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临床试验/NCT00800033
NCT00800033已完成3 期

Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2008年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Phil Chilibeck

Professor

University of Saskatchewan

研究点 (2)

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