An Open Label, Prospective, Non-Randomised, Comparative, Two Arm Clinical Study to Evaluate the Effect of Pre-Meal Supplementation with Glucophil® of K.-W. Pfannenschmidt GmbH on Carbohydrate Metabolism Parameters Post High Carbohydrate Meal in Euglycemic and Prediabetic Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
Study Design: Open label, Prospective, Non Randomised, Comparative, Two Arm Clinical study.
Indication: Carbohydrate Metabolism in Euglycemic and Pre Diabetic Adults
Investigational Product: Glucophil®
Comparator: Not Applicable. Not applicable. Comparison is between euglycemic and prediabetics.
Dose, Dosage of Glucophil® Dosage: 2 g to be dissolved in 200 mL of lukewarm water, mixed well and consumed 20 minutes before carbohydrate rich meal. Treatment Duration: Not applicable. Single consumption of the product is tested for three consecutive days. Route of Administration: Oral
Subject Population: Adults aged between 18 and 75 years who are either euglycemic or prediabetic.
Number of Subjects: 16 Evaluable Subjects
Treatment Arms: Two Treatment Arm I – 8 Subjects – Euglycemic Volunteers Treatment Arm II – 8 Subjects – Prediabetic Volunteers
Assessments (Day 1, Day3, Day 4, Day 5) Fasting Blood Glucose Fasting Insulin Post Prandial Glucose (30, 60, 90, 120 Minutes) Post Prandial Insulin (120 Minutes)
Background of the study: Metabolic disorders in which hyperglycaemia lasts over a longer period leading to several other complications. It is characterized by supraphysiological glucose due to the deficiency in insulin secretion or insulin receptor or post receptor events that results in the disturbances in the biochemical pathways of carbohydrates, fats and protein. Moreover, the impaired metabolism leads to the progression and aggravation of oxidative stress through different mechanisms like glucose autoxidation, protein glycation, etc. Studies direct that the incidence of diabetes will continue to rise in the future due to growing prevalence of obesity, accelerating aging populations, environmental factors and sedentary lifestyles
**Purpose of the Study:**Type 2 Diabetes is linked to a deficiency in D- Chiro Inositol (DCI), a naturally occurring inositol that is both produced within the body and obtained through dietary sources. DCI plays a crucial role as a secondary messenger for insulin. A deficiency in DCI exacerbates insulin resistance and impairs glucose metabolism. Glucophil® is an extract of D-Pinitol derived from the fruit of the carob tree (Ceratonia siliqua). This natural ingredient comprising 97% D-Pinitol, effectively mimics insulin, promoting effective and healthy management of blood sugar levels.
This clinical study aims to evaluate the efficacy and safety of Glucophil® carbohydrate metabolism parameters post high carbohydrate meal in euglycemic and prediabetic adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Treatment Arm I
- •Clinically healthy volunteers aged between 18 and 75 years (all genders)
- •Subjects with HbA1C less than 5.7 per cent at the time of screening Treatment Arm II
- •Prediabetic adults aged between 18 and 75 years (all genders).
- •Subjects with HbA1C between 5.7 per cent & 6.4 per cent at the time of screening
- •Naive subjects or subjects who have not consumed any medicine or product or supplement intended towards management of glucose levels, carbohydrate metabolism for 30 days prior to screening and willing to abstain during the study period.
- •Both Treatment Arms
- •Subjects who are not currently on a specialized diet not limited to low carb high protein, keto, paleo etc.
- •and have not attempted such a diet for 30 days prior to screening.
- •Subjects who have not started any specified physical activity not limited to yoga, Pilates, aerobic, strength training or 10 K steps per day regimen, upto 30 days prior to screening.
- •Subjects who are not any medicine or product or supplement intended towards weight management, weight loss etc.
- •Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
- •Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •Subjects who are morbidly obese.
- •BMI greater than or equal to 30 kg per m
- •Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
- •Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
- •Subjects on remission from cancer of any type less than 5 years at the time of screening.
- •Subjects who are planning a pregnancy and or or currently breastfeeding.
- •Subjects who have participated in a clinical study less than 1 month before screening.
- •Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.), any medical condition that is unstable or poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
- •Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
- •Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
研究者
Dr VT Sriraam
Raam Clinic