VALOBAB-D: Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Ileal sphingomyelin output [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.
Secondary Outcome Measures
- Plasma lipids and isotopic tracers [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.
- Plasma glucose and insulin [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.
- Energy expenditure and substrate oxidation with indirect calorimetry [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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women aged between 18 and 75 years
-
Having undergone a temporary or permanent ileostomy,
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Considered to have well-functioning ileostomy
-
Normal (or not clinically significant) lipid parameters
Exclusion Criteria:
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Ileostomy due to an ongoing digestive cancer
-
Ileostomy due to a Chrohn's disease
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Dairy products allergy or intolerance
-
Medication that could interfere with lipid metabolism
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle | Clermont-ferrand | France | 63000 | |
| 2 | Centre de Recherche en Nutrition Humaine Rhône-Alpes | Lyon | France |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2013.828