IL-1β, 8-isoprostane, Tumor necrosis factor-α (TNF-α), C-reactive protein).
| 24 weeks |
| Effect of SDG on quality of life | SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function. | 24 weeks |
| Effect of SDG supplement on blood levels of flax lignan metabolites | SDG and placebo groups will be compared at 0, 8, 16 and 24 weeks for changes in cognitive function, pain, and physical function. | 24 weeks |
| Effect of SDG supplement on fecal levels of flax lignan metabolites | To further understand the pharmacology of SDG, we will analyze fecal levels of the flax cyclolinopeptides. Levels will be determined 0 and 24 weeks. | 24 weeks |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009422 | Nervous System Diseases |