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

Not Applicable

Completed

• Conditions: Prediabetic State
• Interventions: Dietary Supplement: Whey protein microgel; Dietary Supplement: Water; Dietary Supplement: Whey protein isolate

• Registration Number: NCT05112146
• Lead Sponsor: Société des Produits Nestlé (SPN)

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).

Study Timeline

• Study Start: 2018-08-20
• Primary Completion: 2018-08-29
• Study Completion: 2018-08-29
• Status Verified: 2021-09
• Study First Submitted: 2021-09-30
• Study First Submitted QC: 2021-10-27
• Last Update Submitted: 2021-10-27
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Whey protein microgel 10	Whey protein microgel	10g whey protein microgel in 100 ml taken 10 min before standard meal
Control 30	Water	100 ml Water taken 30 min before standard meal
Whey protein isolate 10	Whey protein isolate	10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal
Control 10	Water	100 ml Water taken 10 min before standard meal
Whey protein isolate 30	Whey protein isolate	10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal
Whey protein microgel 30	Whey protein microgel	10g whey protein microgel in 100 ml taken 30 min before standard meal

Primary Outcome Measures

Name	Time	Method
Post-prandial glucose	Hour 0 to hour 2 after standard meal consumption	Incremental area under the curve

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nestlé Clinical Research Unit; 🇨🇭 Lausanne, Vaud, Switzerland