Impact of Milk Polar Lipids Content in a Test Meal on Lipid Composition of Ileostomy Fluid and Consequences on Postprandial Dietary Cholesterol and Fatty Acid Metabolism.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 3
- 主要终点
- Ileal sphingomyelin output
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. Milk polar lipids are rich in sphingomyelin and they may have beneficial effects on lipid metabolism in the context of metabolic diseases of nutritional origin.
The purpose of this research is to study the variation of sphingomyelin content at the ileum's end after the consumption of different doses of milk polar lipids, and consequences on the intestinal absorption and metabolism of fatty acids and cholesterol.
The subjects will be taking three different test meals varying by their milk polar lipids content.
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
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 75 years
- •Having undergone a temporary or permanent ileostomy,
- •Considered to have well-functioning ileostomy
- •Normal (or not clinically significant) lipid parameters
排除标准
- •Ileostomy due to an ongoing digestive cancer
- •Ileostomy due to a Chrohn's disease
- •Dairy products allergy or intolerance
- •Medication that could interfere with lipid metabolism
结局指标
主要结局
Ileal sphingomyelin output
时间窗: up to Day 63
The total sphingomyelin output will be measured in the ileostomy fluids over 8 hours after the consumption of the 3 different test meals.
次要结局
- Plasma lipids and isotopic tracers(A least Day 7, Day 35 and Day 63)
- Energy expenditure and substrate oxidation with indirect calorimetry(At least Day7, Day 35 and Day 63)
- Plasma glucose and insulin(At least Day 7, Day 35 and Day 63)