NCT01821131进行中（未招募）不适用
A Dose Response, Randomized, Controlled, Double-blind, Cross-over Trial to Determine the LDL Cholesterol Lowering Effect of Ground Flaxseed in Adults With Above Optimal Plasma LDL Concentrations
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- lipid profile
研究概览
简要总结
This Clinical Trial is being conducted to study the LDL (bad) cholesterol lowering abilities of flax. The purpose of this study is to find the lowest dose of flax that can lower LDL-cholesterol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male and non-pregnant/non-lactating female
- •Body mass index 18.5-40.0 kg/m2
- •Fasting plasma LDL cholesterol 2.6-5.0 mmol/L
- •Regular dietary habits (ie. breakfast, lunch and dinner meals consumed daily)
- •Willing to comply with protocol requirements
- •Willing to provide informed consent
排除标准
- •Medical history of cardiovascular disease, use of cholesterol-lowering or blood pressure-lowering medications
- •Fasting plasma triglycerides ≥ 4.0 mmol/L
- •Medical history of diabetes mellitus, fasting plasma glucose ≥ 7.0 mmol/L or use of insulin or oral medication to control blood sugar
- •Medical history of gastrointestinal disease, daily use of any stomach acid-lowering medications or laxatives (including fibre supplements) within the past month or antibiotic use within the past 6 weeks
- •Medical history of inflammatory disease (ie. Systemic lupus erythematosis, rheumatoid arthritis, psoriasis)
- •Medical history of liver disease or liver dysfunction (defined as plasma AST or ALT ≥ 1.5 times the upper limit of normal (ULN))
- •Medical history of kidney disease or kidney dysfunction (defined as blood urea nitrogen and creatinine ≥ 1.8 times the ULN)
- •Active treatment for any type of cancer within 1 year prior to study start
- •Major surgery within the last 3 months
- •Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
- •Unstable body weight (defined as > 5% change in 3 months) or actively participating in a weight loss program
- •Tobacco and/or nicotine replacement use, current or within the last 3 months
- •Taking medication (prescription or non-prescription) or dietary supplements (pre/probiotics, vitamins, minerals, fats, herbals) known to affect blood lipids, with the exception of stable doses of thyroxine and oral contraceptive agents
- •Any food allergy, aversion or unwillingness to eat wheat or flax
- •Daily consumption of flax containing products in the past month
- •Regular intake of > 2 alcoholic drinks per day. Standard drink (13.6 g alcohol)= Beer (5% alcohol) 360 mL (12 fl.oz); Spirits (40% alcohol) 45 mL (1.5 fl.oz); wine (12% alcohol) 150 mL (5 fl.oz)
- •Participation in another clinical trial, current or in the past 4 weeks
研究组 & 干预措施
30g ground flaxseed per day
Experimental
consume 1 muffin containing 30g ground flaxseed every day for 4 weeks
干预措施: muffin (Other)
20g ground flaxseed per day
Experimental
consume 1 muffin containing 20g ground flaxseed every day for 4 weeks
干预措施: muffin (Other)
0g ground flaxseed per day
Placebo Comparator
consume 1 muffin containing 0g ground flaxseed every day for 4 weeks
干预措施: muffin (Other)
结局指标
主要结局
lipid profile
时间窗: 4 weeks
plasma total cholesterol, HDL, LDL and triglycerides
次要结局
- flax metabolites(4 weeks)
- glucose(4 weeks)
- blood pressure(4 weeks)
- high sensitivity c-reactive protein (hsCRP)(4 weeks)
研究者
Dr. Heather Blewett
Principal Investigator
St. Boniface Hospital
研究点 (2)
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