- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02146339
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
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Clermont-ferrand, France, 63000
- Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle
-
Lyon, France
- Centre de Recherche en Nutrition Humaine Rhône-Alpes
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
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.
|
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 |
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.
|
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.
|
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
Time Frame: 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.
|
up to Day 63
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma lipids and isotopic tracers
Time Frame: 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.
|
A least Day 7, Day 35 and Day 63
|
Plasma glucose and insulin
Time Frame: 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.
|
At least Day 7, Day 35 and Day 63
|
Energy expenditure and substrate oxidation with indirect calorimetry
Time Frame: 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).
|
At least Day7, Day 35 and Day 63
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2013.828
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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