Prediabetic State
Conditions
Brief summary
The aim of this project was to determine if an administration of either 10 g of whey protein isolate or 10 g of whey protein microgels 30 or 10 min before a standard meal could reduce postprandial glucose response in obese subjects.
Detailed description
Monocentric, controlled, randomized, open, complete cross-over study design where participants will take 2 test products or water (negative control) at 2 different time points. The targeted population will be 16 completely healthy males and females at risk for pre-diabetes. Primary objective: To quantify the effects of whey protein pre-meals administrated at 30 or 10 min before a meal on post-prandial glucose in the interstitial tissue, as compared to water as negative control. Secondary objective: To compare glucose response of the different pre-meals (water, whey protein isolate, whey protein micelles).
Interventions
DIETARY_SUPPLEMENTWhey protein isolate
Oral administration
DIETARY_SUPPLEMENTWhey protein microgel
Oral administration
DIETARY_SUPPLEMENTWater
Oral administration
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female participant * Age between 40 and 65 years * BMI higher than 27.0 kg/m2 * Sedentarity (no more than 30 min of walk per day). * Able to understand and sign an informed consent form
Exclusion criteria
* Any known metabolic disease including diabetes or chronic drug intake (aspirin, vitamin C and mineral supplements, steroids, protease inhibitors, antidepressants, anxiolytic, or antipsychotics…) possibly impacting (to the opinion of the medical doctor): * The digestion or absorption of nutrients * The postprandial glucose response * Major medical/surgical event requiring hospitalization in the last 3 months, to the opinion of the medical doctor * Known allergy and intolerance to products components * Medically known cutaneous hypersensitivity to adhesives and plasters * Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. * Smokers * Volunteer who cannot be expected to comply with the protocol * Subject having a hierarchical link with the research team members
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-prandial glucose | Hour 0 to hour 2 after standard meal consumption | Incremental area under the curve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C max glucose | Hour 0 to hour 2 after standard meal consumption | Incremental Cmax |
| T max glucose | Hour 0 to hour 2 after standard meal consumption | Incremental Tmax |
Countries
Switzerland
Outcome results
None listed