Clinical trial NCT02146339: Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk
Keywords: nutrition
milk
polar lipids
cardiometabolic risk
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Ileal sphingomyelin output
timeFrame: up to Day 63
Secondary outcomes:
measure: Plasma lipids and isotopic tracers
timeFrame: A least Day 7, Day 35 and Day 63
measure: Plasma glucose and insulin
timeFrame: At least Day 7, Day 35 and Day 63
measure: Energy expenditure and substrate oxidation with indirect calorimetry
timeFrame: At least Day7, Day 35 and Day 63
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle
city: Lyon
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study officials:
References:
citation: 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-Brugere 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):e146161. doi: 10.1172/jci.insight.146161.
citation: 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.