Prediabetic StateNCT05112146
Effects of Whey Protein Pre-meals on Post-prandial Glucose
A study testing Whey protein isolate, Whey protein microgel and Water in people with Prediabetic State, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- Whey protein isolate, Whey protein microgel and Water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Aug 2018to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Nestlé Clinical Research Unit
Lausanne, Canton of Vaud, 1000
About this study
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.
Read the 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).
- Conditions
- Prediabetic State
- Being tested
- Whey protein isolate, Whey protein microgel, Water
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein isolateDietary supplement
Oral administration
Whey protein microgelDietary supplement
Oral administration
WaterDietary supplement
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Control 10 | Placebo comparator | 100 ml Water taken 10 min before standard meal Receives: Dietary Supplement: Water |
| Whey protein isolate 10 | Experimental | 10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal Receives: Dietary Supplement: Whey protein isolate |
| Whey protein microgel 10 | Experimental | 10g whey protein microgel in 100 ml taken 10 min before standard meal Receives: Dietary Supplement: Whey protein microgel |
| Control 30 | Placebo comparator | 100 ml Water taken 30 min before standard meal Receives: Dietary Supplement: Water |
| Whey protein isolate 30 | Experimental | 10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal Receives: Dietary Supplement: Whey protein isolate |
| Whey protein microgel 30 | Experimental | 10g whey protein microgel in 100 ml taken 30 min before standard meal Receives: Dietary Supplement: Whey protein microgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glucose
Incremental area under the curve
Measured: Hour 0 to hour 2 after standard meal consumption
Secondary outcomes (2)
C max glucose
Incremental Cmax
Measured: Hour 0 to hour 2 after standard meal consumption
T max glucose
Incremental Tmax
Measured: Hour 0 to hour 2 after standard meal consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start20 Aug 2018
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prediabetic StateStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christian Darimont, Principal investigator, Nestlé Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112146
- Sponsor's protocol ID
- 18.08BIO
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whey Protein Pre-meals on Post-prandial Glucose
- ClinicalTrials.gov ID
- NCT05112146
- Acronym / sponsor ID
- 18.08BIO
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control 10 | Placebo comparator | Dietary Supplement: Water100 ml Water taken 10 min before standard meal |
| Whey protein isolate 10 | Experimental | Dietary Supplement: Whey protein isolate10 g whey protein isolate diluted in 100 ml taken 10 min before standard meal |
| Whey protein microgel 10 | Experimental | Dietary Supplement: Whey protein microgel10g whey protein microgel in 100 ml taken 10 min before standard meal |
| Control 30 | Placebo comparator | Dietary Supplement: Water100 ml Water taken 30 min before standard meal |
| Whey protein isolate 30 | Experimental | Dietary Supplement: Whey protein isolate10 g whey protein isolate diluted in 100 ml taken 30 min before standard meal |
| Whey protein microgel 30 | Experimental | Dietary Supplement: Whey protein microgel10g whey protein microgel in 100 ml taken 30 min before standard meal |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey protein isolateOral administration | Dietary supplement | Whey protein isolate 10, Whey protein isolate 30 |
| Whey protein microgelOral administration | Dietary supplement | Whey protein microgel 10, Whey protein microgel 30 |
| WaterOral administration | Dietary supplement | Control 10, Control 30 |
Primary outcome
Post-prandial glucose
Time frame: Hour 0 to hour 2 after standard meal consumption
Incremental area under the curve
2 secondary outcomes
C max glucose
Time frame: Hour 0 to hour 2 after standard meal consumption
T max glucose
Time frame: Hour 0 to hour 2 after standard meal consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Darimont principal investigator
Nestlé Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein isolate, Whey protein microgel and Water in people with Prediabetic State, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-prandial glucose (time frame: Hour 0 to hour 2 after standard meal consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.