Dairy Lipids and Cardiometabolic Risk
ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospices Civils de Lyon
About this trial
It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group).
Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women between 18-70 years
Body Mass Index (BMI) between 35 and 60 kg/m2 inclusive
Stable body weight (weight change +/- 5 % for 3 months prior to screening)
Consumption of at least 1 serving/day of dairy products made from cow's milk
Disqualifiers
History of bariatric or digestive surgery or disease interfering with main outcomes
Drinking more than 3 glasses of alcohol per day (>30g/day)
Pregnancy, parturiency or breastfeeding
Food allergies or intolerance to dairy products
Trial design
Design model
Parallel
Treatments tested in this trial
Low-fat dairy products
Other intervention3-month intervention
Whole-fat dairy products
Other intervention3-month intervention
Milk polar lipid enriched whole-fat dairy products
Other intervention3-month intervention
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Low-fat dairy products within a dietary handling for weight lossOther 1 intervention
Group B: Whole-fat dairy products within a dietary handling for weight lossExperimental treatment 1 intervention
Group C: Whole-fat dairy products enriched with milk polar lipids within a dietary handling for weight lossExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Total plasma apolipoprotein B concentration
Change in fasting total plasma apolipoprotein B concentration after 3-month intervention, measured by ELISA.
Time frame
day 0 and day 90Secondary outcomes
1
Changes in weight
Changes in weight after 3-month intervention.
Time frame
day 0 and day 902
Anthropometric measurements 2
Changes in waist and hip circumferences after 3-month intervention.
Time frame
day 0 and day 903
Body mass composition measurements
Change in body mass composition (lean mass, fat mass) after 3-month intervention, analyzed by impedancemeter
Time frame
day 0 and day 904
Plasma lipid concentrations after 3-month intervention, measured using standard laboratory methods
Changes in plasma concentrations of triglycerides
Time frame
day 0 and day 90 for fasting and postprandial measurements. • For postprandial measurements: times 60 minutes-120 minutes -180 minutes -240 minutes -270 minutes -300 minutes -360 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospices Civils de Lyon
Lead sponsor
Laboratoire de Recherche en Cardiovasculaire, Métabolisme, Diabétologie et Nutrition
Collaborator
Centre de Recherche en Nutrition Humaine Rhone-Alpe
Collaborator
Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Collaborator
Source ClinicalTrials.gov