NCT07149064招募中不适用
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
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The difference in change in postprandial glycemic control between Nextida GC-B and placebo
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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
- •Provided voluntary, written, informed consent to participate in the study
- •Healthy as determined by medical history and laboratory results as assessed by QI
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Nextida GC-B (Dietary Supplement)
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.
干预措施: Placebo (Other)
结局指标
主要结局
The difference in change in postprandial glycemic control between Nextida GC-B and placebo
时间窗: 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
时间窗: Day 0 to 90
The difference in change in glycated hemoglobin (HbA1c) and glucose variability between Nextida GC-B and placebo
次要结局
- The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)(Day 1 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)
- The difference in change between Nextida GC-B and placebo in postprandial redox status as assessed by reduced and oxidized glutathione ratio (GSH/GSSG)(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)(Day 0 to 90)
- The difference in change between Nextida GC-B and placebo in postprandial hunger.(Day 0 to 90)
- The difference in change between Nextida GC-B and placebo in postprandial satiety.(Day 0 to 90)
- The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose(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(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(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.(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.(Day 0 to 90)
- The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated hemoglobin (HbA1c)(Day 0 to 30)
- The difference in change in body composition between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated albumin (GA)(Day 0 to 90)
- The difference in change in lipid profile between Nextida GC-B and placebo.(Day 0 to 90)
- The difference in change in quality of life between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in product perception between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in body weight between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in body mass index (BMI) between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in Interleukin-6 (IL-6) between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in C-reactive protein (CRP) between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in Tumor necrosis factor-α (TNF-α) between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in interferon-gamma (IFN-ɣ) between Nextida GC-B and placebo(Day 0 to 90)
- The difference in change in measures of skin health between Nextida GC-B and placebo including elasticity(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®(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.(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(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(Day 0 to 90)
- The difference in change in measures of skin health between Nextida GC-B and placebo including hydration(Day 0 to 90)
- The difference in change in measures of skin health between Nextida GC-B and placebo including firmness(Day 0 to 90)
- The difference in change in postprandial glycemic control(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)(Day 0 to 7)
- The difference in change between Nextida GC-B and placebo in fasting insulin(Day 0 to 90)
- The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose(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(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(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.(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.(Day 0 to 1)
- The difference in change in markers of protein glycation between Nextida GC-B and placebo in glycated albumin (GA)(Day 0 to 30)
- The difference in change in lipid profile between Nextida GC-B and placebo.(Day 0 to 30)
- The difference in change in body weight between Nextida GC-B and placebo(Day 0 to 30)
- The difference in change in body mass index (BMI) between Nextida GC-B and placebo(Day 0 to 30)
- The difference in change in Interleukin-6 (IL-6) between Nextida GC-B and placebo(Day 0 to 30)
- The difference in change in C-reactive protein (CRP) between Nextida GC-B and placebo(Day 0 to 30)
- The difference in change in Tumor necrosis factor-α (TNF-α) between Nextida GC-B and placebo(Day 0 to 30)
- The difference in change in interferon-gamma (IFN-ɣ) between Nextida GC-B and placebo(Day 0 to 30)
- The difference in change in quality of life between Nextida GC-B and placebo(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.(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(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(Day 0 to 30)
- The difference in change in postprandial glycemic control(Day 0 to 1)
- The difference in change in postprandial glycemic control(Day 0 to 30)
- The difference in change in postprandial glycemic control(Day 1 to 30)
- The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)(Day 0 to 1)
- The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)(Day 0 to 30)
- The difference in change between Nextida GC-B and placebo in postprandial glucose time to maximum concentration (Tmax)(Day 1 to 30)
- The difference in change from baseline between Nextida GC-B and placebo in fasting blood glucose(Day 0 to 30)
- The difference in change between Nextida GC-B and placebo in fasting insulin(Day 0 to 1)
- The difference in change between Nextida GC-B and placebo in fasting insulin(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(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(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.(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.(Day 0 to 30)
研究者
研究点 (1)
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