Rationale, Study Design and Baseline Data of the TRANSQUAL Clinical Trial: A Study to Evaluate the Impact of Different Milk Fatty Acid Profiles on Cardiovascular Risk Factors in Healthy Volunteers; Focus on Trans Fatty Acids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- HDL-cholesterol
研究概览
简要总结
The investigators' project has for principal objective to evaluate the impact of three specific ruminant milk fats with a Trans Fatty Acid content ranging from 2.9% to 12.2% obtained by modification of the cow's diet on cardiovascular risk factors in healthy subjects.
详细描述
111 healthy, normolipemic men and women (18y to 50y) have been recruited for a monocentric, randomised, double-blind, controlled 4-week study. All the volunteers consumed 3 experimental products (butter, dessert cream and cakes) made with one of the 3 specific milk fats up to 55 g fat/day.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HDL cholesterol, g/L > 0.4
- •Triacylglycerol g/L <1.50
- •LDL Cholesterol g/L <1.60
- •Waist size < 94 cm (men) or 80 cm (women)
- •Affiliated to National Health Insurance
- •Normal blood pressure (diastolic <90 mm Hg, systolic <140 mm Hg)
- •For women: effective contraception
- •Subject giving his/her written informed consent
- •Subject willing to comply with the study procedures
排除标准
- •Reported food allergies
- •Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
- •Hepatic or renal impairments
- •Positive serologies to HIV or HCV,
- •Blood donation done less than 2 months before the start of the study
- •Chronic pathologies
- •Refusal to be registered on the National Volunteers Data file
- •Being in exclusion on the National Volunteers Data file
研究组 & 干预措施
A
Arms A: the lowest R-TFA/SFA ratio obtained from dairy cows in Winter period
干预措施: Ruminant trans fatty acid enriched diet - lowest ratio (Dietary Supplement)
B
Arms B: the medium R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 4.1% flax seed.
干预措施: Ruminant trans fatty acid enriched diet - medium ratio (Dietary Supplement)
C
Arms C: the highest R-TFA/SFA ratio obtained from dairy cows feeding with Winter diet supplemented with 9% flax seed.
干预措施: Ruminant trans fatty acid enriched diet - highest ratio (Dietary Supplement)
结局指标
主要结局
HDL-cholesterol
次要结局
- total cholesterol
- LDL-cholesterol
- triglycerides
- apolipoprotein