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临床试验/NCT00204412
NCT00204412已完成3 期

Effectiveness of Flax Lignan and Exercise Training for Improving Lipid Profiles

University of Saskatchewan2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年3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
100
试验地点
2
主要终点
metabolic syndrome score

研究概览

简要总结

The purpose of our study is to use a flaxseed-based nutritional supplement in combination with exercise training (walking) for improving cholesterol levels. We hypothesize that exercise training will improve cholesterol profile and that adding supplementation with a flaxseed nutritional supplement will further improve cholesterol profile.

详细描述

Flax supplementation and exercise training each have small beneficial effects for improving blood lipid profile and reducing cardiovascular disease risk. Flax lignan, a phytoestrogen found in flaxseed is thought to be the active compound responsible for the cholesterol-lowering effect of flaxseed. Our purpose is to combine an exercise training program (walking) with flax lignan supplementation for improving blood lipid profile.

Comparisons: Walking (6 days per week) plus flax lignan (500 mg per day) compared to walking plus placebo.

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
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50 years or older

排除标准

  • Currently taking medication for cholesterol
  • Gastrointestinal disease
  • Females on hormone replacement therapy
  • Currently taking a flaxseed supplement
  • Currently engaged in vigorous exercise training

结局指标

主要结局

metabolic syndrome score

时间窗: 6 months

次要结局

  • Total cholesterol at 2, 4, and 6 months(6 months)
  • Aerobic fitness at 6 months(6 months)
  • Body mass index at 6 months(6 months)
  • Lumbar spine bone mineral density at 6 months(6 months)
  • Whole body bone mineral density at 6 months(6 months)
  • inflammatory cytokines(6 months)
  • High density lipoprotein at 2, 4, and 6 months(6 months)
  • Triglycerides at 2, 4, and 6 months(6 months)
  • Blood glucose at 2, 4, and 6 months(6 months)
  • Body composition at 6 months(6 months)
  • Proximal femur bone mineral density at 6 months(6 months)
  • Low density lipoprotein at 2, 4, and 6 months(6 months)
  • Waist Girth at 6 months(6 months)
  • Trunk fat skinfolds at 6 months(6 months)

研究者

申办方类型
Other

研究点 (2)

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