NormoglycemiaNCT07149064
Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
A study testing Nextida GC-B in people with Normoglycemia and Prediabetes, run by Rousselot BVBA at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Normoglycemia, Prediabetes, Glycemic Control
- What is being tested?
- Nextida GC-B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 18 Feb 2026to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 18 years and older
- BMI of 25 to 34.9 kg/m2, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
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- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
- Individuals with normoglycemia (HbA1c ≤5.9%) or prediabetes (HbA1c 6.0 to ≤6.4%) at screening
- Stable body weight defined as a <5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
- Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, sleep, and skin, nail and hair habits) as much as possible throughout the study
- Willingness to complete questionnaires, records and diaries associated with the study, comply with continuous glucose monitor (CGM) device instructions, and complete all clinic visits
- Provided voluntary, written, informed consent to participate in the study
- Healthy as determined by medical history and laboratory results as assessed by QI
Who cannot join
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo or standardized meal ingredients
- Metal implants or other physical characteristics/limitations that may affect DEXA scan results as assessed by the QI
- Poor venous access as assessed by the QI
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
- Unstable metabolic disease or chronic diseases as assessed by the QI
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- Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Type I or Type II diabetes
- Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
- History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
- Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
- Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
- Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Use of medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- Clinically significant abnormal laboratory results at screening as assessed by the QI
- Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario, N6B3L1
Marc Moulin, PhD, 2267819094, mmoulin@kgkscience.com
David Crowley, MD
About this study
Official title: 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
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
- Normoglycemia, Prediabetes, Glycemic Control
- Being tested
- Nextida GC-B, Placebo
- Keywords
- Nextida GC-B, glycemic control, normoglycemia, Prediabetes, postprandial glycemic control
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nextida GC-BDietary supplement
One liquid shot contains 5 g of collagen hydrolysate.
PlaceboOther
One liquid shot contains non-active ingredients in Nextida GC-B (water, Erythritol, Citric Acid, DL-Malic Acid, Natural Apples Flavor, Steviol Glycosides).
| Study group | Role | What they receive |
|---|---|---|
| Nextida GC-B | Experimental | This group receives one liquid shot of 5 g Nextida GC-B approximately 30 minutes before their two main meals (breakfast and lunch or breakfast and dinner) daily. Receives: Dietary Supplement: Nextida GC-B |
| Placebo | Placebo comparator | This group receives one liquid shot of placebo approximately 30 minutes before their two main meals (breakfast and lunch or breakfast and dinner) daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in change in postprandial glycemic control between Nextida GC-B and placebo
The difference in change in postprandial glycemic control from baseline at Day 90 between Nextida GC-B and placebo as assessed by glucose incremental area under the curve (AUC) (iAUC 0-180 min).
Measured: Day 0 to 90
The difference in change in glycated hemoglobin (HbA1c) and glucose variability from baseline at Day 90 between Nextida GC-B and placebo
The difference in change in glycated hemoglobin (HbA1c) and glucose variability between Nextida GC-B and placebo
Measured: Day 0 to 90
Secondary outcomes (75)
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial glucose maximum concentration (Cmax)
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial glucose maximum concentration (Cmax)
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial insulin iAUC
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial insulin iAUC
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial insulin Tmax
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial insulin Tmax
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial insulin Cmax
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial insulin Cmax
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in post prandial redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial gut hormones as assessed by glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP)
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in post prandial gut hormones as assessed by glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP)
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial hunger.
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial hunger as assessed by hunger and satiety visual analogue scales (VAS). One a scale of 1 to 7, with 1 being "not hungry at all" and 7 being "very very hungry"
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial satiety.
The difference in change from baseline at Day 90 between Nextida GC-B and placebo in postprandial satiety as assessed by hunger and satiety visual analogue scales (VAS). One a scale of 1 to 7, with 1 being "not at all satisfactory and 7 being "completely satisfactory".
Measured: Day 0 to 90
The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose
The difference in change between Nextida GC-B and placebo in fasting blood glucose
Measured: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
The difference in change between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
Measured: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
The difference in change between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
Measured: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS.
