Actively Recruiting
Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
Led by Rousselot BVBA · Updated on 2026-03-16
60
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
Sponsors
R
Rousselot BVBA
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to investigate the safety and efficacy of Nextida GC-B on glycemic control in adults with normoglycemia and prediabetes. The main question it aims to answer is: What is the difference in change in postprandial glycemic control from baseline at Day 90 between Nextida GC-B and placebo as assessed by glucose incremental AUC (iAUC 0-180 min).
CONDITIONS
Official Title
Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years and older
- Body mass index (BMI) between 25 and 34.9 kg/m2, inclusive
- Females not able to have children due to sterilization or post-menopause for at least 1 year
- Females able to have children must have a negative pregnancy test and use approved birth control during the study
- Individuals with normal blood sugar (HbA1c 6.9%) or prediabetes (HbA1c 6.0 to 6.4%) at screening
- Stable body weight with less than 5% change in the last 3 months
- Willing to maintain current lifestyle habits throughout the study
- Agree to complete study questionnaires, diaries, and use continuous glucose monitoring
- Provide voluntary written consent
- Healthy based on medical history and lab results as assessed
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during the study
- Allergy or intolerance preventing use of study products or meal ingredients
- Metal implants or physical issues affecting DEXA scans
- Poor venous access
- Use of medications or supplements affecting study product safety or efficacy
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable high blood pressure
- Diagnosis of Type I or II diabetes
- Recent significant cardiovascular events
- Kidney or liver diseases except symptom-free kidney stones
- Thyroid conditions unless on stable treatment
- Major surgery within past 3 months or planned surgery during study
- Cancer except certain skin cancers or cancers in full remission over 5 years
- Autoimmune or immune-compromised conditions
- HIV, Hepatitis B or C
- Blood or bleeding disorders
- Use of medical or frequent recreational cannabinoid products
- Regular tobacco or nicotine use in past 6 months
- High alcohol consumption or substance abuse
- Abnormal lab results
- Recent blood donation or participation in other clinical trials
- Unable to give informed consent
- Any other condition or lifestyle factor that may affect study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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