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

Hospices Civils de Lyon4 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Cardiometabolic Risk

Interventions

Cheese n°1- cheese n°2 - cheese n°3OTHER

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

Cheese n°1- cheese n°3 - cheese n°2OTHER

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

cheese n°2 - cheese n°1- cheese n°3OTHER

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

Cheese n°2- cheese n°3 - cheese n°1OTHER

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

Cheese n°3 - cheese n°1- cheese n°2OTHER

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

Cheese n°3- cheese n°2 - cheese n°1OTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle

Clermont-Ferrand, France

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Lyon, France

Outcomes

Primary Outcomes

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.

Time frame: up to Day 63

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: At least Day7, Day 35 and Day 63