Effects of Mulberry Leaf Extract Formulation on Postprandial Glycemic Levels in Obese Children and Adolescents: A Pilot Study (PEDRED)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Area Under the Curve for Plasma Glucose
研究概览
简要总结
The study entitled "Effects of mulberry leaf extract formulationon Postprandial Glycemic Peak in Obese Children and Adolescents: A Pilot Study" aims to evaluate the improvement in glycemic and insulinemic levels produced by a food supplement extracted from white mulberry (Morus alba), after 12 weeks of treatment in a cohort of obese children and adolescents.
Clinical and anthropometric data (age, sex, weight, height, BMI, pubertal stage) will be collected, along with data from blood chemistry tests performed during routine follow-up visits, in accordance with Good Clinical Practice guidelines.
详细描述
At baseline (Time 0), participants undergo a comprehensive evaluation including medical history, physical examination, and anthropometric measurements. Blood tests are performed to assess liver enzymes, lipid profile, and glycated hemoglobin. Glucose metabolism is evaluated through an oral glucose tolerance test (OGTT) with repeated measurements of glucose, insulin, and C-peptide. Dietary habits and adherence to the Mediterranean diet are assessed using validated questionnaires, along with a 3-day food record. Gastrointestinal side effects and treatment adherence are also evaluated using standardized questionnaires.
Follow-up visits are scheduled at 4 weeks (T1) and 8 weeks (T2). At both time points, participants receive a physical examination and anthropometric assessment, and their dietary records, gastrointestinal symptoms, and treatment adherence are reviewed.
At 12 weeks (T3), a final evaluation is performed, including physical and anthropometric measurements, repeat blood tests, and a second OGTT. Dietary intake, gastrointestinal tolerability, and treatment adherence are reassessed to evaluate changes over the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) >95° percentile for age and sex, according to WHO growth standards
- •absence of chronic deseases
排除标准
- •diagnosis of type 1 diabetes
- •chronic use of steroid drugs
- •known allergies or hypersensitvity to any component of the stusy product (Reducose)
- •use of medications known to affect glucose metabolism
研究组 & 干预措施
placebo
Participants will receive 2 placebo sticks per day, 1 at lunch and 1 at dinner, for 12 weeks. The placebo sticks will be indistinguishable from the active product and will contain inert excipients
干预措施: Placebo (Other)
mulberry leaf extract formulation
Participants will receive 2 sticks of mulberry leaf extract formulation 250 mg per day, 1 at lunch and 1 at dinner, for 12 weeks.
干预措施: Reducose (Dietary Supplement)
结局指标
主要结局
Area Under the Curve for Plasma Glucose
时间窗: Baseline and Week 12
Calculated from plasma glucose concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Area under the curve (AUC) for plasma insulin
时间窗: Baseline and Week 12
Calculated from plasma insulin concentrations measured at 0, 30, 60, 90, and 120 minutes during the oral glucose tolerance test (OGTT).
Maximum plasma glucose concentration (Gmax)
时间窗: Baseline and Week 12
Maximum plasma glucose concentration observed during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
Time to maximum plasma glucose concentration (Tmax)
时间窗: Baseline and Week 12
Time required to reach the maximum plasma glucose concentration during the oral glucose tolerance test (OGTT), based on samples collected at 0, 30, 60, 90, and 120 minutes.
Glycated Hemoglobin
时间窗: Change in glycated hemoglobin from baseline to Week 12, measured in fasting blood samples.
Change in glycated hemoglobin (HbA1c)
Homeostasis Model Assessment of Insulin Resistance
时间窗: Baseline to Week 12
Change in HOMA-IR from baseline to Week 12, calculated from fasting plasma glucose and fasting plasma insulin values.
次要结局
- Change in body weight(Baseline, Week 4, Week 8, and Week 12)
- Change in body mass index (BMI)(baseline and week 12)
- Change in waist circumference(Baseline and week 12)
- Treatment adherence(Baseline, Week 4, Week 8, and Week 12)
研究者
Maria Felicia Faienza
Associate Professor of Paediatrics
University of Bari Aldo Moro