PrediabetesNCT07174323
The Effects of Nextida-GC and Whey Protein on Postprandial Glycemic and Insulinemic Responses When Given 30min Before, 10min Before or With a Standardized Breakfast Test-meal in Healthy Adults With and Without Prediabetes
A study testing Peptide derived from collagen protein and Whey protein isolate in people with Prediabetes and Normal Plasma Glucose, run by INQUIS Clinical Research at 1 site in Canada.
Trial summary
The goals of this clinical trial are to learn if Nextida-GC (a peptide derived from collagen) will reduce postprandial glucose responses when taken 30 minutes before, 10 minutes before or with the first bite of a breakfast test-meal consisting or bread, margarine and jam with a drink coffee, tea or water (each subject… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Normal Plasma Glucose, Normoglycemia
- What is being tested?
- Peptide derived from collagen protein and Whey protein isolate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 8 Sep 2025to 1 Dec 2025
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-pregnant, non-lactating.
- BMI 18.5 to 35.0 kg/m² inclusive.
- n=20 with prediabetes: fasting glucose 5.6-6.9 mmol/L and/or HbA1c 5.7-6.4%.
- n=12 without prediabetes: fasting glucose <5.6 mmol/L and HbA1c <5.7%.
- Systolic blood pressure <160mmHg and diastolic blood pressure <100mmHg.
- Willing to abstain from unusual strenuous exercise and consuming alcoholic drinks for 24 hours before study days.
Show all 10Show fewer
- Willing to refrain from smoking tobacco or using marijuana in any form (including but not limited to smoking, vaping, edibles, tinctures, or other ingestible or inhalable preparations) for 12h before and during study visits.
- Willing to consume study products that contain animal derived ingredients
- Understand the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
- Eligible to receive income in Canada and covered by a health insurance plan such as OHIP.
Who cannot join
- Failure to meet any one of the inclusion criteria.
- Major trauma or surgical event within 3 months of screening.
- Use of supplements containing collagen and/or high dose of chromium (>500mcg).
- The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator.
- Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines.
- Known intolerance, sensitivity, or allergy to any ingredients in the study test meals.
- Subject is currently participating or recently (within 30 days of screening) participated in a clinical trial involving long-term exposure (greater than 24 hours) to an investigational drug, nutritional supplement, or lifestyle modification
Trial locations and contacts
1 site in 1 country.
About this study
The goals of this clinical trial are to learn if Nextida-GC (a peptide derived from collagen) will reduce postprandial glucose responses when taken 30 minutes before, 10 minutes before or with the first bite of a breakfast test-meal consisting or bread, margarine and jam with a drink coffee, tea or water (each subject will choose a drink and have the same drink each time).
The main questions it aims to answer are:
Read more
Does Nextida-GC reduce glucose responses more than whey protein?
What are the effects of Nextida-GC and whey protein on plasma glucose and serum insulin responses when given 30 minutes before eating, 10 minutes before eating, or with the breakfast test meal?
Overall, is it better to take Nextida-GC 30 minutes before eating, 10 minutes before eating, or with the breakfast test meal?
Participants will:
Come to the research center (INQUIS Clinical Research, Toronto, Ontario, Canada) on 8 separate occasions (with bewteen 3 and 14 days between visits) after an overnight fast of at least 10 hours. Each participant will undergo all 8 treatments (one treatment per visit):
Block 1
- 10 grams Nextida-GC in water 30 minutes before eating the test-meal
- 10 grams Nextida-GC in water 10 minutes before eating the test-meal
- water 30min before eating and 10g Nextida-GC in water with the test-meal
- water 30min before eating, and water with the test-meal
Block 2
- 10 grams whey protein in water 30 minutes before eating the test-meal
- 10 grams whey protein in water 10 minutes before eating the test-meal
- water 30min before eating and 10g whey protein in water with the test-meal
- water 30min before eating, and water with the test-meal
The order of the blocks will be randomized and the order of the treatments within the blocks will be randomized.
On each occasions finger-stick blood samples for measuring glucose and insulin will be obtained 30, 10 and 0 minutes before starting to eat the test-meal and 15, 30, 45, 60, 90, 120 and 180 minutes after the first bite of the test-meal.
The main outcome of the study is the area under the curve of plasma glucose from 0 to 180 minutes.
