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OpenTrials
Completed

NCT Number: NCT05112146

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whey protein isolate

Dietary Supplement

Oral administration

Whey protein microgel

Dietary Supplement

Oral administration

Water

Dietary Supplement

Oral administration

Primary outcomes

  1. Post-prandial glucose

    Time frame: Hour 0 to hour 2 after standard meal consumption

    Incremental area under the curve

Secondary outcomes

  1. C max glucose

    Time frame: Hour 0 to hour 2 after standard meal consumption

    Incremental Cmax

  2. T max glucose

    Time frame: Hour 0 to hour 2 after standard meal consumption

    Incremental Tmax

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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