Effect of Chronic Exposure to Nextida GC-B on Glycemic Co... | NCT07149064

Status Module

Name	Class
KGK Science Inc.	INDUSTRY

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Nextida GC-B	Dietary Supplement	One liquid shot contains 5 g of collagen hydrolysate.	Nextida GC-B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)	Day 0 to 90
The difference in change between Nextida GC-B and placebo in postprandial glucose maximum concentration (Cmax)

Other Outcomes

Measure	Description	Time Frame
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.	Day 0 to 90
Clinically relevant changes in heart rate after supplementation.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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:
1. 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)
2. Double-barrier method
3. Intrauterine devices
4. Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
5. Vasectomy of partner at least 6 months prior to screening
6. 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

Exclusion Criteria:

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
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

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases