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

Nestlé

Status: Completed

Conditions: Prediabetic State

Treatments: Dietary Supplement: Water; Dietary Supplement: Whey protein microgel; Dietary Supplement: Whey protein isolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT05112146

18.08BIO

Details and patient eligibility

About

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.

Full 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).

Enrollment: 16 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 6 patient groups, including a placebo group

Control 10

Placebo Comparator group

Description:

100 ml Water taken 10 min before standard meal

Treatment:

Dietary Supplement: Water

Whey protein isolate 10

Experimental group

Description:

10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal

Treatment:

Dietary Supplement: Whey protein isolate

Whey protein microgel 10

Experimental group

Description:

10g whey protein microgel in 100 ml taken 10 min before standard meal

Treatment:

Dietary Supplement: Whey protein microgel

Control 30

Placebo Comparator group

Description:

100 ml Water taken 30 min before standard meal

Treatment:

Dietary Supplement: Water

Whey protein isolate 30

Experimental group

Description:

10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal

Treatment:

Dietary Supplement: Whey protein isolate

Whey protein microgel 30

Experimental group

Description:

10g whey protein microgel in 100 ml taken 30 min before standard meal

Treatment:

Dietary Supplement: Whey protein microgel