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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
Block 2
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| -30 min | Active Comparator | 10 g protein 30 min before eating |
|
| -10 minutes | Active Comparator | 10 g protein 10 min before eating |
|
| Control | Sham Comparator | •200 ml water with no protein |
|
| 0 minutes | Active Comparator | 10 g protein with test meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peptide derived from collagen protein | Dietary Supplement | Peptide derived from collagen protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 min to 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-180 minutes |
| Glucose Peak Rise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Wolever, PhD, DM | INQUIS Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INQUIS Clinical Research | Toronto | Ontario | M5C2N8 | Canada |
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Those measuring glucose and insulin
| Whey protein isolate | Dietary Supplement | Whey protein isolate |
|
Maximum glucose concentration minus glucose concentration at 0 minutes. |
| 0-180 minutes |
| Insulin Peak Rise | Maximum insulin concentration minus concentration at 0 min. | 0-180 minutes |
| MAGE | Maximum Amplitude of Glycemic Excursion measured as the difference between the highest and lowest plasma glucose concentrations. | 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). | 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). | 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). | 0-180 min |
| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
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