Whey Protein Micelles and Thermogenesis in Overweight Subjects
Whey Protein Micelles and Thermogenesis in Overweight Subjects
The main objective of the trial is to measure the thermogenic effect of two different doses
 of whey protein microgels.

 It will be a randomized crossover double-blind design conducted in 20 subjects.
Primary objective and outcome:

 The primary objective of the trial is to measure the thermogenic effect of two different
 doses of whey protein microgels (WPM).

 Secondary objectives and outcomes:

 Explore the mechanism of action of WPM on thermogenesis including:

 Protein turnover in response to the dose and the source of protein (WPM versus casein)
 Insulinemic and glycemic response to the dose and source of protein (WPM versus casein)

 Design: The proposed study is a randomized double-blind, placebo-controlled, single center,
 crossover design.

 At the start of the study, subjects will be randomly assigned to 4 different groups in a
 crossover design, where they will be asked to consume a beverage containing Product 1: 0g of
 protein (maltodextrin control) Product 2: 30g of WPM Product 3: 50g of WPM Product 4: 50g of
 micellar casein (MC) Number of subjects: The number of subjects will be 15. Sufficient
 subjects should be recruited to provide a 30% drop-out rate. Therefore 20 subjects will be
 needed including drop-outs.
Inclusion Criteria:

 Overweight (BMI range between 25.0 and 29.9 kg per m2 Healthy Having obtained his/her
 subjects over 20 year informed consent.

 Exclusion Criteria:

 Chronic or acute diseases affecting protein metabolism (diabetes, renal insufficiency, CVD,
 liver disease), dyslipidemia History of varicose or venous stases Recent major surgery (3
 months) History of major gastro-intestinal surgery (gastric bypass, intestinal resection
 etc…) Malabsorption disorders History of cancer within the past year Significant weight
 loss during the last 3 months Food allergies, especially cow milk protein. Pregnancy or
 lactation Special diets especially vegetarian, high protein (≥ 1.6 g/kg) or weight loss
 program Abnormal Food Frequency Questionnaire Aversion to vanilla or chocolate aromas
 Smoking Moderate to intense physical activity > 2 hours/week Hematocrit <40 for males and <
 36 for females Blood donation within 3 months of study start and 3 months after study end
 Regular consumption of medication and supplements i.e. any treatment affecting
 thermogenesis or nutrient metabolism in general such as corticosteroids, insulin,
 androgens, antibiotics and nutritional supplements (multivitamins, protein shakes).

 Have a high alcohol consumption (more than 1 drink/day) Consumption of illicit drugs
 Subject who cannot be expected to comply with the study procedures, including consuming the
 test products.

 Currently participating or having participated in another clinical trial during the last 4
 weeks prior to the beginning of this study.