- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02303080
Whey Protein Micelles and Thermogenesis in Overweight Subjects (Thermowhey)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: 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
|
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
|
Comparatore attivo: 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
|
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
85.0 % maltodextrin,15.0%
fat, 0% WPM
|
Comparatore attivo: 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
|
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
85.0 % maltodextrin,15.0%
fat, 0% WPM
|
Comparatore attivo: 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
|
43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
85.0 % maltodextrin,15.0%
fat, 0% WPM
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
thermic effect of food
Lasso di tempo: 7 hours from baseline measurements
|
gas exchanges through indirect calorimetry
|
7 hours from baseline measurements
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Whole body protein turnover
Lasso di tempo: 7 hours from baseline
|
protein synthesis and breakdown
|
7 hours from baseline
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Maurice Beaumont, MD, PhD, Société des Produits Nestlé (SPN)
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 10.19.MET
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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