Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism (VALOBAB-D)

Civil Hospices of Lyon

Status: Completed

Conditions: Cardiometabolic Risk

Treatments: Other: Cheese n°3 - cheese n°1- cheese n°2; Other: Cheese n°3- cheese n°2 - cheese n°1; Other: Cheese n°1- cheese n°2 - cheese n°3; Other: cheese n°2 - cheese n°1- cheese n°3; Other: Cheese n°1- cheese n°3 - cheese n°2; Other: Cheese n°2- cheese n°3 - cheese n°1

Study type: Interventional

Funder types: Other

Identifiers

NCT02146339

2013.828

Details and patient eligibility

About

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).

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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4 participants in 6 patient groups

Unfortified-3g-5g milk polar lipid fortified cheese product

Experimental group

Description:

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.

Treatment:

Other: Cheese n°1- cheese n°2 - cheese n°3

Unfortified-5g-3g milk polar lipid fortified cheese product

Experimental group

Description:

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.

Treatment:

Other: Cheese n°1- cheese n°3 - cheese n°2

3g-5g milk polar lipid fortified-unfortified cheese product

Experimental group

Description:

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.

Treatment:

Other: Cheese n°2- cheese n°3 - cheese n°1

3g-Unfortified-5g milk polar lipid fortified cheese product

Other group

Description:

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

Treatment:

Other: cheese n°2 - cheese n°1- cheese n°3

5g-unfortified-3g milk polar lipid fortified cheese product

Experimental group

Description:

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.

Treatment:

Other: Cheese n°3 - cheese n°1- cheese n°2

5g-3g milk polar lipid fortified-unfortified cheese product

Other group

Description:

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.

Treatment:

Other: Cheese n°3- cheese n°2 - cheese n°1