A Randomized, Double-blind, Placebo-controlled, Cross-over Clinical Trial to Assess the Effect of Metaberine® on Postprandial Blood Glucose in Prediabetic Individuals
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the effect of the investigational product intake on lowering postprandial blood glucose via an oral glucose tolerance test compared to placebo
研究概览
简要总结
This is a double blind, placebo-controlled, randomized, cross-over study. The main objective of the study is to assess the improvement in postprandial blood glucose in prediabetic subjects following administration of the test product for 14 days. Subjects who fulfil the eligibility criteria will be enrolled into the study after signing the informed consent form. After the informed consent process, demographic surveys, medical history, medication usage assessments, details of prior and concomitant medications, physical measurements, vital signs will be evaluated. After passing the eligibility criteria, 36 subjects will be randomized into 2 treatment arms to receive either the IP or placebo. This will be followed by a wash-out period and then the subjects will be crossed-over to the alternate treatment . During both the treatment periods, anthropometric measurements will be taken.Blood samples will be collected for efficacy assessment. On the follow-up assessment visit, the subjects will have to come in fasting and consume the test product only at the study center. The subject diary shall be provided to the subjects to record the study IP administration, side effects, and concomitant medication details during the study duration. All subjects shall be instructed to complete the subject diary after each study IP administration. The study will be conducted in 5 visits over a period of 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with fasting blood glucose levels between 100 mg per dL and 125 mg per dL 2.Subjects with post-prandial blood glucose level of 140 to 199 mg per dL 3.Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4.Subject willing and able to give informed consent and comply with the study procedures 5.Subjects who agrees to participate in this human application test and signs a written consent form before the test begins.
排除标准
- •1.Subjects with a fasting blood sugar of greater or equal to 126 mg per dL, random blood sugar of greater or equal to 200 mg per dL, or patients with diabetes taking oral hypoglycemic agents or insulin 2.Subjects with glycated hemoglobin levels greater or equal to 6.5 percent 3.Subjects diagnosed with type 1 or type 2 diabetes 4.Subjects currently taking medications or dietary supplements related to diabetes 5.Subjects with clinically diagnosed chronic diseases 6.Subjects who are currently receiving treatment for severe cardiovascular, immune, respiratory, hepatobiliary, renal and urinary, nervous, musculoskeletal, psychological, infectious diseases, malignant tumors 7.Subjects with uncontrolled high blood pressure 8.Subjects with a history of excessive alcohol consumption or substance abuse 9.Subjects with uncontrolled thyroid disorders 10.Women who are currently pregnant, breastfeeding, or planning to become pregnant during the study period 11.Women of childbearing potential who are unable to use approved contraceptive methods 12.Subjects currently enrolled in another clinical trial or who have participated in a clinical trial within the past 30 days 13.Subjects with allergies to study-related interventions 14.Subjects with a history of significant adverse reactions to similar investigational products 15.Subjects who, in the judgment of the principal investigator, are unlikely to comply with study procedures or have conditions that could interfere with study completion.
结局指标
主要结局
To assess the effect of the investigational product intake on lowering postprandial blood glucose via an oral glucose tolerance test compared to placebo
时间窗: Day 0, Day 14
次要结局
- Overall Safety(Day 0, Day 14)
- To evaluate the effects of the investigational product on biomarker(Day 0, Day 14)
- To evaluate the effects of pharmacokinetic assessment(Day 0, Day 14)
研究者
Dr Devendra Naik N
BGS Global Institute of Medical Sciences