Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Metabolic syndrome score
研究概览
简要总结
The investigators specific objective is to determine the effectiveness of a pulse-based diet combined with an exercise training program for reducing the risk of metabolic syndrome in older adults. The metabolic syndrome is a cluster of risk factors that predispose one to the development of diabetes and cardiovascular disease. These risk factors include increased abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high blood pressure, high blood glucose and insulin levels, and increased inflammation. The investigators hypothesize that a pulse-based diet combined with exercise training will be very effective for reducing the risks of the metabolic syndrome because each intervention acts on different components of the metabolic syndrome.
The design will involve a randomized single-blind cross-over for the pulse-based diet, and a single blind randomized parallel group assignment for the exercise-based intervention. 100 subjects will be randomized to receive the pulse-based diet or their regular diet for 2 months and then cross-over to receive the opposite diet for 2 months, separated by a one-month "wash out". Subjects will be further randomized to exercise or "exercise placebo" groups for the duration of the trial (i.e. 5 months). The exercise intervention will involve aerobic training as this is most effective for reducing metabolic syndrome risk.
Dependent variables will be measured at 4 time points: baseline, after the first 2-month diet, before the second 2-month diet (i.e. after the washout) and at the end of the second 2-month diet. These variables will include: Serum triglycerides, high density lipoproteins, C-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and blood pressure. A composite metabolic syndrome score will be determined by converting each of these variables into Z-scores and determining the mean of these Z-scores. Secondary variables will include other serum lipids, including low density lipoproteins and total cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women over the age of 50y
排除标准
- •allergies to beans, peas, lentils, chickpeas
- •currently taking medication for blood lipids
- •currently engaged in vigorous aerobic activity greater than 2 times per week
结局指标
主要结局
Metabolic syndrome score
时间窗: baseline, 2 months, 3 months, 5 months
次要结局
- Lean body mass(baseline, 2 months, 3 months, 5 months)
- Plasma glucose(baseline, 2 months, 3 months, 5 months)
- Plasma insulin(baseline, 2 months, 3 months, 5 months)
- High density lipoproteins(baseline, 2 months, 3 months, 5 months)
- Triacylglycerol(baseline, 2 months, 3 months, 5 months)
- Waist circumference(baseline, 2 months, 3 months, 5 months)
- C-reactive protein(baseline, 2 months, 3 months, 5 months)
- Lumbar spine bone mineral(baseline, 2 months, 3 months, 5 months)
- Fat mass(baseline, 2 months, 3 months, 5 months)
- Whole body bone mineral(baseline, 2 months, 3 months, 5 months)
- Hip bone mineral(baseline, 2 months, 3 months, 5 months)
- Low density lipoproteins(baseline, 2 months, 3 months, 5 months)
- Total cholesterol(baseline, 2 months, 3 months, 5 months)
- Blood Pressure(baseline, 2 months, 3 months, 5 months)
- Aerobic fitness - modified Canadian Test of Fitness(baseline, 2 months, 3 months, 5 months)
- Strength(baseline, 2 months, 3 months, 5 months)
研究者
Phil Chilibeck
Professor
University of Saskatchewan
