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

Civil Hospices of Lyon

Status: Completed

Conditions: Cardiometabolic Risk

Treatments: Other: Unfortified cheese product consumption; Other: 3g milk polar lipid fortified cheese consumption; Other: 5g milk polar lipid fortified cheese consumption

Study type: Interventional

Funder types: Other

Identifiers

NCT02099032

2013.821

Details and patient eligibility

About

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).

Enrollment: 59 patients

Sex: Female

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 3 patient groups, including a placebo group

3g milk polar lipid fortified cheese product

Experimental group

Description:

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

Treatment:

Other: 3g milk polar lipid fortified cheese consumption

5 g milk polar lipid fortified cheese product

Experimental group

Description:

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

Treatment:

Other: 5g milk polar lipid fortified cheese consumption

Unfortified cheese product

Placebo Comparator group

Description:

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

Treatment:

Other: Unfortified cheese product consumption