- Conditions
- Prediabetes, Normal Plasma Glucose, Normoglycemia
- Being tested
- Peptide derived from collagen protein, Whey protein isolate
- Keywords
- Glucose, Insulin, prediabetes, whey protein, collagen protein, preload
- Medical subject headings
- Prediabetic State, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide derived from collagen proteinDietary supplement
Peptide derived from collagen protein
Whey protein isolateDietary supplement
Whey protein isolate
| Study group | Role | What they receive |
|---|---|---|
| -30 min | Active comparator | 10 g protein 30 min before eating Receives: Dietary Supplement: Peptide derived from collagen protein; Dietary Supplement: Whey protein isolate |
| -10 minutes | Active comparator | 10 g protein 10 min before eating Receives: Dietary Supplement: Peptide derived from collagen protein; Dietary Supplement: Whey protein isolate |
| Control | Sham comparator | •200 ml water with no protein Receives: Dietary Supplement: Peptide derived from collagen protein; Dietary Supplement: Whey protein isolate |
| 0 minutes | Active comparator | 10 g protein with test meal Receives: Dietary Supplement: Peptide derived from collagen protein; Dietary Supplement: Whey protein isolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose iAUC 0-180
Incremental area under the glucose curve (iAUC), ignoring area below the concentration at 0 min (just before starting to eat), calculated from plasma glucose measured at 15, 30, 45, 60, 90, 120 and 180 min after starting to eat.
Measured: 0 min to 180 minutes
Secondary outcomes (7)
Insulin AUC 0-180
Incremental area under the insulin curve (iAUC), ignoring area below the concentration at 0 min (just before starting to eat), calculated from serum insulin measured at 15, 30, 45, 60, 90, 120 and 180 min after starting to eat.
Measured: 0-180 minutes
Glucose Peak Rise
Maximum glucose concentration minus glucose concentration at 0 minutes.
Measured: 0-180 minutes
Insulin Peak Rise
Maximum insulin concentration minus concentration at 0 min.
Measured: 0-180 minutes
MAGE
Maximum Amplitude of Glycemic Excursion measured as the difference between the highest and lowest plasma glucose concentrations.
Measured: 0-180 minutes
Glucose Time In Range (TIR)
The percent of time when plasma glucose is between 10.0 and 3.9 mmol/L, inclusive (plasma glucose measured at 0, 15, 30, 45, 60, 90, 120 and 180 minutes).
Measured: 0-180 min
Glucose Time Over Range (TOR)
The percent of time when plasma glucose is over 10.0 mmol/L, (plasma glucose measured at 0, 15, 30, 45, 60, 90, 120 and 180 minutes).
Measured: 0-180 min
Glucose Time Below Range (TBR)
The percent of time when plasma glucose is below 3.9 mmol/L, inclusive (plasma glucose measured at 0, 15, 30, 45, 60, 90, 120 and 180 minutes).
Measured: 0-180 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start8 Sep 2025
- Primary completion24 Nov 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- INQUIS Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Wolever, PhD, DM, Principal investigator, INQUIS Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174323
- Sponsor's protocol ID
- INQ-2504
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Nextida-GC and Whey Protein on Postprandial Glycemic and Insulinemic Responses When Given 30min Before, 10min Before or With a Standardized Breakfast Test-meal in Healthy Adults With and Without Prediabetes
- ClinicalTrials.gov ID
- NCT07174323
- Acronym / sponsor ID
- INQ-2504
- Conditions
- Prediabetes, Normal Plasma Glucose, Normoglycemia
- Keywords
- Glucose, Insulin, prediabetes, whey protein, collagen protein, preload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- INQUIS Clinical ResearchIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Sep 2025 (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 goals of this clinical trial are to learn if Nextida-GC (a peptide derived from collagen) will reduce postprandial glucose responses when taken 30 minutes before, 10 minutes before or with the first bite of a breakfast test-meal consisting or bread, margarine and jam with a drink coffee, tea or water (each subject will choose a drink and have the same drink each time).
The main questions it aims to answer are:
Does Nextida-GC reduce glucose responses more than whey protein?
What are the effects of Nextida-GC and whey protein on plasma glucose and serum insulin responses when given 30 minutes before eating, 10 minutes before eating, or with the breakfast test meal?
Overall, is it better to take Nextida-GC 30 minutes before eating, 10 minutes before eating, or with the breakfast test meal?
