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Completed

NCT Number: NCT02099032

Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation 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).

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Key information

Conditions

Cardiometabolic Risk

Age range

Up to 75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Université d'Auvergne-Laboratoire de Nutrition Humaine, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3g milk polar lipid fortified cheese consumption

Other

Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.

5g milk polar lipid fortified cheese consumption

Other

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.

Unfortified cheese product consumption

Other

Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: VALOBAB-C

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2014
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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