Whey Protein Micelles and Thermogenesis in Overweight Subjects

Overweight Clinical Trial

— Thermowhey  

Official title:

Whey Protein Micelles and Thermogenesis In Overweight Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303080
• Other study ID #: 10.19.MET
• Status: Completed
• Phase: N/A
• First received: November 10, 2014
• Last updated: November 25, 2014
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Control (WPM 0)
85.0 % maltodextrin,15.0% fat, 0% WPM
• WPM 30
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
• WPM 50
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
• MC 50
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	thermic effect of food	gas exchanges through indirect calorimetry	7 hours from baseline measurements	No
Secondary	Whole body protein turnover	protein synthesis and breakdown	7 hours from baseline	No