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Impact of Milk Polar Lipids on Lipids Digestion, Absorption and Metabolism (VALOBAB-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02146339
Recruitment Status : Completed
First Posted : May 23, 2014
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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
Cardiometabolic Risk Other: Cheese n°1- cheese n°2 - cheese n°3 Other: Cheese n°1- cheese n°3 - cheese n°2 Other: cheese n°2 - cheese n°1- cheese n°3 Other: Cheese n°2- cheese n°3 - cheese n°1 Other: Cheese n°3 - cheese n°1- cheese n°2 Other: Cheese n°3- cheese n°2 - cheese n°1 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.
Study Start Date : April 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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


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


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





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146339


Locations
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France
Centre de recherche en Nutrition Humaine-Auvergne -Unité d'Exploration Nutritionnelle
Clermont-ferrand, France, 63000
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Lyon, France
Sponsors and Collaborators
Hospices Civils de Lyon
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02146339    
Other Study ID Numbers: 2013.828
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Hospices Civils de Lyon:
nutrition
milk
polar lipids
cardiometabolic risk