Overweight
Conditions
Keywords
whey protein microgels, thermogenesis
Brief summary
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
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.
Interventions
OTHERControl (WPM 0)
85.0 % maltodextrin,15.0% fat, 0% WPM
OTHERWPM 30
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
OTHERWPM 50
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
OTHERMC 50
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| thermic effect of food | 7 hours from baseline measurements | gas exchanges through indirect calorimetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Whole body protein turnover | 7 hours from baseline | protein synthesis and breakdown |
Outcome results
None listed