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

NCT02146339 | Completed

• 1 other identifier: 2013.828
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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).

Conditions

Cardiometabolic Risk

Keywords

nutrition; milk; polar lipids; cardiometabolic risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Plasma lipids and isotopic tracers

  A least Day 7, Day 35 and Day 63

• Plasma glucose and insulin

  At least Day 7, Day 35 and Day 63

• Energy expenditure and substrate oxidation with indirect calorimetry

  At least Day7, Day 35 and Day 63

Study Arms (6)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

OTHER

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

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

EXPERIMENTAL

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

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

OTHER

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

Interventions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

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

Clermont-Ferrand, 63000, France

Location

Centre de Recherche en Nutrition Humaine Rhône-Alpes

Lyon, France

Location

Related Publications (2)

• 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.

  PMID: 33857018 DERIVED

• 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.

  PMID: 31189655 DERIVED

Related Links

• Related Info
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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 27, 2016

Record last verified: 2016-01

Locations

FR (2)