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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetic State
• Intervention / Treatment: Dietary supplement: Water; Dietary supplement: Whey protein isolate; Dietary supplement: Whey protein microgel

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Nestlé Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control 10; 100 ml Water taken 10 min before standard meal	Dietary supplement: Water; Oral administration
Experimental: Whey protein isolate 10; 10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal	Dietary supplement: Whey protein isolate; Oral administration
Experimental: Whey protein microgel 10; 10g whey protein microgel in 100 ml taken 10 min before standard meal	Dietary supplement: Whey protein microgel; Oral administration
Placebo Comparator: Control 30; 100 ml Water taken 30 min before standard meal	Dietary supplement: Water; Oral administration
Experimental: Whey protein isolate 30; 10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal	Dietary supplement: Whey protein isolate; Oral administration
Experimental: Whey protein microgel 30; 10g whey protein microgel in 100 ml taken 30 min before standard meal	Dietary supplement: Whey protein microgel; Oral administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Christian Darimont, Nestlé Research

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2018
• Primary Completion (Actual): August 29, 2018
• Study Completion (Actual): August 29, 2018

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 18.08BIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No