Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRousselot BVBA
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Nextida GC-B
Dietary supplementOne liquid shot contains 5 g of collagen hydrolysate.
Placebo
Other interventionOne liquid shot contains non-active ingredients in Nextida GC-B (water, Erythritol, Citric Acid, DL-Malic Acid, Natural Apples Flavor, Steviol Glycosides).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Nextida GC-BExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Day 0 to 902
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
Time frame
Day 0 to 90Secondary outcomes
1
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)
Time frame
Day 0 to 902
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)
Time frame
Day 0 to 903
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
Time frame
Day 0 to 904
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
Time frame
Day 0 to 90Other outcomes
1
Clinically relevant changes in blood pressure (BP) after supplementation.
Clinically relevant changes in blood pressure (BP) after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event.
Time frame
Day 0 to 902
Clinically relevant changes in heart rate after supplementation.
Clinically relevant changes in heart rate after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event.
Time frame
Day 0 to 903
Clinically relevant changes in clinical chemistry
Clinically relevant changes in clinical chemistry (aspartate aminotransferase (AST)). Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event
Time frame
Day 0 to 904
Clinically relevant changes in clinical chemistry
Clinically relevant changes in clinical chemistry (alanine aminotransferase (ALT)) after supplementation. Safety outcome where clinically relevant changes refer to the opinion of the Qualified Investigator that changes indicates there is an Adverse Event
Time frame
Day 0 to 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rousselot BVBA
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov