Cardiometabolic Risk
Conditions
Keywords
nutrition, milk, polar lipids, cardiometabolic risk
Brief 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).
Interventions
OTHER3g 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.
OTHER5g 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.
OTHERUnfortified cheese product consumption
Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total plasma cholesterol | Day 0 and Day 28 | Total plasma cholesterol will be measured fasting before and after the four weeks of cheese product intake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose and insulin | 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. |
| Inflammatory markers | 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 |
| Plasma lipids | 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) |
| Energy expenditure and substrate oxidation with indirect calorimetry | 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) |
| Intestinal microbiota with molecular approach | 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. |
| Body composition measurement with bioimpedancemetry | Day 0 and Day 28 | Body composition will be measured fasting before and after the four weeks of cheese product intake. |
Countries
France
Outcome results
None listed