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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 : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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).


Condition or disease Intervention/treatment Phase
Cardiometabolic Risk Other: 3g milk polar lipid fortified cheese consumption Other: 5g milk polar lipid fortified cheese consumption Other: Unfortified cheese product consumption Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women
Study Start Date : March 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Arm Intervention/treatment
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.
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.

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.
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.

Placebo Comparator: Unfortified cheese product
Women will have to consume daily 100g of a 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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

  4. 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.

  5. 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)

  6. 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.



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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02099032


Locations
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France
Université d'Auvergne-Laboratoire de Nutrition Humaine
Clermont-Ferrand, France, 63001
Centre de Recherche en Nutrition Humaine Rhône-Alpes
Pierre-Bénite (Lyon), France
Sponsors and Collaborators
Hospices Civils de Lyon
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02099032    
Other Study ID Numbers: 2013.821
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: January 2016
Keywords provided by Hospices Civils de Lyon:
nutrition
milk
polar lipids
cardiometabolic risk
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes