Clinical trial NCT02303080: Whey Protein Micelles and Thermogenesis in Overweight Subjects
Official title: Whey Protein Micelles and Thermogenesis In Overweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: whey protein microgels
thermogenesis
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 17
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: thermic effect of food
timeFrame: 7 hours from baseline measurements
Secondary outcomes:
measure: Whole body protein turnover
timeFrame: 7 hours from baseline
Other outcomes:
Locations:
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Maurice Beaumont, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kassis A, Godin JP, Moille SE, Nielsen-Moennoz C, Groulx K, Oguey-Araymon S, Praplan F, Beaumont M, Sauser J, Monnard I, Kapp AF, Ammon-Zufferey C, Frei N, Guignard L, Delodder F, Mace K. Effects of protein quantity and type on diet induced thermogenesis in overweight adults: A randomized controlled trial. Clin Nutr. 2019 Aug;38(4):1570-1580. doi: 10.1016/j.clnu.2018.08.004. Epub 2018 Aug 10.