Cardiometabolic Risk
Conditions
Keywords
nutrition, milk, polar lipids, cardiometabolic risk
Brief summary
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).
Interventions
OTHERCheese n°1- cheese n°2 - cheese n°3
Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
OTHERCheese n°1- cheese n°3 - cheese n°2
Each subject will receive a single dose of cheese n°1, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
OTHERcheese n°2 - cheese n°1- cheese n°3
Each subject will receive a single dose of cheese n°2, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
OTHERCheese n°2- cheese n°3 - cheese n°1
Each subject will receive a single dose of cheese n°2, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
OTHERCheese n°3 - cheese n°1- cheese n°2
Each subject will receive a single dose of cheese n°3, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
OTHERCheese n°3- cheese n°2 - cheese n°1
Each subject will receive a single dose of cheese n°3, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks. Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ileal sphingomyelin output | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma lipids and isotopic tracers | A least Day 7, Day 35 and Day 63 | Plasma lipids and isotopic tracers will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours depending on parameters. |
| Plasma glucose and insulin | At least Day 7, Day 35 and Day 63 | Plasma glucose and insulin will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours. |
| Energy expenditure and substrate oxidation with indirect calorimetry | At least Day7, Day 35 and Day 63 | Energy metabolism and 13CO2 will be measured after the consumption of the 3 different test meals. Fasting and during all the postprandial period (8 h). |
Countries
France
Outcome results
None listed