PREVENT - Prediabetes Intervention With Olive Leaf Tea
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate insulin resistance in individuals with pre-diabetes.
详细描述
This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The masking is from the responsibility of the tea supplier which was asked to send the tea/placebo codified and only reveal the codification after the end of the trial.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:
- •Fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mml per liter);
- •Plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mml per liter);
- •Glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mml per mole).
排除标准
- •Current use of medication for lowering blood cholesterol, glucose or hypertension;
- •History of chronic or severe diseases that may affect study outcomes or limit study participation;
- •Pregnancy and breastfeeding
结局指标
主要结局
HbA1c
时间窗: 12 weeks
Effect of olive leaf tea (OLT) on HbA1c after 12 weeks of intervention in individuals with prediabetes
次要结局
- Bilirubin(12 weeks)
- Alkaline Phosphatase(12 weeks)
- Fasting Plasma Glicose(12 weeks)
- Insulin(12 weeks)
- Cholesterol Total, c-HDL, c-LDL and triglycerides(12 weeks)
- Aspartate transaminase (AST) and Alanine transaminase (ALT)(12 weeks)
- Creatinine(12 weeks)
研究者
Manuela Meireles
Principal Investigator, PhD
Instituto Politécnico de Bragança