Actively Recruiting
A Randomized, Triple-blind, Placebo Controlled, Parallel Clinical Trial to Investigate the Efficacy and Safety 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
N/A
Total Duration
On this page
Sponsors
R
Rousselot BVBA
Lead Sponsor
K
KGK Science Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Nextida GC-B, a dietary supplement, on blood sugar control in adults who have normal blood sugar levels or prediabetes. The study aims to understand how Nextida GC-B affects post-meal blood sugar changes over 90 days compared to a placebo. This randomized, triple-blind trial is sponsored by Rousselot BVBA and includes adults with specific body mass index and blood sugar criteria. Participants are randomly assigned to one of two groups. One group takes a 5-gram liquid shot of Nextida GC-B about 30 minutes before two main meals daily, while the other group receives a placebo shot with no active ingredients at the same times. The study lasts 90 days, during which the effects of chronic exposure to Nextida GC-B on blood sugar and related health markers are monitored. During the trial, participants will attend clinic visits and use a continuous glucose monitor to track blood sugar levels. They will complete questionnaires and diaries related to diet, physical activity, and well-being. Researchers will measure a wide range of outcomes including changes in blood sugar control, insulin levels, hormones, inflammation markers, body weight, body composition, skin, hair and nail health, and quality of life. Safety and adherence to the study procedures will be closely observed throughout the 90-day period.
CONDITIONS
Brief 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...
- Males and females 18 years and older
- Body mass index (BMI) between 25 and 34.9 kg/m2 inclusive
- Females not of child-bearing potential (such as those sterilized or post-menopausal for at least 1 year) or females of child-bearing potential with a negative pregnancy test and agreement to use approved birth control methods
- Individuals with normoglycemia (HbA1c 60;5.9%) or prediabetes (HbA1c 6.0 to 60;6.4%) at screening
- Stable body weight with less than 5% change in the past 3 months
- Agreement to maintain current lifestyle habits during the study
- Willingness to complete study questionnaires, records, diaries, and comply with glucose monitor use
- Voluntary written informed consent
- Healthy as determined by medical history and lab results as assessed by the investigator
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy during study
- Allergy or intolerance preventing consumption of study product or standardized meals
- Metal implants or physical limitations affecting DEXA scans
- Poor venous access
- Current use of medications, supplements, or foods that may affect study product safety or efficacy
- Unstable metabolic or chronic diseases
- Significant gastrointestinal diseases
- Unstable hypertension or recent cardiovascular events
- Type 1 or type 2 diabetes
- Kidney or liver diseases except resolved kidney stones
- Thyroid conditions unless stable on medication
- Recent major surgery or planned surgery during study
- Cancer except fully excised skin basal cell carcinoma or remission over 5 years
- Autoimmune or immune compromised conditions
- HIV, Hepatitis B or C infection
- Blood or bleeding disorders
- Use of medical or chronic cannabinoid products
- Regular tobacco or nicotine use in past 6 months
- Excessive alcohol intake or recent substance abuse
- Clinically significant abnormal labs
- Blood donation near study periods
- Participation in other clinical trials recently
- Inability to give informed consent
- Any other condition or lifestyle factor affecting ability to complete study or posing risk as assessed by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 90 days
Participants take one liquid shot of either Nextida GC-B or placebo approximately 30 minutes before their two main meals daily to evaluate effects on glycemic control and related health measures.
Regular visits as scheduled during the 90-day treatment period
Trial Site Locations
Total: 1 location
1
KGK Science Inc.
London, Ontario, Canada, N6B3L1
Actively Recruiting
Research Team
M
Marc Moulin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here