Whey Protein Micelles and Thermogenesis in Overweight Subjects

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Whey Protein Micelles and Thermogenesis In Overweight Subjects

Conditions
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Overweight

Intervention / Treatment
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* Other: Control (WPM 0)
* Other: WPM 30
* Other: WPM 50
* Other: MC 50


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control (WPM 0)<br>400 mL beverage with 85.0% maltodextrine, 15.0% fat and 0% of whey protein micelles Product given once after 1 hour of monitoring for baseline | Other: WPM 30<br>* 43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM<br>Other: WPM 50<br>* 16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM<br>Other: MC 50<br>* 16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC<br>|
| Active Comparator: WPM 30<br>400 mL beverage with 43.7% of maltodextrine, 15.2 % fat and 41.1% (30 g) of whey protein micelles Product given once after 1 hour of monitoring for baseline | Other: Control (WPM 0)<br>* 85.0 % maltodextrin,15.0% fat, 0% WPM<br>Other: WPM 50<br>* 16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM<br>Other: MC 50<br>* 16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC<br>|
| Active Comparator: WPM 50<br>400 mL beverage with 16.3% of maltodextrine, 15.2 % fat and 68.5% (50 g) of whey protein micelles Product given once after 1 hour of monitoring for baseline | Other: Control (WPM 0)<br>* 85.0 % maltodextrin,15.0% fat, 0% WPM<br>Other: WPM 30<br>* 43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM<br>Other: MC 50<br>* 16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC<br>|
| Active Comparator: MC 50<br>400 mL beverage with 16.7% of maltodextrine, 15.0 % fat and 68.2% (50 g) of whey protein micelles 50 g of micellar casein Product given once after 1 hour of monitoring for baseline | Other: Control (WPM 0)<br>* 85.0 % maltodextrin,15.0% fat, 0% WPM<br>Other: WPM 30<br>* 43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM<br>Other: WPM 50<br>* 16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| thermic effect of food | gas exchanges through indirect calorimetry | 7 hours from baseline measurements | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole body protein turnover | protein synthesis and breakdown | 7 hours from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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whey protein microgels, thermogenesis