The difference in change from baseline at Days 30 and 90 between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS. On a scale of 1 indicating "not hungry at all" to 10 indicating "extremely hungry".
Measured: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS.
The difference in change from baseline at Days 30 and 90 between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS. On a scale of 1 indicating "not satisfied at all" to 10 indicating "extremely satisfied".
Measured: Day 0 to 1
The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated hemoglobin (HbA1c)
The difference in change in markers of protein glycation from baseline at Day 30 between Nextida GC-B and placebo in glycated hemoglobin (HbA1c)
Measured: Day 0 to 30
The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated albumin (GA)
The difference in change in markers of protein glycation from baseline at Day 30 between Nextida GC-B and placebo in glycated albumin (GA)
Measured: Day 0 to 30
The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated albumin (GA)
The difference in change in markers of protein glycation from baseline at Day 90 between Nextida GC-B and placebo in glycated albumin (GA)
Measured: Day 0 to 90
The difference in change in lipid profile between Nextida GC-B and placebo.
The difference in change in lipid profile between Nextida GC-B and placebo from baseline at Day 30.
Measured: Day 0 to 30
The difference in change in lipid profile between Nextida GC-B and placebo.
The difference in change in lipid profile between Nextida GC-B and placebo from baseline at Day 90.
Measured: Day 0 to 90
The difference in change in body weight between Nextida GC-B and placebo
The difference in change in body weight from baseline at Day 30 between Nextida GC-B and placebo.
Measured: Day 0 to 30
The difference in change in body weight between Nextida GC-B and placebo
The difference in change in body weight from baseline at Day 90 between Nextida GC-B and placebo.
Measured: Day 0 to 90
The difference in change in body mass index (BMI) between Nextida GC-B and placebo
The difference in change in body mass index (BMI) from baseline at Day 30 between Nextida GC-B and placebo.
Measured: Day 0 to 30
The difference in change in body mass index (BMI) between Nextida GC-B and placebo
The difference in change in body mass index (BMI) from baseline at Day 90 between Nextida GC-B and placebo.
Measured: Day 0 to 90
The difference in change in body composition between Nextida GC-B and placebo
The difference in change in body composition (fat mass (kg and % of total weight) from baseline at Day 90 between Nextida GC-B and placebo as assessed by DEXA scan.
Measured: Day 0 to 90
The difference in change in Interleukin-6 (IL-6) between Nextida GC-B and placebo
The difference in change in Interleukin-6 (IL-6) from baseline at Day 30 between Nextida GC-B and placebo.
Measured: Day 0 to 30
The difference in change in Interleukin-6 (IL-6) between Nextida GC-B and placebo
The difference in change in Interleukin-6 (IL-6) from baseline at Day 90 between Nextida GC-B and placebo.
Measured: Day 0 to 90
The difference in change in C-reactive protein (CRP) between Nextida GC-B and placebo
The difference in change in C-reactive protein (CRP) from baseline at Day 30 between Nextida GC-B and placebo.
Measured: Day 0 to 30
The difference in change in C-reactive protein (CRP) between Nextida GC-B and placebo
The difference in change in C-reactive protein (CRP) from baseline at Day 90 between Nextida GC-B and placebo.
Measured: Day 0 to 90
The difference in change in Tumor necrosis factor-α (TNF-α) between Nextida GC-B and placebo
The difference in change in Tumor necrosis factor-α (TNF-α) from baseline at Day 30 between Nextida GC-B and placebo.
Measured: Day 0 to 30
The difference in change in Tumor necrosis factor-α (TNF-α) between Nextida GC-B and placebo
The difference in change in Tumor necrosis factor-α (TNF-α) from baseline at Day 90 between Nextida GC-B and placebo.
Measured: Day 0 to 90
The difference in change in interferon-gamma (IFN-ɣ) between Nextida GC-B and placebo
The difference in change in interferon-gamma (IFN-ɣ) from baseline at Day 30 between Nextida GC-B and placebo.
