A Phase II, Placebo-Controlled, Randomized, Safety and Efficacy Study to Evaluate the Change in Hemoglobin A1c Levels in Type 2 Diabetic Subjects While Taking Nutralin
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Blood Sugar
研究概览
简要总结
The purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.
详细描述
The investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. Observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. An initial Phase 1 study tested the product in a brownie form. The product has been reformulated to capsule form for the Phase 2 study.
The hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women who are at least 18 years old
- •Diagnosis of Type 2 Diabetes
- •Has been on stable diabetes medication/insulin for the past three months
排除标准
- •Women who are pregnant, breastfeeding or planning to become pregnant
- •Diagnosis of Celiac Disease or gluten intolerance
- •Current or active kidney disease
- •Current or active liver disease
- •Any food allergies
结局指标
主要结局
Blood Sugar
时间窗: 16 weeks
blood sugar levels
HgA1c reduction
时间窗: 16 weeks
reduction of Hemoglobin A1c levels
次要结局
- Diabetes medication(16 weeks)