OverweightThermowheyNCT02303080
Whey Protein Micelles and Thermogenesis in Overweight Subjects
A study testing WPM 30, WPM 50 and MC 50 in people with Overweight, run by Société des Produits Nestlé (SPN).
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. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- WPM 30, WPM 50 and MC 50
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight (BMI range between 25.0 and 29.9 kg per m2 Healthy Having obtained his/her subjects over 20 year informed consent.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Control (WPM 0), WPM 30, WPM 50, MC 50
- Keywords
- whey protein microgels, thermogenesis
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (WPM 0)Other
85.0 % maltodextrin,15.0% fat, 0% WPM
WPM 30Other
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
WPM 50Other
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
MC 50Other
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
| Study group | Role | What they receive |
|---|---|---|
| Control (WPM 0) | Placebo comparator | 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 Receives: Other: WPM 30; Other: WPM 50; Other: MC 50 |
| WPM 30 | Active comparator | 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 Receives: Other: Control (WPM 0); Other: WPM 50; Other: MC 50 |
| WPM 50 | Active comparator | 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 Receives: Other: Control (WPM 0); Other: WPM 30; Other: MC 50 |
| MC 50 | Active comparator | 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 Receives: Other: Control (WPM 0); Other: WPM 30; Other: WPM 50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
thermic effect of food
gas exchanges through indirect calorimetry
Measured: 7 hours from baseline measurements
Secondary outcomes (1)
Whole body protein turnover
protein synthesis and breakdown
Measured: 7 hours from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maurice Beaumont, MD, PhD, Principal investigator, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303080
- Sponsor's protocol ID
- 10.19.MET
- Acronym
- Thermowhey
- Status last verified
- Nov 2014
- First submitted
- 10 Nov 2014
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30269898
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey Protein Micelles and Thermogenesis In Overweight Subjects
- ClinicalTrials.gov ID
- NCT02303080
- Acronym / sponsor ID
- Thermowhey / 10.19.MET
- Conditions
- Overweight
- Keywords
- whey protein microgels, thermogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control (WPM 0) | Placebo comparator | Other: WPM 30, Other: WPM 50, Other: MC 50400 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 |
| WPM 30 | Active comparator | Other: Control (WPM 0), Other: WPM 50, Other: MC 50400 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 |
| WPM 50 | Active comparator | Other: Control (WPM 0), Other: WPM 30, Other: MC 50400 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 |
| MC 50 | Active comparator | Other: Control (WPM 0), Other: WPM 30, Other: WPM 50400 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Overweight (BMI range between 25.0 and 29.9 kg per m2 Healthy Having obtained his/her subjects over 20 year informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control (WPM 0)85.0 % maltodextrin,15.0% fat, 0% WPM | Other | MC 50, WPM 30, WPM 50 |
| WPM 3043.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM | Other | Control (WPM 0), MC 50, WPM 50 |
| WPM 5016.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM | Other | Control (WPM 0), MC 50, WPM 30 |
| MC 5016.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC | Other | Control (WPM 0), WPM 30, WPM 50 |
Primary outcome
thermic effect of food
Time frame: 7 hours from baseline measurements
gas exchanges through indirect calorimetry
1 secondary outcome
Whole body protein turnover
Time frame: 7 hours from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Derived from this study: PubMed 30269898Kassis 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.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maurice Beaumont, MD, PhD principal investigator
Société des Produits Nestlé (SPN)
Questions about this trial
What is this clinical trial studying?
A study testing WPM 30, WPM 50 and MC 50 in people with Overweight, run by Société des Produits Nestlé (SPN).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thermic effect of food (time frame: 7 hours from baseline measurements). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303080, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.