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

January 26, 2021 updated by: Hospices Civils de Lyon

Influence of Milk Polar Lipids Intake on Lipid Metabolism, Body Composition, Inflammation and Intestinal Microbiota in Menopausal Women

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63001
        • Université d'Auvergne-Laboratoire de Nutrition Humaine
      • Pierre-Bénite, France, 69310
        • Centre de recherche en nutrition humaine Rhone-Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 and Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 0 and Day 28
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.
Day 0 and Day 28
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
Day 0 and Day 28
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.
Day 0 and Day 28
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)
Day 0 and Day 28
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.
before and after the four weeks of cheese product intake

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 25, 2014

First Submitted That Met QC Criteria

March 25, 2014

First Posted (Estimate)

March 28, 2014

Study Record Updates

Last Update Posted (Actual)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013.821

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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