Clinical trial NCT02099032: Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
Official title: Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Risk
Keywords: nutrition
milk
polar lipids
cardiometabolic risk
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 59
Sex: FEMALE
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

The purpose of this research is to study plasma cholesterol variation after daily intake of milk polar lipids-fortified cheese products. The volunteers will have to consume 100 g of cheese product during four weeks instead of their usual cheese products.

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).


Eligibility criteria: Inclusion Criteria:

* Menopausal women
* Of less than 75 years old- Body Mass Index of 25 to 35 kg/m2
* Waist circumference greater than 80 cm
* Normal (or not clinically significant) glycemic and lipid parameters

Exclusion Criteria:

* Dairy products allergy or intolerance
* Smokers (more than five cigarettes/day)
* HDL cholesterol greater than 1.5 mmol/L
* Medication that could interfere with lipid metabolism or intestinal microbiota (for example, no antibiotics within the 2 months before the study)
* Hormone replacement treatment for menopause

Primary outcomes:
measure: Total plasma cholesterol
timeFrame: Day 0 and Day 28
Secondary outcomes:
measure: Plasma lipids
timeFrame: Day 0 and Day 28
measure: Plasma glucose and insulin
timeFrame: Day 0 and Day 28
measure: Inflammatory markers
timeFrame: Day 0 and Day 28
measure: Body composition measurement with bioimpedancemetry
timeFrame: Day 0 and Day 28
measure: Energy expenditure and substrate oxidation with indirect calorimetry
timeFrame: Day 0 and Day 28
measure: Intestinal microbiota with molecular approach
timeFrame: before and after the four weeks of cheese product intake
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Université d'Auvergne-Laboratoire de Nutrition Humaine
city: Pierre-Bénite
country: France
facility: Centre de Recherche en Nutrition Humaine Rhône-Alpes
Study officials:
References:
citation: 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-Brugere 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):e146161. doi: 10.1172/jci.insight.146161.
citation: 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.