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

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Whey protein isolate
Whey protein microgel
Water
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prediabetic State

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Nestlé Clinical Research Unit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Control 10

Whey protein isolate 10

Whey protein microgel 10

Control 30

Whey protein isolate 30

Whey protein microgel 30

Arm Description

100 ml Water taken 10 min before standard meal

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

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

100 ml Water taken 30 min before standard meal

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

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

Outcomes

Primary Outcome Measures

Post-prandial glucose
Incremental area under the curve

Secondary Outcome Measures

C max glucose
Incremental Cmax
T max glucose
Incremental Tmax

Full Information

First Posted
September 30, 2021
Last Updated
October 27, 2021
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT05112146
Brief Title
Effects of Whey Protein Pre-meals on Post-prandial Glucose
Official Title
Effects of Whey Protein Pre-meals on Post-prandial Glucose
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2018 (Actual)
Primary Completion Date
August 29, 2018 (Actual)
Study Completion Date
August 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control 10
Arm Type
Placebo Comparator
Arm Description
100 ml Water taken 10 min before standard meal
Arm Title
Whey protein isolate 10
Arm Type
Experimental
Arm Description
10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal
Arm Title
Whey protein microgel 10
Arm Type
Experimental
Arm Description
10g whey protein microgel in 100 ml taken 10 min before standard meal
Arm Title
Control 30
Arm Type
Placebo Comparator
Arm Description
100 ml Water taken 30 min before standard meal
Arm Title
Whey protein isolate 30
Arm Type
Experimental
Arm Description
10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal
Arm Title
Whey protein microgel 30
Arm Type
Experimental
Arm Description
10g whey protein microgel in 100 ml taken 30 min before standard meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein isolate
Intervention Description
Oral administration
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein microgel
Intervention Description
Oral administration
Intervention Type
Dietary Supplement
Intervention Name(s)
Water
Intervention Description
Oral administration
Primary Outcome Measure Information:
Title
Post-prandial glucose
Description
Incremental area under the curve
Time Frame
Hour 0 to hour 2 after standard meal consumption
Secondary Outcome Measure Information:
Title
C max glucose
Description
Incremental Cmax
Time Frame
Hour 0 to hour 2 after standard meal consumption
Title
T max glucose
Description
Incremental Tmax
Time Frame
Hour 0 to hour 2 after standard meal consumption

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Darimont
Organizational Affiliation
Nestlé Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nestlé Clinical Research Unit
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1000
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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