Flaxseed Lignan Enriched Complex for Blood Pressure Reduction in Elderly Participants With High Normal Blood Pressure or Stage I Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in 24 h ambulatory systolic blood pressure
研究概览
简要总结
Current recommendations today suggest that use of therapeutic lifestyle changes, such as supplementation with specific dietary components and moderate exercise, are appropriate interventions for individuals with borderline high blood pressure. Dietary intervention with natural products, such as flaxseed, is associated with decreased prevalence of cardiovascular disease (Adolphe 2010). Lignans are the active compounds in flaxseed believed to mediate the cardiovascular health benefits following flaxseed consumption (Peterson 2010). Clinical trials indicate benefit of Flax Lignan Enriched Complex (FLC) (BeneFlax® from Archer Daniels Midland, a natural product derived from flaxseed composed of 34-38% lignan) for reducing blood cholesterol and glucose (Pan 2007; Zhang 2008) and blood pressure (Cornish 2009). Furthermore, a recent study in atherosclerosis patients showed significant clinical benefit of flaxseed meal for reducing blood pressure (Rodriguez-Leyva 2013). As a therapeutic lifestyle change that could prevent a need to introduce drug therapy in elderly patients, the effectiveness of FLC supplementation alone or in combination with moderate exercise merits investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •High normal blood pressure (130/85 - 139/89) or stage I hypertension (140/90 - 150/90)
- •Ability to follow simple instructions
排除标准
- •Age below 60 years.
- •Individuals living in long term care homes.
- •Individuals unable to walk for 30 minutes.
- •Unstable diabetes, or diabetics taking insulin (note: eligible diabetic participants will undergo additional testing during the study ).
- •Current cancer or diagnosed with cancer in the past 2 years.
- •Significant liver or other gastrointestinal disorder including inflammatory bowel disease. (While constipation is the most common gastrointestinal problem in the elderly, it would not be a contraindication)
- •Significant kidney disorder.
- •Have taken oral antibiotics in the past three months
- •Unstable or severe cardiac disease, recent myocardial infarction, or stroke (either in past 6 months or significantly 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 immune-compromise.
- •Current use of hormone replacement therapy (except thyroid).
- •Current use of blood pressure medications and/or diuretics
- •Current use of flax seed supplement
- •Participation in any other clinical trial with an investigational agent within one month prior to randomization.
研究组 & 干预措施
BeneFlax® + walking training (Dash)
BeneFlax (0.8 g, twice a day) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: BeneFlax® (Dietary Supplement)
BeneFlax® + walking training (Dash)
BeneFlax (0.8 g, twice a day) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Walking training (Behavioral)
BeneFlax® + walking training (Dash)
BeneFlax (0.8 g, twice a day) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Dash Eating Plan (Behavioral)
Placebo + walking training (Dash)
Placebo (whey powder isocaloric to BeneFlax) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Walking training (Behavioral)
Placebo + walking training (Dash)
Placebo (whey powder isocaloric to BeneFlax) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Placebo (Whey Protein) (Dietary Supplement)
Placebo + walking training (Dash)
Placebo (whey powder isocaloric to BeneFlax) with exercise training (30-60 minutes walking training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Dash Eating Plan (Behavioral)
BeneFlax® + flexibility training (Dash)
BeneFlax (0.8 g, twice a day) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: BeneFlax® (Dietary Supplement)
BeneFlax® + flexibility training (Dash)
BeneFlax (0.8 g, twice a day) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Flexibility training (Behavioral)
BeneFlax® + flexibility training (Dash)
BeneFlax (0.8 g, twice a day) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Dash Eating Plan (Behavioral)
Placebo + flexibility training (Dash)
Placebo (whey powder isocaloric to BeneFlax) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Walking training (Behavioral)
Placebo + flexibility training (Dash)
Placebo (whey powder isocaloric to BeneFlax) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Flexibility training (Behavioral)
Placebo + flexibility training (Dash)
Placebo (whey powder isocaloric to BeneFlax) with placebo exercise training (flexibility training, 5 times a week) for 8 weeks; all participants encouraged to follow Dash Eating Plan.
干预措施: Dash Eating Plan (Behavioral)
结局指标
主要结局
Change in 24 h ambulatory systolic blood pressure
时间窗: Baseline, week 4, and week 8
Reduction in 24 h ambulatory systolic blood pressure at midpoint (week 4) and end (week 8) of the intervention relative to baseline value is the primary outcome of the intervention.
次要结局
- Heart rate(Baseline)
- Glucometer fasting blood glucose(Week 8)
- Change in Body composition by DXA (Dual-energy X-ray absorptiometry)(Baseline, week 4, and week 8)
- Change in body weight(Baseline, week 4, and week 8)
- Change in lying and standing blood pressure(Baseline, week 4, and week 8)
- Block Food Frequency Questionnaire(Week 8)
- Heart Rate(Week 8)
- Change in blood markers of safety and cardiovascular disease risk factors (clinical biochemical panel including fasting glucose, lipids, cholesterol, electrolytes, C-reactive protein)(Baseline, week 4, and week 8)
- Blood levels of the flax lignan, secoisolariciresinol diglucoside (SDG), and its metabolites(Week 8)
- Physical activity assessment tool (PASE)(Baseline)
- Respiratory rate(Week 8)
研究者
Jane Alcorn
PhD
University of Saskatchewan