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

Prediabetic State Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05112146
• Other study ID #: 18.08BIO
• Status: Completed
• Phase: N/A
• Start date: August 20, 2018
• Est. completion date: August 29, 2018

Study information

• Verified date: September 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 29, 2018
• Est. primary completion date: August 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Prediabetic State

Intervention

Dietary Supplement:
• Whey protein isolate
Oral administration
• Whey protein microgel
Oral administration
• Water
Oral administration

Locations

Country	Name	City	State
Switzerland	Nestlé Clinical Research Unit	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-prandial glucose	Incremental area under the curve	Hour 0 to hour 2 after standard meal consumption
Secondary	C max glucose	Incremental Cmax	Hour 0 to hour 2 after standard meal consumption
Secondary	T max glucose	Incremental Tmax	Hour 0 to hour 2 after standard meal consumption