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

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 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.

Conditions

• Prediabetes
• Normal Plasma Glucose
• Normoglycemia

Interventions

DIETARY_SUPPLEMENT

Peptide derived from collagen protein

Peptide derived from collagen protein

DIETARY_SUPPLEMENT

Whey protein isolate

Whey protein isolate

Sponsors & Collaborators

• INQUIS Clinical Research

  lead INDUSTRY

Principal Investigators

• Thomas Wolever, PhD, DM · INQUIS Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-09-08

Primary Completion

2025-11-24

Completion

2025-12-01

Countries

• Canada

Study Locations