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

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

Tracking Information

• First Submitted Date: March 25, 2014
• First Posted Date: March 28, 2014
• Last Update Posted Date: January 27, 2021
• Study Start Date: March 2014
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Basic Science
• Condition: Cardiometabolic Risk

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 26, 2016): 59
• Original Estimated Enrollment (submitted: March 25, 2014): 78
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: up to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02099032
• Other Study ID Numbers: 2013.821
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Hospices Civils de Lyon
• Study Sponsor: Hospices Civils de Lyon
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospices Civils de Lyon
• Verification Date: January 2021