Randomized Double Blind Factorial Assay, Aloe Vera (AV) And/Or Cnidoscolus Chayamansa (CC) Versus Placebo, Reduction Of High Blood Glucose In Women With Metabolic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- Reduction of elevated blood sugar (HbA1c) by Immunoturbidimetric test (One-HbA1c FS) via Star-Dust MC15; both from Diagnostic systems international (DiaSys); its coefficient of variation was 1.6%.
研究概览
简要总结
High blood sugar and adiposity are part of Metabolic syndrome (about 24% of adults harbor it). The main approach, weight reduction, is often unattainable. Aloe Vera (barbadensis) (AV) and cnidoscolus chayamansa (McVaugh)(CC) are two vegetables that seem to have an effect on blood glucose and body weight.
The study aims to determine if the intake of aloe gel and/or Chaya infusion can reduce high blood sugar in adult women with pre-diabetes (Metabolic Syndrome).
Methods: A Factorial assay, double blind, cross-over-controlled with random assignment, to four treatments: AV and CC, AV and Placebo 1, Placebo 2 and CC, and Placebo 1 and Placebo 2, at the outpatient clinic of the university Hospital and a community clinic.
Two treatment periods of 4 weeks intermediated by one week for wash-out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult women living in Monterrey, Mexico with at least three of the following:
- •waist line equal or larger than 88 cm
- •fasting blood sugar between 100-140 mg/dL without symptoms or known glucose intolerance or diabetes treated only with diet
- •known high blood pressure or 2/3 readings systolic > 130 mmHg, diastolic > 85
- •HLD < 50 mg/dL or triglycerides > 150 mg/dL
排除标准
- •Pregnancy or nursing
- •On anti-diabetic agents
- •Diabetic symptoms or advanced DM complications
- •Severe behavioral problems
结局指标
主要结局
Reduction of elevated blood sugar (HbA1c) by Immunoturbidimetric test (One-HbA1c FS) via Star-Dust MC15; both from Diagnostic systems international (DiaSys); its coefficient of variation was 1.6%.
时间窗: baseline, and at the end of each of 2 treatment periods of 4 weeks
次要结局
- Tolerance assessed by weekly inquiry of effort needed to take the product, wellbeing, energy, gastrointestinal complains, control of appetite and general complaints.(after each week taking the product)
- Significant changes on hematic biometry and liver function test and evaluation of any symptoms reported.(baseline, and after four weeks of treatment or sooner if needed)
研究者
Lilia Csrdenas-Ibarra
MD
Universidad Autonoma de Nuevo Leon