NCT07585630尚未招募2 期
Double-Blind Randomized Controlled Trial of A1Cantus Drink vs. Placebo for Reduction of Ha1c
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The investigators will conduct a randomized controlled 2-arm parallel trial of A1c Drink vs. Placebo over a 3-month period and compare changes in Ha1c from baseline to 3 months. Investigator and study personnel, as well as participants, will be blinded to drink assignments.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 21 years of age or older and not older than 75 recruited from UCR Health
- •Clinical diagnosis of type II DM with Ha1c >= 8 but less than or equal to 10
- •Stable medications for at least 6 months
- •Speak Spanish and/or English
- •Sign an informed consent form
- •No other members in their household are participating in the study
排除标准
- •Patients <21 years of age, who do not have type II DM, whose Ha1c is less than 8 or > 10,
- •Have major complications of diabetes, including CKD, diabetic retinopathy, ADVD risk > 5, or history of CVD/stroke
- •Do not speak and understand either English or Spanish well
- •Allergic to cinnamon
- •Severe diseases, such as cancer
- •Compromised immune system
- •Eating disorders
- •BMI of 40 or higher
- •Already have a family member participating in the study
- •Substance use disorder
研究组 & 干预措施
A1C Drink
Experimental
The A1C drink is currently on the market with natural active ingredients.
干预措施: A1C Drink (Dietary Supplement)
Placebo Drink
Placebo Comparator
The placebo drink will be formulated to closely match the active drink in taste, color and mouthfeel, while removing all active ingredients.
干预措施: Placebo drink (Other)
结局指标
主要结局
Hemoglobin A1C
时间窗: 3 months
Change in Ha1c from baseline to 3 months. To test the efficacy of the A1Cantus drink in improving glycemic control in patients with Type II Diabetes
次要结局
- Reduction in A1C(3 months)
- Hypertension(3 months)
- Body Mass Index (BMI)(3 months)
- Cholesterol(3 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
A Research Study to Evaluate the Safety of NNC1679-0001 When Given to Healthy Participants and Participants With T2DMHealthy VolunteersDiabetes Mellitus, Type 2NCT07570992Novo Nordisk A/S58
招募中
Phase 3 4
A study comparing Vitamin B2 with a dummy pillCTRI/2026/03/105920AlfiyaTahreen80
尚未招募
不适用
A Clinical Study to Assess the Safety and Benefits of Pistamel™ for Stress Reduction and Better Sleep in Adults.CTRI/2026/01/101314Botanic Healthcare Pvt. Ltd40
已完成
不适用
Safety and Efficacy of Tripalmitoleoylglycerol in the Treatment of DermatitisNCT07366255Shenzhen People's Hospital46
尚未招募
Phase 3 4
A Clinical Study to Evaluate the effect of F-Biotic in Type 2 Diabetes Mellitus Subjects.CTRI/2024/03/063627Arishina Life Sciences Pvt. Ltd.70