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

Not Applicable

Completed

• Conditions: Cardiometabolic Risk
• Interventions: Other: Cheese n°2- cheese n°3 - cheese n°1; Other: Cheese n°1- cheese n°2 - cheese n°3; Other: Cheese n°1- cheese n°3 - cheese n°2; Other: Cheese n°3 - cheese n°1- cheese n°2; Other: Cheese n°3- cheese n°2 - cheese n°1; Other: cheese n°2 - cheese n°1- cheese n°3

• Registration Number: NCT02146339
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-22
• Study First Posted: 2014-05-23
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
3g-5g milk polar lipid fortified-unfortified cheese product	Cheese n°2- cheese n°3 - cheese n°1	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.
Unfortified-3g-5g milk polar lipid fortified cheese product	Cheese n°1- cheese n°2 - cheese n°3	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.
Unfortified-5g-3g milk polar lipid fortified cheese product	Cheese n°1- cheese n°3 - cheese n°2	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.
5g-unfortified-3g milk polar lipid fortified cheese product	Cheese n°3 - cheese n°1- cheese n°2	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.
5g-3g milk polar lipid fortified-unfortified cheese product	Cheese n°3- cheese n°2 - cheese n°1	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.
3g-Unfortified-5g milk polar lipid fortified cheese product	cheese n°2 - cheese n°1- 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).
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.

Trial Locations

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