Community Alliance for Quality of Life in Long Term Care: Oxidative Stress and Nutritional Supplementation Intervention Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults residing in a long term care facility
- •resident for a minimum of four weeks prior to entry
- •able to comply with study protocol
- •able to follow simple instructions
- •able to give informed consent or has a legally acceptable representative who is able to provide consent
排除标准
- •Age below 60 or above 80 years.
- •Individuals at risk of hypotension or with symptomatic hypotension.
- •Fasting hypoglycemia.
- •Unstable diabetes
- •Diabetics taking insulin
- •Current cancer or diagnosed with cancer in the past 2 years.
- •Women with an immediate family history or personal history of breast cancer or ovarian cancer
- •Significant liver disorder
- •Significant gastrointestinal disorder including inflammatory bowel disease but not constipation
- •Significant kidney disorder
- •Unstable or severe cardiac disease, recent MI or stroke either in past 6 months or significantly (i.e., severely) affecting physical mobility.
- •Unstable other medical disease including, but not limited to, pulmonary disorder, epilepsy and genitourinary disorder.
- •Migraine with aura within the last year (as this is a risk factor for stroke).
- •Current diagnosis of a bleeding condition, or at risk of bleeding.
- •Significant immunocompromise.
- •Other unstable conditions.
- •Current use of hormone replacement therapy except thyroid medication
- •Current use of warfarin, clopidogrel, ticlopidine, dipyridamole or their analogues.
- •Intolerances or allergies to flax or vitamin D.
- •Estimated probability of longevity of less than one year based on medical opinion
研究组 & 干预措施
Placebo
An equal volume of measured whey protein (unflavored) to the Beneflax and 1000 IU vitamin D as standard of care.
干预措施: secoisolariciresinol diglucoside (Dietary Supplement)
secoisolariciresinol diglucoside
Secoisolariciresinol diglucoside (SDG) supplementation as 0.8g/day of BeneFlax containing 300 mg SDG. 1000 IU vitamin D as standard of care.
干预措施: secoisolariciresinol diglucoside (Dietary Supplement)
结局指标
主要结局
Safety of consumption of 300 mg/day of the flax lignan secoisolariciresinol diglucoside (SDG) in older adults (60-80 y)
时间窗: 24 weeks
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
Effect of SDG on oxidative stress and inflammation
时间窗: 24 weeks
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).
次要结局
- Effect of SDG supplement on blood levels of flax lignan metabolites(24 weeks)
- To measure effects of SDG on bone resorption(24 weeks)
- Effect of SDG on blood lipids(24 weeks)
- Effect of SDG on quality of life(24 weeks)
研究者
Susan Whiting
PhD
University of Saskatchewan