Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women (VALOBAB-C)
Primary Purpose
Cardiometabolic Risk
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
3g milk polar lipid fortified cheese consumption
5g milk polar lipid fortified cheese consumption
Unfortified cheese product consumption
Sponsored by
About this trial
This is an interventional basic science trial for Cardiometabolic Risk focused on measuring nutrition, milk, polar lipids, cardiometabolic risk
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
Sites / Locations
- Université d'Auvergne-Laboratoire de Nutrition Humaine
- Centre de Recherche en Nutrition Humaine Rhône-Alpes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
3g milk polar lipid fortified cheese product
5 g milk polar lipid fortified cheese product
Unfortified cheese product
Arm Description
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks
Outcomes
Primary Outcome Measures
Total plasma cholesterol
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
Secondary Outcome Measures
Plasma lipids
Plasma lipids will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters (time 60-120-180-240-270-300-360-420-480 minutes)
Plasma glucose and insulin
Plasma glucose and insulin will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours.
Inflammatory markers
Inflammatory markers will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters
Body composition measurement with bioimpedancemetry
Body composition will be measured fasting before and after the four weeks of cheese product intake.
Energy expenditure and substrate oxidation with indirect calorimetry
Energy metabolism will be measured before and after the four weeks of cheese product intake. Fasting and during all the postprandial period (480 minutes)
Intestinal microbiota with molecular approach
Stools will be collected at home before and after the four weeks of cheese product intake.
Full Information
NCT ID
NCT02099032
First Posted
March 25, 2014
Last Updated
January 26, 2021
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02099032
Brief Title
Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
Acronym
VALOBAB-C
Official Title
Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiometabolic Risk
Keywords
nutrition, milk, polar lipids, cardiometabolic risk
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3g milk polar lipid fortified cheese product
Arm Type
Experimental
Arm Description
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
Arm Title
5 g milk polar lipid fortified cheese product
Arm Type
Experimental
Arm Description
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
Arm Title
Unfortified cheese product
Arm Type
Placebo Comparator
Arm Description
Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks
Intervention Type
Other
Intervention Name(s)
3g milk polar lipid fortified cheese consumption
Intervention Description
Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
Intervention Type
Other
Intervention Name(s)
5g milk polar lipid fortified cheese consumption
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Unfortified cheese product consumption
Intervention Description
Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks
Primary Outcome Measure Information:
Title
Total plasma cholesterol
Description
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
Time Frame
Day 0 and Day 28
Secondary Outcome Measure Information:
Title
Plasma lipids
Description
Plasma lipids will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters (time 60-120-180-240-270-300-360-420-480 minutes)
Time Frame
Day 0 and Day 28
Title
Plasma glucose and insulin
Description
Plasma glucose and insulin will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours.
Time Frame
Day 0 and Day 28
Title
Inflammatory markers
Description
Inflammatory markers will be measured before and after the four weeks of cheese product intake. Fasting and postprandial measurements over 8 hours depending on parameters
Time Frame
Day 0 and Day 28
Title
Body composition measurement with bioimpedancemetry
Description
Body composition will be measured fasting before and after the four weeks of cheese product intake.
Time Frame
Day 0 and Day 28
Title
Energy expenditure and substrate oxidation with indirect calorimetry
Description
Energy metabolism will be measured before and after the four weeks of cheese product intake. Fasting and during all the postprandial period (480 minutes)
Time Frame
Day 0 and Day 28
Title
Intestinal microbiota with molecular approach
Description
Stools will be collected at home before and after the four weeks of cheese product intake.
Time Frame
before and after the four weeks of cheese product intake
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Université d'Auvergne-Laboratoire de Nutrition Humaine
City
Clermont-Ferrand
ZIP/Postal Code
63001
Country
France
Facility Name
Centre de Recherche en Nutrition Humaine Rhône-Alpes
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33857018
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.
Results Reference
derived
PubMed Identifier
31189655
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.
Results Reference
derived
Links:
URL
http://www.crnh-rhone-alpes.fr
Description
Related Info
URL
http://www1.clermont.inra.fr/crnh/
Description
Related Info
Learn more about this trial
Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
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