MedDataX Logo

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

NCT ID: NCT05112146

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-20

Study Completion Date

2018-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prediabetic State

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control 10

100 ml Water taken 10 min before standard meal

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Whey protein isolate 10

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

Group Type EXPERIMENTAL

Whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Whey protein microgel 10

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

Group Type EXPERIMENTAL

Whey protein microgel

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Control 30

100 ml Water taken 30 min before standard meal

Group Type PLACEBO_COMPARATOR

Water

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Whey protein isolate 30

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

Group Type EXPERIMENTAL

Whey protein isolate

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Whey protein microgel 30

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

Group Type EXPERIMENTAL

Whey protein microgel

Intervention Type DIETARY_SUPPLEMENT

Oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Whey protein isolate

Oral administration

Intervention Type DIETARY_SUPPLEMENT

Whey protein microgel

Oral administration

Intervention Type DIETARY_SUPPLEMENT

Water

Oral administration

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian Darimont

Role: PRINCIPAL_INVESTIGATOR

Nestlé Research

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18.08BIO

Identifier Type: -

Identifier Source: org_study_id