Participants will:
Come to the research center (INQUIS Clinical Research, Toronto, Ontario, Canada) on 8 separate occasions (with bewteen 3 and 14 days between visits) after an overnight fast of at least 10 hours. Each participant will undergo all 8 treatments (one treatment per visit):
Block 1
- 10 grams Nextida-GC in water 30 minutes before eating the test-meal
- 10 grams Nextida-GC in water 10 minutes before eating the test-meal
- water 30min before eating and 10g Nextida-GC in water with the test-meal
- water 30min before eating, and water with the test-meal
Block 2
- 10 grams whey protein in water 30 minutes before eating the test-meal
- 10 grams whey protein in water 10 minutes before eating the test-meal
- water 30min before eating and 10g whey protein in water with the test-meal
- water 30min before eating, and water with the test-meal
The order of the blocks will be randomized and the order of the treatments within the blocks will be randomized.
On each occasions finger-stick blood samples for measuring glucose and insulin will be obtained 30, 10 and 0 minutes before starting to eat the test-meal and 15, 30, 45, 60, 90, 120 and 180 minutes after the first bite of the test-meal.
The main outcome of the study is the area under the curve of plasma glucose from 0 to 180 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| -30 min | Active comparator | Dietary Supplement: Peptide derived from collagen protein, Dietary Supplement: Whey protein isolate10 g protein 30 min before eating |
| -10 minutes | Active comparator | Dietary Supplement: Peptide derived from collagen protein, Dietary Supplement: Whey protein isolate10 g protein 10 min before eating |
| Control | Sham comparator | Dietary Supplement: Peptide derived from collagen protein, Dietary Supplement: Whey protein isolate•200 ml water with no protein |
| 0 minutes | Active comparator | Dietary Supplement: Peptide derived from collagen protein, Dietary Supplement: Whey protein isolate10 g protein with test meal |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Non-pregnant, non-lactating.
- BMI 18.5 to 35.0 kg/m² inclusive.
- n=20 with prediabetes: fasting glucose 5.6-6.9 mmol/L and/or HbA1c 5.7-6.4%.
- n=12 without prediabetes: fasting glucose <5.6 mmol/L and HbA1c <5.7%.
- Systolic blood pressure <160mmHg and diastolic blood pressure <100mmHg.
Key exclusion criteria (7 listed)
- Failure to meet any one of the inclusion criteria.
- Major trauma or surgical event within 3 months of screening.
- Use of supplements containing collagen and/or high dose of chromium (>500mcg).
- The presence of any laboratory result, health condition, illness or drug use that increases risk to the subject or to others or may affect the results, as judged by the Qualified Investigator.
- Unwillingness or inability to comply with experimental procedures and to follow INQUIS safety guidelines.
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 |
|---|---|---|
| Peptide derived from collagen proteinPeptide derived from collagen protein | Dietary supplement | -10 minutes, -30 min, 0 minutes, Control |
| Whey protein isolateWhey protein isolate | Dietary supplement | -10 minutes, -30 min, 0 minutes, Control |
Primary outcome
Glucose iAUC 0-180
Time frame: 0 min to 180 minutes
Incremental area under the glucose curve (iAUC), ignoring area below the concentration at 0 min (just before starting to eat), calculated from plasma glucose measured at 15, 30, 45, 60, 90, 120 and 180 min after starting to eat.
7 secondary outcomes
Insulin AUC 0-180
Time frame: 0-180 minutes
Glucose Peak Rise
Time frame: 0-180 minutes
Insulin Peak Rise
Time frame: 0-180 minutes
MAGE
Time frame: 0-180 minutes
Glucose Time In Range (TIR)
Time frame: 0-180 min
Glucose Time Over Range (TOR)
Time frame: 0-180 min
Glucose Time Below Range (TBR)
Time frame: 0-180 min
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Prediabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
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.
Thomas Wolever, PhD, DM principal investigator
INQUIS Clinical 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 Peptide derived from collagen protein and Whey protein isolate in people with Prediabetes and Normal Plasma Glucose, run by INQUIS Clinical Research at 1 site in Canada.
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 10 inclusion and 7 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 14 Apr 2026. 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 Canada. 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?
Glucose iAUC 0-180 (time frame: 0 min to 180 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 14 Apr 2026.