Milk Polar Lipids Consumption, Lipid Metabolism, and Inflammation in Menopausal Women

Study Overview
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Brief Summary
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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).

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

Conditions
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Cardiometabolic Risk

Intervention / Treatment
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* Other: 3g milk polar lipid fortified cheese consumption
* Other: 5g milk polar lipid fortified cheese consumption
* Other: Unfortified cheese product consumption


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3g milk polar lipid fortified cheese product<br>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<br>* Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.<br>|
| Experimental: 5 g milk polar lipid fortified cheese product<br>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<br>* 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.<br>|
| Placebo Comparator: Unfortified cheese product<br>Women will have to consume daily 100g of a cheese product instead of usual cheese products during four weeks | Other: Unfortified cheese product consumption<br>* Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total plasma cholesterol | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, milk, polar lipids, cardiometabolic risk