Effects of Whey Protein Pre-meals on Post-prandial Glucose

Study Overview
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Brief Summary
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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
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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).

Official Title
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Effects of Whey Protein Pre-meals on Post-prandial Glucose

Conditions
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Prediabetic State

Intervention / Treatment
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* Dietary Supplement: Whey protein isolate
* Dietary Supplement: Whey protein microgel
* Dietary Supplement: Water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control 10<br>100 ml Water taken 10 min before standard meal | Dietary Supplement: Water<br>* Oral administration<br>|
| Experimental: Whey protein isolate 10<br>10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal | Dietary Supplement: Whey protein isolate<br>* Oral administration<br>|
| Experimental: Whey protein microgel 10<br>10g whey protein microgel in 100 ml taken 10 min before standard meal | Dietary Supplement: Whey protein microgel<br>* Oral administration<br>|
| Placebo Comparator: Control 30<br>100 ml Water taken 30 min before standard meal | Dietary Supplement: Water<br>* Oral administration<br>|
| Experimental: Whey protein isolate 30<br>10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal | Dietary Supplement: Whey protein isolate<br>* Oral administration<br>|
| Experimental: Whey protein microgel 30<br>10g whey protein microgel in 100 ml taken 30 min before standard meal | Dietary Supplement: Whey protein microgel<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial glucose | Incremental area under the curve | Hour 0 to hour 2 after standard meal consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C max glucose | Incremental Cmax | Hour 0 to hour 2 after standard meal consumption | 
| T max glucose | Incremental Tmax | Hour 0 to hour 2 after standard meal consumption |