A Prospective, Randomized, Double Blinded, Placebo Controlled, ParallelGroup, Proof of Concept Study to Assess the Effect of Nutraceutical Formulations in Pre-diabetic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety : number of subjects reporting any AE, treatment emergent AE (TEAE), any serious AE (SAE), any study product-related AE, any study product related SAE, and discontinuations due to AE.
研究概览
简要总结
This is a randomized, double blind, parallel group, placebo-controlled single-centre trial to study the safety and efficacy 3 botanical nutraceutical formulations to be consumed twice daily for a period of 30 days in 56 pre-diabetic subjects in India.
The available literature suggests that the natural extracts from certain plants (cinnamon, fenugreek, ginger etc.) have the potential to improve the blood glucose levels, hemoglobin A1c levels, and other components of metabolic syndrome such as dyslipidemia and obesity, when combined with lifestyle measures. Currently, there is no standard-of-care for prediabetic subjects, except diet and lifestyle modifications. It is hypothesized that botanical formulations containing combinations of natural extracts from such plants i.e. drum stick, bitter melon, cinnamon, fenugreek, gurmar, ginger may benefit the glucose and lipid profile as well as body weight in prediabetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged between 25-65 years
- •Subjects with BMI of ≥23 to ≤ 35 kg/m2
- •Subject with a HbA1c levels of 5.7-6.4% (39-46 mmol/mol) as per the American Diabetes Association at the time of screening
- •Subjects with liver (alanine transaminase, aspartate transaminase, total and direct bilirubin, gamma glutamyl transferase, alkaline phosphatase, total proteins, and albumin) and renal (serum creatinine and blood urea nitrogen) function parameters within normal laboratory reference range at screening
- •Females of childbearing potential must have a negative serum pregnancy test (human chorionic gonadotropin, beta subunit [β-hCG]) at screening
- •Males and females of childbearing potential willing to practice appropriate birth control during the entire duration of the study.
- •Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care
- •Subject is willing to provide written informed consent
- •Subject is willing, able and likely to comply with all study procedures and restrictions.
排除标准
- •1.Subject with a history of diabetes mellitus (type 1/ type 2/ gestational/secondary etc.) 2.Subject has used any anti-diabetic medication for blood sugar control or other medical conditions (e.g. metformin in polycystic ovarian disease)any time during the past 6 months
- •Subject is taking medications known to interfere with glucose metabolism e.g. systemic corticosteroids, protease inhibitors, antidepressants, or antipsychotics) or any other medications in the opinion of investigator that may interfere with study outcomes
- •Subjects with a history of use of other herbal or nutritional supplements that modify glucose absorption and/or metabolism in the past 6 months
- •Subjects with a history of use of weight loss drugs (orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion etc) in the past 6 months.
- •Subject has had a weight loss or gain of greater ≥5% of body weight in the 6 months prior to screening.
- •Hemoglobin levels of <11 g/dl
- •Subject with a history of clotting/bleeding disorders such as hemophilia,Von Willebrand disease, disseminated intravascular coagulation, vitamin K deficiency or subjects who required blood transfusion in the past 3 months.
- •Subject with history of significant renal, hepatic, cardiovascular, hematologic, metabolic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, neurologic, endocrine dysfunction, malignancy, or any other significant medical illness or disorder which, in the judgment of the investigator could interfere with the study or require treatment(s) which might interfere with study or which may pose risk to the patient
- •History of drug abuse or alcohol consumption (>20 g/day in women and >30 g/day in men) and smoking (>5 pack-years cigarettes)
- •History of participation in other interventional studies within last 60 days
- •History of blood donation within last 30 days
- •Subjects with inadequate peripheral venous access, such that intravenous catheterization for serial blood collection is difficult.
- •Subject is pregnant or breast-feeding at the time of screening, or planning to be pregnant during the study
- •Subject has known allergies to the herbal products or allergy to any of the components of the study product
- •Any other condition, that in the investigator’s judgment, might interfere with study objectives.
结局指标
主要结局
Safety : number of subjects reporting any AE, treatment emergent AE (TEAE), any serious AE (SAE), any study product-related AE, any study product related SAE, and discontinuations due to AE.
时间窗: 30 days of study product administration
Efficacy endpoints:
时间窗: 30 days of study product administration
change in fructosamine, fasting plasma glucose level and serum Insulin levels, fasting serum lipids and body weight from Baseline to 30 days between the treatment arms
时间窗: 30 days of study product administration
change in blood glucose levels based on OGTT after 30 days of treatment with study products
时间窗: 30 days of study product administration
次要结局
- NA(NA)