Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Total plasma cholesterol
研究概览
简要总结
Polar lipids have a specific chemical structure: they are an essential component of human cell membranes, play a major role in the nervous system and also influence the metabolic pathways including the cholesterol metabolism.
Polar lipids are used in food-processing industry for their emulsification properties. The most famous emulsifier is soya lecithin but milk also naturally contains natural emulsifiers such as polar lipids.
The purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.
It is a bi-centric study with a centre in LYON (Centre de Recherche en Nutrition Humaine Rhône-Alpes) and CLERMONT-FERRAND (Centre de Recherche en Nutrition Humaine Auvergne).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal women
- •Of less than 75 years old- Body Mass Index of 25 to 35 kg/m2
- •Waist circumference greater than 80 cm
- •Normal (or not clinically significant) glycemic and lipid parameters
排除标准
- •Dairy products allergy or intolerance
- •Smokers (more than five cigarettes/day)
- •HDL cholesterol greater than 1.5 mmol/L
- •Medication that could interfere with lipid metabolism or intestinal microbiota (for example, no antibiotics within the 2 months before the study)
- •Hormone replacement treatment for menopause
研究组 & 干预措施
3g milk polar lipid fortified cheese product
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
干预措施: 3g milk polar lipid fortified cheese consumption (Other)
5 g milk polar lipid fortified cheese product
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
干预措施: 5g milk polar lipid fortified cheese consumption (Other)
Unfortified cheese product
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks
干预措施: Unfortified cheese product consumption (Other)
结局指标
主要结局
Total plasma cholesterol
时间窗: Day 0 and Day 28
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
次要结局
- Body composition measurement with bioimpedancemetry(Day 0 and Day 28)
- Energy expenditure and substrate oxidation with indirect calorimetry(Day 0 and Day 28)
- Plasma lipids(Day 0 and Day 28)
- Plasma glucose and insulin(Day 0 and Day 28)
- Intestinal microbiota with molecular approach(before and after the four weeks of cheese product intake)
- Inflammatory markers(Day 0 and Day 28)