Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Cardiometabolic Risk

Intervention / Treatment
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* Other: Cheese n°1- cheese n°2 - cheese n°3
* Other: Cheese n°1- cheese n°3 - cheese n°2
* Other: cheese n°2 - cheese n°1- cheese n°3
* Other: Cheese n°2- cheese n°3 - cheese n°1
* Other: Cheese n°3 - cheese n°1- cheese n°2
* Other: Cheese n°3- cheese n°2 - cheese n°1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unfortified-3g-5g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°1- cheese n°2 - cheese n°3<br>* 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<br>|
| Experimental: Unfortified-5g-3g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°1- cheese n°3 - cheese n°2<br>* 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<br>|
| Experimental: 3g-5g milk polar lipid fortified-unfortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°2- cheese n°3 - cheese n°1<br>* 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<br>|
| Other: 3g-Unfortified-5g milk polar lipid fortified cheese product<br>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 | Other: cheese n°2 - cheese n°1- cheese n°3<br>* 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<br>|
| Experimental: 5g-unfortified-3g milk polar lipid fortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°3 - cheese n°1- cheese n°2<br>* 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<br>|
| Other: 5g-3g milk polar lipid fortified-unfortified cheese product<br>Each subject will receive a single dose of each cheese product (100 g) containing no or 3g or 5g of milk polar lipids, 300 mg of [1,1,1]-13C-triolein and 45 mg of 2H6-cholesterol. The wash-out period is four weeks. | Other: Cheese n°3- cheese n°2 - cheese n°1<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ileal sphingomyelin output | The total sphingomyelin output will be measured in the ileostomy fluids over 8 hours after the consumption of the 3 different test meals. | up to Day 63 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lipids and isotopic tracers | 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. | A least Day 7, Day 35 and Day 63 | 
| Plasma glucose and insulin | Plasma glucose and insulin will be measured after the consumption of the 3 different test meals. Fasting and postprandial measurements over 8 hours. | At least Day 7, Day 35 and Day 63 | 
| Energy expenditure and substrate oxidation with indirect calorimetry | 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). | At least Day7, Day 35 and Day 63 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, milk, polar lipids, cardiometabolic risk