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

Cardiometabolic Risk Clinical Trial

— VALOBAB-D  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146339
• Other study ID #: 2013.828
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: January 26, 2016
• Start date: April 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cardiometabolic Risk

Intervention

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
• 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
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
France	Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle	Clermont-ferrand
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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