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

Cardiometabolic Risk Clinical Trial

— VALOBAB-C  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02099032
• Other study ID #: 2013.821
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Risk
• Inflammation

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

Locations

Country	Name	City	State
France	Université d'Auvergne-Laboratoire de Nutrition Humaine	Clermont-Ferrand
France	Centre de Recherche en Nutrition Humaine Rhône-Alpes	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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