Measured: Day 0 to 30
The difference in change in interferon-gamma (IFN-ɣ) between Nextida GC-B and placebo
The difference in change in interferon-gamma (IFN-ɣ) from baseline at Day 90 between Nextida GC-B and placebo.
Measured: Day 0 to 90
The difference in change in quality of life between Nextida GC-B and placebo
The difference in change in quality of life from baseline at Day 30 between Nextida GC-B and placebo as assessed by the RAND SF-36 Questionnaire. On a scale of 1 to 5, with higher scores meaning a worse outcome.
Measured: Day 0 to 30
The difference in change in quality of life between Nextida GC-B and placebo
The difference in change in quality of life from baseline at Day 90 between Nextida GC-B and placebo as assessed by the RAND SF-36 Questionnaire. On a scale of 1 to 5, with higher scores meaning a worse outcome.
Measured: Day 0 to 90
The difference in change in product perception between Nextida GC-B and placebo
The difference in product perception at Day 90 between Nextida GC-B and placebo as assessed by the Product Perception Questionnaire (PPQ). Product perception is not scored on a scale.
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including elasticity
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including elasticity as assessed by Corneometer®
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including elasticity
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including elasticity as assessed by Cutometer®
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including wrinkles, texture, and age spots as assessed by Visia®
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including wrinkles, texture, and age spots as assessed by Visia®
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including subjective skin quality as assessed by Modified Skin Self-Assessment Questionnaire.
The difference in change in measures of skin health from baseline at Day 30 between Nextida GC-B and placebo including subjective skin quality as assessed by Modified Skin Self-Assessment Questionnaire. No numbering scale is used for this assessment. Scale is from "very satisfied" to "very Unsatisfied".
Measured: Day 0 to 30
The difference in change in measures of skin health between Nextida GC-B and placebo including subjective skin quality as assessed by Modified Skin Self-Assessment Questionnaire.
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including subjective skin quality as assessed by Modified Skin Self-Assessment Questionnaire.
Measured: Day 0 to 90
The difference in change in nail health between Nextida GC-B and placebo as assessed by the Modified Nail Self-Assessment Questionnaire
The difference in change in nail health from baseline at Day 30 between Nextida GC-B and placebo as assessed by the Modified Nail Self-Assessment Questionnaire. No numbering scale is used for this assessment. Scale is from "very satisfied" to "very Unsatisfied".
Measured: Day 0 to 30
The difference in change in nail health between Nextida GC-B and placebo as assessed by the Modified Nail Self-Assessment Questionnaire
The difference in change in nail health from baseline at Day 90 between Nextida GC-B and placebo as assessed by the Modified Nail Self-Assessment Questionnaire. No numbering scale is used for this assessment. Scale is from "very satisfied" to "very Unsatisfied".
Measured: Day 0 to 90
The difference in change in hair health between Nextida GC-B and placebo as assessed by the Modified Hair Self-Assessment Questionnaire
The difference in change in hair health from baseline at Day 30 between Nextida GC-B and placebo as assessed by the Modified Hair Self-Assessment Questionnaire. No numbering scale is used for this assessment. Scale is from "very satisfied" to "very Unsatisfied".
Measured: Day 0 to 30
The difference in change in hair health between Nextida GC-B and placebo as assessed by the Modified Hair Self-Assessment Questionnaire
The difference in change in hair health from baseline at Day 90 between Nextida GC-B and placebo as assessed by the Modified Hair Self-Assessment Questionnaire. No numbering scale is used for this assessment. Scale is from "very satisfied" to "very Unsatisfied".
Measured: Day 0 to 90
The difference in change in body composition between Nextida GC-B and placebo
The difference in change in body composition (lean mass (kg and % of total weight)) from baseline at Day 90 between Nextida GC-B and placebo as assessed by DEXA scan.
Measured: Day 0 to 90
The difference in change in body composition between Nextida GC-B and placebo
The difference in change in body composition (android fat (%)) from baseline at Day 90 between Nextida GC-B and placebo as assessed by DEXA scan.
Measured: Day 0 to 90
The difference in change in body composition between Nextida GC-B and placebo
The difference in change in body composition gynoid fat (%) from baseline at Day 90 between Nextida GC-B and placebo as assessed by DEXA scan.
