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临床试验/NCT01007344
NCT01007344已完成3 期

A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年10月最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
2
主要终点
fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein

研究概览

简要总结

The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4 weeks could potentially reduce the serum lipid levels in children and adolescents with familial or severe hypercholesterolemia compared to those on placebo.

详细描述

The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial. Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for Sick Children, which provides consultations to and management of children with primary lipid abnormalities. Patients that meet the study criteria will be approached during their routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will randomly be assigned to the intervention or the placebo group. The intervention group will be given muffins and breads containing ground flaxseed. Two muffins and one slice of bread will be consumed per day to provide a total of 30g flaxseed to the experimental group. The control group will be given muffins and breads containing whole wheat flour in place of flaxseed. Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins and breads use in the study will be baked by an independent baker.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • age 8 to 18 years
  • positive first-degree family history of hypercholesterolemia or premature atherosclerotic cardiovascular disease
  • elevated LDL level above 3.5 mmol/L and less than 5.0 mmol/L
  • entered in the National Cholesterol Education Program Step II diet for at least 6 months

排除标准

  • patients with secondary causes of hyperlipidemia
  • history of major illness or surgery 3 months or less prior to enrollment
  • taking lipid-lowering medications
  • history of gastrointestinal problems
  • allergies towards flaxseed

研究组 & 干预措施

flaxseed

Active Comparator

2 muffins and 1 slice of bread for a total of 30g flaxseed per day

干预措施: flaxseed (Dietary Supplement)

whole wheat flour

Placebo Comparator

2 muffins and 1 slice of bread containing whole wheat flour per day

干预措施: whole wheat flour (Dietary Supplement)

结局指标

主要结局

fasting serum total cholesterol, triglycerides, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) and C-reactive protein

时间窗: 4 weeks

次要结局

  • LH (luteinizing hormone, FSH (follicle-stimulating hormone), DHEA-S (Dihydroepiandrosterone sulfate), free testosterone, androstenedione(4 weeks)
  • complete blood count(4 weeks)

研究者

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

Brian McCrindle

Staff Cardiologist

The Hospital for Sick Children

研究点 (2)

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