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

Not Applicable

Completed

• Conditions: Prediabetic State

• 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

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