Status:
RECRUITING
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
Lead Sponsor:
INQUIS Clinical Research
Conditions:
Prediabetes
Normal Plasma Glucose
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 fir...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07174323
Start Date
September 8 2025
End Date
December 15 2025
Last Update
September 15 2025
Active Locations (1)
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1
INQUIS Clinical Research
Toronto, Ontario, Canada, M5C2N8