Whey Protein Micelles and Thermogenesis in Overweight Subjects (Thermowhey)

November 25, 2014 updated by: Société des Produits Nestlé (SPN)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control (WPM 0)
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
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
Other: WPM 50
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
Other: MC 50
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
Active Comparator: WPM 30
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: WPM 50
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
Other: MC 50
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
Other: Control (WPM 0)
85.0 % maltodextrin,15.0% fat, 0% WPM
Active Comparator: WPM 50
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: WPM 30
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
Other: MC 50
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
Other: Control (WPM 0)
85.0 % maltodextrin,15.0% fat, 0% WPM
Active Comparator: MC 50
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: WPM 30
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
Other: WPM 50
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
Other: Control (WPM 0)
85.0 % maltodextrin,15.0% fat, 0% WPM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société des Produits Nestlé (SPN)

Investigators

  • Principal Investigator: Maurice Beaumont, MD, PhD, Société des Produits Nestlé (SPN)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

November 10, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Estimate)

November 27, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10.19.MET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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