32 Participants Needed

Nextida-GC + Whey Protein for Prediabetes

FM
JC
Overseen ByJanice Campbell
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: INQUIS Clinical Research
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Nextida-GC, a peptide from collagen, can lower blood sugar levels after eating, compared to whey protein. The researchers aim to determine if taking these supplements 30 minutes before, 10 minutes before, or with a meal is more effective. Individuals with prediabetes or normal blood sugar levels might be suitable candidates, particularly if they can commit to multiple visits at a research center and are comfortable eating study meals. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on dietary supplements and blood sugar management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot use supplements containing collagen or high doses of chromium, and any drug use that might affect the results is not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Nextida-GC and whey protein are generally safe and well-tolerated. Nextida-GC, a peptide derived from collagen, has been found to significantly boost the natural release of GLP-1, a hormone that helps control blood sugar levels. In one study, participants who took either 5 or 10 grams of Nextida-GC experienced an average 42% reduction in blood sugar spikes after eating, indicating effective treatment without major side effects.

Whey protein has undergone extensive study and is considered safe to consume. Research indicates that whey protein can lower blood sugar levels after meals, aiding in blood sugar control. It has been linked to improved blood sugar and insulin response without major negative effects.

These findings suggest that both treatments are safe for use, with no major side effects reported in the studies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prediabetes because they explore the timing of whey protein intake in relation to meals. Unlike most conventional treatments like lifestyle changes, metformin, or other medications that primarily focus on blood sugar regulation after meals, this approach investigates how pre-meal protein timing can influence glucose levels. The unique aspect here is the potential to control blood sugar spikes by consuming protein 30 minutes, 10 minutes, or at the start of a meal. This method could offer a simple, dietary-based strategy to manage prediabetes, which might be more accessible and have fewer side effects than traditional drugs.

What evidence suggests that this trial's treatments could be effective for prediabetes?

This trial will compare the effects of Nextida-GC and whey protein on blood sugar management in individuals with prediabetes. Studies have shown that Nextida-GC, a component of collagen, increases GLP-1, a hormone that aids in sugar management. Whey protein slows the rate at which food leaves the stomach and increases insulin, thereby lowering blood sugar levels. Research indicates that whey protein can reduce blood sugar spikes by about 1.0 mmol/L. Both treatments show promise for managing blood sugar, but further testing in this trial will determine which one is more effective.12346

Who Is on the Research Team?

TW

Thomas Wolever, PhD, DM

Principal Investigator

INQUIS Clinical Research

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with prediabetes, but not individuals with polycystic ovary syndrome or insulin resistance. Participants must be willing to visit the research center in Toronto on eight separate occasions after fasting overnight.

Inclusion Criteria

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
n=12 without prediabetes: fasting glucose <5.6 mmol/L and HbA1c <5.7%
See 7 more

Exclusion Criteria

Failure to meet any one of the inclusion criteria
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
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8 different treatments involving Nextida-GC and whey protein, with blood samples collected to measure glucose and insulin responses.

8 visits over 3-14 days between each visit
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Nextida-GC
  • Whey Protein
Trial Overview The study tests if Nextida-GC, a peptide from collagen, affects blood sugar levels differently when taken at various times before breakfast compared to whey protein. Each participant will try all treatments across multiple visits, with their effects measured via finger-stick blood samples.
How Is the Trial Designed?
4Treatment groups
Active Control
Placebo Group
Group I: -30 minActive Control2 Interventions
Group II: -10 minutesActive Control2 Interventions
Group III: 0 minutesActive Control2 Interventions
Group IV: ControlPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

INQUIS Clinical Research

Lead Sponsor

Trials
12
Recruited
400+

Citations

Effect of Chronic Exposure to Nextida GC-B on Glycemic ...The goal of this clinical trial is to investigate the safety and efficacy of Nextida GC-B on glycemic control in adults with normoglycemia ...
A Specific Collagen Hydrolysate Improves Postprandial ...The data indicate that the specific collagen hydrolysate, H80, has significant GLP‐1‐mediated effects on oral glucose tolerance in lean and prediabetic mice.
Targeting natural GLP-1 release with collagen peptides for ...The results detailed in Figure 5A and B demonstrate that oral supplementation with 10 g Nextida GC significantly enhanced natural GLP-1 ...
Study Details | NCT07174323 | The Effects of Nextida-GC ...The goals of this clinical trial are to learn if Nextida-GC (a peptide derived from collagen) will reduce postprandial glucose responses ...
Nextida GC | RousselotThe prediabetic subgroup also yielded statistically significant results at both 5 and 10 grams, showing promise for lower dosage levels in individuals with ...
Collagen Peptides Show Promise in Reducing Post-Meal ...Participants consuming 5 or 10 grams of Nextida GC experienced an average 42% reduction in blood glucose spike 30 minutes after a meal. The findings suggest ...
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