Evaluation of the Efficacy of GlycoDual on Postprandial Glycemic Control and Insulin Sensitivity in Subjects With Impaired Glucose Metabolism: a Randomized, Controlled, Double-blind Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Effects on glycemia
研究概览
简要总结
The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
- the change of insulin sensitivity (HOMA-IR)
- the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
详细描述
Mild dysglycemias, such as impaired fasting glucose (IFG) and impaired glucose tolerance (IGT), represent pre-diabetic conditions characterized by a subclinical impairment of insulin sensitivity and β-cell function. Early intervention in this phase can prevent or delay the progression to full-blown diabetes. In this context, the use of nutraceutical supplements with physiological activity on glucose metabolism represents a promising and well-tolerated approach, able to effectively modulate metabolic parameters, with a good safety profile. GlycoDual is a food supplement developed to control post-prandial glycemia and improve insulin sensitivity in subjects with impaired glucose metabolism. GlycoDual contains maqui berry, blueberry, cocoa (rich in anthocyanins and epicatechin), and chromium picolinate, aimed at modulating the immediate glycemic response through the inhibition of α-glucosidase, stimulation of glucose transport and insulin sensitization. It also contains Gymnema sylvestre and zinc bisglycinate, aimed at supporting insulin secretion and contributing to the long-term regulation of glycemia The primary objective will be to evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
Secondary objectives are to estimate:
- the change of insulin sensitivity (HOMA-IR)
- the change of uricemia after 90 days of supplementation compared to placebo.
Safety objectives: Collection of the adverse events not related, related or possibly related to the study products.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index (BMI) 25.0-29.9 kg/m2
- •FPG levels between 100 and 125 mg/dl [IFG diagnosed after Oral Glucose Tolerance Test (OGTT)]
- •HOMA-IR > 2.5
- •subjects able to understand the informed consent and sign it before enrollment in the study
排除标准
- •personal history of cardiovascular disease or equivalent risk factors
- •obesity (BMI ≥ 30 kg/m²)
- •taking hypoglycemic drugs or supplements that affect glycemic metabolism
- •diabetes mellitus or IGT
- •pregnancy or breastfeeding
- •known thyroid, liver, kidney or muscle diseases
- •any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent
- •any known allergy or hypersensitivity to one or more components of the food supplement
结局指标
主要结局
Effects on glycemia
时间窗: 90 days
evaluate the efficacy of GlycoDual in reducing fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels compared to placebo after 90 days of treatment.
次要结局
- Change in Insulin sensitivity(90 days)
- Change in uricemia(90 days)
研究者
Giuseppe Derosa
Giuseppe Derosa
Fondazione IRCCS Policlinico San Matteo di Pavia