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Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women (VALOBAB-C)

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: NCT02099032
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date  ICMJE March 25, 2014
First Posted Date  ICMJE March 28, 2014
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE March 2014
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
Total plasma cholesterol [ Time Frame: Day 0 and Day 28 ]
Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2014)
  • Plasma lipids [ Time Frame: Day 0 and Day 28 ]
    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 [ Time Frame: Day 0 and Day 28 ]
    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 [ Time Frame: Day 0 and Day 28 ]
    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 [ Time Frame: Day 0 and Day 28 ]
    Body composition will be measured fasting before and after the four weeks of cheese product intake.
  • Energy expenditure and substrate oxidation with indirect calorimetry [ Time Frame: Day 0 and Day 28 ]
    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 [ Time Frame: before and after the four weeks of cheese product intake ]
    Stools will be collected at home before and after the four weeks of cheese product intake.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women
Official Title  ICMJE Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Cardiometabolic Risk
Intervention  ICMJE
  • Other: 3g milk polar lipid fortified cheese consumption
    Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
  • Other: 5g milk polar lipid fortified cheese consumption
    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.
  • Other: Unfortified cheese product consumption
    Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks
Study Arms  ICMJE
  • Experimental: 3g milk polar lipid fortified cheese product
    Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
    Intervention: Other: 3g milk polar lipid fortified cheese consumption
  • Experimental: 5 g milk polar lipid fortified cheese product
    Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks.
    Intervention: Other: 5g milk polar lipid fortified cheese consumption
  • Placebo Comparator: Unfortified cheese product
    Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks
    Intervention: Other: Unfortified cheese product consumption
Publications * 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, Gésan-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-Brugère 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
59
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2014)
78
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02099032
Other Study ID Numbers  ICMJE 2013.821
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor  ICMJE Hospices Civils de Lyon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hospices Civils de Lyon
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP