Effect of Chronic Exposure to Nextida GC-B on Glycemic Control in Adults With Normoglycemia or Prediabetes

NCT07149064 | Recruiting

• 1 other identifier: 25RSCFA01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 as assessed by glucose incremental AUC (iAUC 0-180 min).

Conditions

Normoglycemia; Prediabetes; Glycemic Control

Keywords

Nextida GC-B; glycemic control; normoglycemia; Prediabetes; postprandial glycemic control

Outcome Measures

Primary Outcomes (2)

• 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).

  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

  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)

  Day 0 to 90

• The difference in change between Nextida GC-B and placebo in postprandial glucose maximum concentration (Cmax)

  Day 0 to 90

• The difference in change between Nextida GC-B and placebo in postprandial insulin iAUC

  Day 0 to 90

• The difference in change between Nextida GC-B and placebo in postprandial insulin Tmax

  Day 0 to 90

• The difference in change between Nextida GC-B and placebo in postprandial insulin Cmax

  Day 0 to 90

Other Outcomes (9)

• Clinically relevant changes in blood pressure (BP) after supplementation.

  Day 0 to 90

• Clinically relevant changes in heart rate after supplementation.

  Day 0 to 90

• Clinically relevant changes in clinical chemistry

  Day 0 to 90

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Nextida GC-B DIETARY_SUPPLEMENT

One liquid shot contains 5 g of collagen hydrolysate.

Nextida GC-B

Placebo OTHER

One liquid shot contains non-active ingredients in Nextida GC-B (water, Erythritol, Citric Acid, DL-Malic Acid, Natural Apples Flavor, Steviol Glycosides).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Rousselot BVBA: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

RECRUITING

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 29, 2025
• Study Start: February 18, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

CA (1)