A 4-week Study in Children and Adolescents With Familial or Severe Hypercholesterolemia Comparing Flaxseed Therapy to Placebo
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
- 否
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
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
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
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children
