Dietary SupplementNCT04639726
A Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response.
A study testing Whey Protein Micro Gel and Water without Whey Protein. in people with Dietary Supplement, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dietary Supplement
- What is being tested?
- Whey Protein Micro Gel and Water without Whey Protein.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 26 Oct 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to sign written informed consent prior to study entry.
- Male or female, >18 years of age.
- Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
- Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
- Patients must have a hemoglobin value greater than or equal to 11.0 g/dL for females and 13.5 g/dL for males.
Who cannot join
- Fasting plasma glucose >220mg/dl at screening.
- Impaired kidney function, epidermal growth factor receptor of <60mL/min/1.73m2 at screening.
- BMI >40kg/m2.
- Elevated liver transaminase > 3 upper limit of normal at screening.
- Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
- Ongoing or recent (i.e. < 3month) injectable insulin therapy.
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- Ongoing or recent (i.e. < 3 month) weight loss interventions (e.g. dietary weight loss programs) or any history of bariatric surgery or any documented weight loss >5% within previous 6 months.
- Ongoing or recent (i.e. < 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption.
- Major medical/surgical event requiring hospitalization in the last 3 months.
- Known allergy and intolerance to product components or acetaminophen.
- Alcohol intake higher than 2 servings per day. A serving is 0.4dl of strong alcohols, 1dl of red or white wine, or 3dl of beer.
- Are unable to comply with protocol procedures in the opinion of the investigator.
- Have a hierarchical link with the research team members.
- Positive pregnancy test at screening.
- Patients who have been dosed in another clinical trial with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening, or patients currently participating in any investigational trial.
- Donation of blood or significant amount of blood loss within 8 weeks prior to screening. Patients must also agree to not donate blood within 8 weeks after their last visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response in Patients with Type 2 Diabetes.
This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.
- Conditions
- Dietary Supplement
- Being tested
- Whey Protein Micro Gel, Water without Whey Protein.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein Micro GelDietary supplement
The test product is whey protein microgels 10g, reconstituted in 125ml water.
Water without Whey Protein.Other
A matching placebo (125ml of water without whey protein) will be used as control.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein | Active comparator | Not described Receives: Dietary Supplement: Whey Protein Micro Gel |
| Placebo | Placebo comparator | Not described Receives: Other: Water without Whey Protein. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial glycemic excursion.
Incremental area under the curve post-prandial glycemic excursion (iAUC 0-3 hours)
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Secondary outcomes (16)
2h post-prandial glucose
Incremental area under the curve 2hours post-prandial glucose levels
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Total glucose
Total glucose AUC (tAUC 0-3hours)
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Plasma glucose iCmax
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Plasma glucose Tmax
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Plasma glucose AUC (iAUC 0-4hours, tAUC 0-4hours)
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Serum insulin
Serum insulin (iAUC 0-3hours, iCmax, Tmax, tAUC 0-3hours)
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucagon
Plasma glucagon (iAUC 0-3hours, iCmax, Tmax, tAUC 0-3hours)
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma Glucagon-like Peptide-1
Plasma GLP-1 (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Measured: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma Gastric Inhibitory Polypeptide
Plasma GIP (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Plasma ghrelin
Plasma ghrelin (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Plasma cholecystokinin
Plasma cholecystokinin (CCK) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Plasma peptide
Plasma peptide-YY (PYY) (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Serum triglycerides
Serum triglycerides (iAUC 0-2hours, iCmax, Tmax, tAUC 0-2hours)
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Gastric emptying
Gastric emptying (AUC 0-4hours, Cmax and Tmax for acetaminophen)
Measured: -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes.
Beta-cell function I
Beta-cell function I: AUC insulin 0-3hours: AUC glucose 0-3hours ratio
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Beta-cell function II
Beta-cell function II: Insulinogenic index (IGI): [insulin (30-0 minutes) (μU/mL)/glucose (30-0 minutes) (mg/dL)]
Measured: -15, 0, 30, 60, 90, and 120 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start28 Sep 2020
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary SupplementStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joel M Neutel, MD, Principal investigator, Orange County Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639726
- Sponsor's protocol ID
- 19.14.CLI
- Status last verified
- Oct 2024
- First submitted
- 19 Nov 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Single-Center, Crossover Study to Evaluate the Effects of Pre-Meal Whey Protein Microgels Administration on Post-Prandial Glycemic Response in Patients with Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT04639726
- Acronym / sponsor ID
- 19.14.CLI
- Conditions
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 20 Nov 2020 (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.
This is a mechanistic, randomized, investigator-blinded, placebo-controlled, single-center, crossover study designed to evaluate the effects of premeal administration of whey protein microgels compared to placebo on postprandial glycemia in patients with type 2 diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Protein | Active comparator | Dietary Supplement: Whey Protein Micro Gel |
| Placebo | Placebo comparator | Other: Water without Whey Protein. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to sign written informed consent prior to study entry.
- Male or female, >18 years of age.
- Established diagnosis of type 2 diabetes (documented by either HbA1c 6.5 - 10.0% or a history of type 2 diabetes diagnosis).
- Treatment naïve or on active therapy with metformin at a daily dose of 1000-3000mg at screening. Dose of metformin must have been stable for at least 3 months prior to screening.
- Patients must have a hematocrit value greater than or equal to 34.0% for females and 40% for males.
Key exclusion criteria (16 listed)
- Fasting plasma glucose >220mg/dl at screening.
- Impaired kidney function, epidermal growth factor receptor of <60mL/min/1.73m2 at screening.
- BMI >40kg/m2.
- Elevated liver transaminase > 3 upper limit of normal at screening.
- Ongoing or recent (i.e. < 3month) treatment with any oral or injectable glucose-lowering drug other than metformin.
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 Micro GelThe test product is whey protein microgels 10g, reconstituted in 125ml water. | Dietary supplement | Whey Protein |
| Water without Whey Protein.A matching placebo (125ml of water without whey protein) will be used as control. | Other | Placebo |
Primary outcome
Post-prandial glycemic excursion.
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Incremental area under the curve post-prandial glycemic excursion (iAUC 0-3 hours)
16 secondary outcomes
2h post-prandial glucose
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Total glucose
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucose
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Serum insulin
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma glucagon
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma Glucagon-like Peptide-1
Time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.
Plasma Gastric Inhibitory Polypeptide
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Plasma ghrelin
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Plasma cholecystokinin
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Plasma peptide
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Serum triglycerides
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Gastric emptying
Time frame: -15, 0, 15, 30, 45, 60, 90, 120, 180, and 240 minutes.
Beta-cell function I
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
Beta-cell function II
Time frame: -15, 0, 30, 60, 90, and 120 minutes.
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 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Joel M Neutel, MD principal investigator
Orange County Research Center
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 Micro Gel and Water without Whey Protein. in people with Dietary Supplement, run by Société des Produits Nestlé (SPN) at 1 site in United States.
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 6 inclusion and 16 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 15 Oct 2024. 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 United States. 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 glycemic excursion. (time frame: -30, -15, 0, 15, 30, 45, 60, 120,150, 180, and 240 minutes.). 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 15 Oct 2024.