Effect of White Mulberry Leaf Extract Supplementation on Metabolic Markers in Overweight Adults With Early Metabolic Dysregulation Receiving Metformin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Body Weight (kg) from baseline to Week 12
研究概览
简要总结
This study tests whether a mulberry leaf extract can help adults with early cardiometabolic risk lose more weight while taking metformin.
People with cardiometabolic risk often have excess body weight, higher blood sugar, and changes in blood fats. Many take metformin to help control blood sugar. Researchers wanted to see if adding a mulberry leaf supplement could improve weight loss and support overall metabolic health.
Adults could take part if they:
- Were overweight (body mass index over 25)
- Had early signs of metabolic risk
- Had been taking metformin 1000 mg daily for at least six months
The study lasted 12 weeks. Fifty adults took part. Participants were randomly assigned, like flipping a coin, to receive either:
- Mulberry leaf extract (250 mg twice daily), or
- A placebo, which looks the same but contains no active ingredient
Participants took the capsules 10 minutes before lunch and dinner. They continued their usual diet and physical activity. Researchers contacted participants each month to check capsule use and monitor safety.
The main goal was to measure changes in:
- Body weight
- Body mass index
- Waist size
Researchers also measured blood sugar, cholesterol, liver health, and quality of life.
The study aimed to find out whether adding mulberry leaf extract to stable metformin treatment could lead to greater weight loss and support metabolic health compared to placebo.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Metformin prescribed as part of routine clinical management for early metabolic abnormalities
- •Stable glucose control for at least six months prior to enrolment
排除标准
- •pregnancy or lactation
- •severe infection
- •advanced hepatic or renal insufficiency
- •active malignancy
- •any condition deemed incompatible with study participation.
研究组 & 干预措施
Placebo
干预措施: Placebo (Dietary Supplement)
Intervention
干预措施: Mulberry Leaf Extract (Dietary Supplement)
结局指标
主要结局
Change in Body Weight (kg) from baseline to Week 12
时间窗: 12 weeks
Body weight measured in kilograms using a calibrated scale, under standardized conditions (e.g., light clothing, no shoes). Report change from baseline.
次要结局
- Change in Fasting Blood Glucose(12 weeks)
- Change in Total Cholesterol(12 weeks)
- Change in Fasting Plasma GLP-1(12 weeks)
- Change in Body Mass Index (BMI)(12 weeks)
- Change in Waist Circumference (WC)(12 weeks)
- Change in Waist-to-Height Ratio (WHtR)(12 weeks)
- Glycated Hemoglobin (HbA1c)(12 weeks)
- Change in High-Density Lipoprotein Cholesterol (HDL-C)(12 weeks)
- Change in Low-Density Lipoprotein Cholesterol (LDL-C)(12 weeks)
- Change in Triglycerides(12 weeks)
- Impact of Weight on Self-Perceptions Questionnaire (IWSP) Total Score(12 weeks)
研究者
Roberto Citarrella
Professor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo