Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
VALOBAB-C
Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
1 other identifier
interventional
59
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 25, 2014
CompletedFirst Posted
Study publicly available on registry
March 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 27, 2021
January 1, 2021
1.8 years
March 25, 2014
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total plasma cholesterol
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
Day 0 and Day 28
Secondary Outcomes (6)
Plasma lipids
Day 0 and Day 28
Plasma glucose and insulin
Day 0 and Day 28
Inflammatory markers
Day 0 and Day 28
Body composition measurement with bioimpedancemetry
Day 0 and Day 28
Energy expenditure and substrate oxidation with indirect calorimetry
Day 0 and Day 28
- +1 more secondary outcomes
Study Arms (3)
3g milk polar lipid fortified cheese product
EXPERIMENTALWomen will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
5 g milk polar lipid fortified cheese product
EXPERIMENTALWomen will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
Unfortified cheese product
PLACEBO COMPARATORWomen will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks
Interventions
Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
Women will have to consume daily 100g of a 5 g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Université d'Auvergne-Laboratoire de Nutrition Humaine
Clermont-Ferrand, 63001, France
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite, 69310, France
Related Publications (2)
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.
PMID: 33857018DERIVEDVors 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.
PMID: 31189655DERIVED
Related Links
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2014
First Posted
March 28, 2014
Study Start
March 1, 2014
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
January 27, 2021
Record last verified: 2021-01