NCT05112146

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2018

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

September 1, 2021

Enrollment Period

9 days

First QC Date

September 30, 2021

Last Update Submit

October 27, 2021

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

  • Post-prandial glucose

    Incremental area under the curve

    Hour 0 to hour 2 after standard meal consumption

Secondary Outcomes (2)

  • C max glucose

    Hour 0 to hour 2 after standard meal consumption

  • T max glucose

    Hour 0 to hour 2 after standard meal consumption

Study Arms (6)

Control 10

PLACEBO COMPARATOR

100 ml Water taken 10 min before standard meal

Dietary Supplement: Water

Whey protein isolate 10

EXPERIMENTAL

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

Dietary Supplement: Whey protein isolate

Whey protein microgel 10

EXPERIMENTAL

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

Dietary Supplement: Whey protein microgel

Control 30

PLACEBO COMPARATOR

100 ml Water taken 30 min before standard meal

Dietary Supplement: Water

Whey protein isolate 30

EXPERIMENTAL

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

Dietary Supplement: Whey protein isolate

Whey protein microgel 30

EXPERIMENTAL

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

Dietary Supplement: Whey protein microgel

Interventions

Whey protein isolateDIETARY_SUPPLEMENT

Oral administration

Whey protein isolate 10Whey protein isolate 30
Whey protein microgelDIETARY_SUPPLEMENT

Oral administration

Whey protein microgel 10Whey protein microgel 30
WaterDIETARY_SUPPLEMENT

Oral administration

Control 10Control 30

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Water

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Christian Darimont

    Nestlé Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

November 8, 2021

Study Start

August 20, 2018

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

November 8, 2021

Record last verified: 2021-09

Locations

CH(1)