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

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.

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 Overview

• Status: Completed
• Conditions: Cardiometabolic Risk
• Intervention / Treatment: 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°3 - cheese n°1; Other: cheese n°2 - cheese n°1- cheese n°3; Other: Cheese n°3 - cheese n°1- cheese n°2; Other: Cheese n°3- cheese n°2 - cheese n°1

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-ferrand, France, 63000
    • Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle
  • Lyon, France
    • Centre de recherche en nutrition humaine Rhone-Alpes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unfortified-3g-5g milk polar lipid fortified cheese product; 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; 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
Experimental: Unfortified-5g-3g milk polar lipid fortified cheese product; 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; 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
Experimental: 3g-5g milk polar lipid fortified-unfortified cheese product; 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; 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
Other: 3g-Unfortified-5g milk polar lipid fortified cheese product; 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; 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
Experimental: 5g-unfortified-3g milk polar lipid fortified cheese product; 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; 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
Other: 5g-3g milk polar lipid fortified-unfortified cheese product; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• Le Barz M, Vors C, Combe E, Joumard-Cubizolles L, Lecomte M, Joffre F, Trauchessec M, Pesenti S, Loizon E, Breyton AE, Meugnier E, Bertrand K, Drai J, Robert C, Durand A, Cuerq C, Gaborit P, Leconte N, Bernalier-Donadille A, Cotte E, Laville M, Lambert-Porcheron S, Ouchchane L, Vidal H, Malpuech-Brugère C, Cheillan D, Michalski MC. Milk polar lipids favorably alter circulating and intestinal ceramide and sphingomyelin species in postmenopausal women. JCI Insight. 2021 May 24;6(10). pii: 146161. doi: 10.1172/jci.insight.146161.
• Vors C, Joumard-Cubizolles L, Lecomte M, Combe E, Ouchchane L, Drai J, Raynal K, Joffre F, Meiller L, Le Barz M, Gaborit P, Caille A, Sothier M, Domingues-Faria C, Blot A, Wauquier A, Blond E, Sauvinet V, Gesan-Guiziou G, Bodin JP, Moulin P, Cheillan D, Vidal H, Morio B, Cotte E, Morel-Laporte F, Laville M, Bernalier-Donadille A, Lambert-Porcheron S, Malpuech-Brugere C, Michalski MC. Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay. Gut. 2020 Mar;69(3):487-501. doi: 10.1136/gutjnl-2018-318155. Epub 2019 Jun 12.

Helpful Links

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Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 23, 2014

Study Record Updates

• Last Update Posted (Estimate): January 27, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: nutrition; milk; polar lipids; cardiometabolic risk
• Other Study ID Numbers: 2013.828

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No