Evaluation of Two Plant Formulations for the Management of Glycemia on Pre-diabetic Participants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Fytexia
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
The aim of this study is to develop a proof of concept establishing a causal relationship between glycemia improvement through combination of polyphenols-rich botanical extracts or polyphenols-rich botanical extracts associated with white kidney bean extract and chromimum picolinate + zinc bisglycinate with chronic supplementation. Chronic glycemia improvement will be assessed by following the evolution of HbA1c, postprandial glucose and insulin kinetics, and questionnaires. The study design is double blinded randomized with 3 arms and 29 volunteers per arm.
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)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting Plasma Glucose 75 - 125 mg/dL
- •HbA1c: 5.-6.5 %
- •Both sexes
- •Overweight BMI range (25-30 Kg/m2)
- •Age: 20-50 years old
排除标准
- •Metabolic/Chronical disease
- •Menopausal women
- •Being pregnant, breastfeeding or wanting to have a baby
- •Former obese with a history of yoyo effect
- •Have been involved in a weight loss program in the past 12 months or subjected to weight reduction surgery
- •Having started or quit smoking, having a high alcohol consumption
- •Have in the past been in a long-term antibiotherapy (1 month or more) and/or a regular antibiotherapy in the past 12 months
- •Allergy to olive, blackcurrant, pomegranate, grapefruit, white kidney bean, or corn.
结局指标
主要结局
HbA1c
时间窗: 12 weeks
Evaluation of changes in the glycated haemoglobin measurements in comparison of the 3 groups
Post prandial insulemia
时间窗: 12 weeks
Evaluation of changes in acute glycemia: Change in postprandial insulin in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
Post prandial glycemia
时间窗: 12 weeks
Evaluation of changes in acute and chronic glycemia: Changes in the postprandial glucose measurements in comparison of the 3 groups after the standardized breakfast at baseline, 4th, 8th and 12th week.
次要结局
- Body weight(12 weeks)
- Dual-energy X-ray (DEXA)(12 weeks)
- Magnetic resonance imaging (MRI)(12 weeks)
- Short Form 12 (SF-12) questionnaire(12 weeks)