Measured: Day 0 to 90
The difference in change in body composition between Nextida GC-B and placebo
The difference in change in android/gynoid fat ratio from baseline at Day 90 between Nextida GC-B and placebo as assessed by DEXA scan.
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including hydration
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including hydration as assessed by Corneometer®
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including firmness
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including firmness as assessed by Corneometer®
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including firmness
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including firmness as assessed by Cutometer®
Measured: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including hydration
The difference in change in measures of skin health from baseline at Day 90 between Nextida GC-B and placebo including hydration as assessed by Cutometer®
Measured: Day 0 to 90
The difference in change in postprandial glycemic control
The difference in change in postprandial glycemic control between Nextida GC-B and placebo in glucose incremental AUC (iAUC 0-180 min)
Measured: Day 0 to 1
The difference in change in postprandial glycemic control
The difference in change in postprandial glycemic control between Nextida GC-B and placebo in glucose incremental AUC (iAUC 0-180 min)
Measured: Day 0 to 30
The difference in change in postprandial glycemic control
The difference in change in postprandial glycemic control between Nextida GC-B and placebo in glucose incremental AUC (iAUC 0-180 min)
Measured: Day 1 to 30
The difference in change in postprandial glycemic control
The difference in change in postprandial glycemic control between Nextida GC-B and placebo in glucose incremental AUC (iAUC 0-180 min)
Measured: Day 1 to 90
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
Measured: Day 0 to 1
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
Measured: Day 0 to 30
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
Measured: Day 1 to 30
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
Measured: Day 1 to 90
The difference in change in glucose variability between Nextida GC-B and placebo as assessed by a continuous glucose monitor (CGM)
The difference in change in glucose variability between Nextida GC-B and placebo as assessed by a continuous glucose monitor (CGM)
Measured: Day 0 to 7
The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose
The difference in change between Nextida GC-B and placebo in fasting blood glucose
Measured: Day 0 to 30
The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose
The difference in change between Nextida GC-B and placebo in fasting blood glucose
Measured: Day 0 to 90
The difference in change between Nextida GC-B and placebo in fasting insulin
The difference in change between Nextida GC-B and placebo in fasting insulin
Measured: Day 0 to 1
The difference in change between Nextida GC-B and placebo in fasting insulin
The difference in change between Nextida GC-B and placebo in fasting insulin
Measured: Day 0 to 30
The difference in change between Nextida GC-B and placebo in fasting insulin
The difference in change between Nextida GC-B and placebo in fasting insulin
Measured: Day 0 to 90
The difference in change from baseline between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
The difference in change between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
Measured: Day 0 to 30
The difference in change from baseline between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
The difference in change between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
Measured: Day 0 to 90
The difference in change from baseline between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
The difference in change between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
Measured: Day 0 to 30
The difference in change from baseline between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
The difference in change between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
Measured: Day 0 to 90
The difference in change from baseline between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS.
The difference in change from baseline at Days 30 and 90 between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS. On a scale of 1 indicating "not hungry at all" to 10 indicating "extremely hungry".
Measured: Day 0 to 30
The difference in change from baseline between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS.
The difference in change from baseline at Days 30 and 90 between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS. On a scale of 1 indicating "not hungry at all" to 10 indicating "extremely hungry".
Measured: Day 0 to 90
The difference in change from baseline between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS.
The difference in change from baseline at Days 30 and 90 between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS. On a scale of 1 indicating "not satisfied at all" to 10 indicating "extremely satisfied".
Measured: Day 0 to 30
The difference in change from baseline between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS.
The difference in change from baseline at Days 30 and 90 between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS. On a scale of 1 indicating "not satisfied at all" to 10 indicating "extremely satisfied".
