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
NCT ID: NCT07174323
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
32 participants
INTERVENTIONAL
2025-09-08
2026-01-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Assessment of the Glycemic Responses to Nutritional Products-INQ-2526
NCT07243743
Effects of a Collagen Supplement on Quality of Life, Appetite and Glycaemic Control
NCT07229014
The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults
NCT00988182
Investigating the Effects of Glucodia™ on Glucose Parameters, Triglycerides and Body Weight
NCT02322294
Liquid or Solid State of Food on Glycaemia, Lipaemia and Insulinaemia
NCT02875275
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
-30 min
10 g protein 30 min before eating
Peptide derived from collagen protein
Peptide derived from collagen protein
Whey protein isolate
Whey protein isolate
-10 minutes
10 g protein 10 min before eating
Peptide derived from collagen protein
Peptide derived from collagen protein
Whey protein isolate
Whey protein isolate
Control
•200 ml water with no protein
Peptide derived from collagen protein
Peptide derived from collagen protein
Whey protein isolate
Whey protein isolate
0 minutes
10 g protein with test meal
Peptide derived from collagen protein
Peptide derived from collagen protein
Whey protein isolate
Whey protein isolate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Peptide derived from collagen protein
Peptide derived from collagen protein
Whey protein isolate
Whey protein isolate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
INQUIS Clinical Research
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Wolever, PhD, DM
Role: PRINCIPAL_INVESTIGATOR
INQUIS Clinical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
INQUIS Clinical Research
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INQ-2504
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.