Cardiometabolic Risk Clinical Trial
— VALOBAB-DOfficial 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.
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).
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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 |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
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 |
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