Measured: Day 0 to 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start18 Feb 2026
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NormoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149064
- Sponsor's protocol ID
- 25RSCFA01
- Status last verified
- Mar 2026
- First submitted
- 11 Aug 2025
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07149064
- Acronym / sponsor ID
- 25RSCFA01
- Conditions
- Normoglycemia, Prediabetes, Glycemic Control
- Keywords
- Nextida GC-B, glycemic control, normoglycemia, Prediabetes, postprandial glycemic control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nextida GC-B | Experimental | Dietary Supplement: Nextida GC-BThis group receives one liquid shot of 5 g Nextida GC-B approximately 30 minutes before their two main meals (breakfast and lunch or breakfast and dinner) daily. |
| Placebo | Placebo comparator | Other: PlaceboThis group receives one liquid shot of placebo approximately 30 minutes before their two main meals (breakfast and lunch or breakfast and dinner) daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Males and females 18 years and older
- BMI of 25 to 34.9 kg/m2, inclusive
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
- Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Key exclusion criteria (27 listed)
- Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo or standardized meal ingredients
- Metal implants or other physical characteristics/limitations that may affect DEXA scan results as assessed by the QI
- Poor venous access as assessed by the QI
- Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product (Section 7.3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nextida GC-BOne liquid shot contains 5 g of collagen hydrolysate. | Dietary supplement | Nextida GC-B |
| PlaceboOne liquid shot contains non-active ingredients in Nextida GC-B (water, Erythritol, Citric Acid, DL-Malic Acid, Natural Apples Flavor, Steviol Glycosides). | Other | Placebo |
Primary outcome
The difference in change in postprandial glycemic control between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in postprandial glycemic control from baseline at Day 90 between Nextida GC-B and placebo as assessed by glucose incremental area under the curve (AUC) (iAUC 0-180 min).
The difference in change in glycated hemoglobin (HbA1c) and glucose variability from baseline at Day 90 between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in glycated hemoglobin (HbA1c) and glucose variability between Nextida GC-B and placebo
75 secondary outcomes
The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial glucose maximum concentration (Cmax)
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial insulin iAUC
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial insulin Tmax
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial insulin Cmax
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial gut hormones as assessed by glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP)
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial hunger.
Time frame: Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial satiety.
Time frame: Day 0 to 90
The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose
Time frame: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting Redox status as assessed by GSH/GSSG
Time frame: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting gut hormones as assessed by GLP-1 and GIP
Time frame: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting hunger as assessed by hunger and satiety VAS.
Time frame: Day 0 to 1
The difference in change from baseline between Nextida GC-B and placebo in fasting satiety as assessed by hunger and satiety VAS.
Time frame: Day 0 to 1
The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated hemoglobin (HbA1c)
Time frame: Day 0 to 30
The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated albumin (GA)
Time frame: Day 0 to 30
The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated albumin (GA)
Time frame: Day 0 to 90
The difference in change in lipid profile between Nextida GC-B and placebo.
Time frame: Day 0 to 30
The difference in change in lipid profile between Nextida GC-B and placebo.
Time frame: Day 0 to 90
The difference in change in body weight between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in body weight between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in body mass index (BMI) between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in body mass index (BMI) between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in body composition between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in Interleukin-6 (IL-6) between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in Interleukin-6 (IL-6) between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in C-reactive protein (CRP) between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in C-reactive protein (CRP) between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in Tumor necrosis factor-α (TNF-α) between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in Tumor necrosis factor-α (TNF-α) between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in interferon-gamma (IFN-ɣ) between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in interferon-gamma (IFN-ɣ) between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in quality of life between Nextida GC-B and placebo
Time frame: Day 0 to 30
The difference in change in quality of life between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in product perception between Nextida GC-B and placebo
Time frame: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including elasticity
Time frame: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including elasticity
Time frame: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including wrinkles, texture, and age spots as assessed by Visia®
Time frame: Day 0 to 90
The difference in change in measures of skin health between Nextida GC-B and placebo including subjective skin quality as assessed by Modified Skin Self-Assessment Questionnaire.
Time frame: Day 0 to 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nextida GC-B in people with Normoglycemia and Prediabetes, run by Rousselot BVBA at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Moulin, PhD (2267819094, mmoulin@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in change in postprandial glycemic control between Nextida GC-B and placebo (time frame: Day 0 to 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.