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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-01-31

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).

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Detailed Description

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Conditions

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Cardiometabolic Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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3g milk polar lipid fortified cheese product

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

Group Type EXPERIMENTAL

3g milk polar lipid fortified cheese consumption

Intervention Type 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.

5 g milk polar lipid fortified cheese product

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

Group Type EXPERIMENTAL

5g milk polar lipid fortified cheese consumption

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Unfortified cheese product consumption

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type OTHER

Unfortified cheese product consumption

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

Intervention Type OTHER

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

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No