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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
|
Aktiv komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
thermic effect of food
Tidsramme: 7 hours from baseline measurements
|
gas exchanges through indirect calorimetry
|
7 hours from baseline measurements
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Whole body protein turnover
Tidsramme: 7 hours from baseline
|
protein synthesis and breakdown
|
7 hours from baseline
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Maurice Beaumont, MD, PhD, Société des Produits Nestlé (SPN)
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 10.19.MET
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