Impact of Poplar Propolis on Insulin Homeostasis and Pancreatic Cell Function in Insulin Resistant Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M)
研究概览
简要总结
Propolis, a natural resinous mixture rich in polyphenols, produced by bees from a variety of plant sources, has shown significant therapeutic effects and may prevent the development of certain chronic diseases. Current evidence supports the beneficial effect of these bioactive phytochemicals on the management of type 2 diabetes mellitus (T2DM) and other chronic diseases. The objective of this study is to evaluate the effect of poplar propolis extract powder (PPEP) on glucose homeostasis and other clinical parameters in insulin-resistant patients (diagnosed by HOMA-IR index > 1.85 for men and > 2.07 for women).
详细描述
Backgroud: Propolis, a natural resinous mixture rich in polyphenols, produced by bees from a variety of plant sources, has shown significant therapeutic effects and may prevent the development of certain chronic diseases. Current evidence supports the beneficial effect of these bioactive phytochemicals on the management of type 2 diabetes mellitus (T2DM) and other chronic diseases. The objective of this study is to evaluate the effect of poplar propolis extract powder (PPEP) on glucose homeostasis and other clinical parameters in insulin-resistant patients (diagnosed by HOMA-IR index > 1.85 for men and > 2.07 for women).
Methods: The trial was a randomized, controlled, crossover, intervention study. Insulin-resistant patients (n=9) (8 women, 1 man), with a mean ± SD age 49 ± 7, were subjected to two periods of supplementation (propolis and placebo) for 3-months, separated by a 2-week washout period. The quantity of propolis administered was determined individually to reach 6 mg of polyphenols/kg. Fasting blood test and oral glucose tolerance test (OGTT) were performed before and after each treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥ 30 kg/m2
- •Insulin resistance defined as a HOMA-IR index > 1.85 for men and > 2.07 for women
排除标准
- •Presence of diabetes
- •Recent weight change (≥ 5% in the last 3 months)
- •Documented allergy to bee products and/or fish products
- •Positive serology for human immunodeficiency virus or hepatitis
- •High blood pressure
- •Elevated transaminases (AST > 40 IU/L ; ALT > 45 IU/L)
- •Low creatine clearance (estimated glomerular filtration rate < 90 ml/min)
- •Interfering treatment (cholesterol-lowering treatment, intestinal absorption modulating treatment, absorption modulating treatment and/or insulin sensitivity)
- •Gastrointestinal tract surgery
- •Pregnancy and / or lactation.
结局指标
主要结局
Change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M)
时间窗: 3 months
The primary outcome was change in the Matsuda-DeFronzo Insulin Sensitivity Index (ISI-M) at the end of supplementation. The ISI-M is calculated by the following formula: 10,000 / square root \[(Glu0 × Ins0) × (Glumean OGTT × Insmean OGTT)\], where Glux and Insx represent plasma glucose (mg/dL) and insulin values (UI/L), respectively, at time x min during. The ISI-M index, proposed by Matsuda and Defronzo, makes it possible to estimate insulin sensitivity derived from the OGTT
次要结局
- Change in triglyceride levels(3 months)
- Change in cholesterol levels(3 months)
- Change in high density lipoprotein (HDL) cholesterol levels(3 months)
- Change in weight(3 months)
- Change in C-reactive protein(3 months)
- Change in transaminases levels(3 months)
- Change in gamma glutamyl transferases (GGT)(3 months)
- Change in creatinine clearance(3 months)
- Change in glucose homeostasis(3 months)
- Change in body mass index (BMI)(3 months)
- Change in body fat rate(3 months)
- Change in creatinine levels(3 months)
- Change in adiponectin levels(3 months)
- Change in 8-iso-prostaglandin F2α levels(3 months)
- Change in glycated hemoglobin A1c (HbA1c) levels(3 months)
- Change in leptin levels(3 months)
- Change in insulin homeostasis(3 months)
- Change in low density lipoprotein (LDL) cholesterol levels(3 months)
- Change in body lean rate(3 months)
研究者
Jean-Francois Landrier
Principal Investigator
Aix Marseille Université