A Randomized, Double Blind, Placebo Controlled Study To Evaluate The Effectiveness Of A Food Supplement Containing Creatine And D-Ribose In Increasing Stress Tolerance In Patients With Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- Creatinine
研究概览
简要总结
Recently, researchers have paid attention to the development of new products such as supplements food and nutraceuticals for identify and develop integrative therapies to be used in cardiovascular disease. As suggested by literature, some nutritional components (creatine, ribose) can enhance the fundamental energy levels for the functioning of the heart muscle and can enhance the body's antioxidant capacity through the reduction in free radicals activity, one of the main pathogenic mechanisms of these diseases. In this context, the investigators have developed a research with the principal purpose to establish whether a supplement of creatine and ribose can improve the total work capacity during exercise in a population of patients with known ischemic heart disease.
详细描述
The investigators will enroll patients with previous acute coronary syndrome treated for at least 30 days by hospital discharge. The treatment regimen of all patients will be optimized in accordance with European Society of Cardiology guidelines. Standardized pharmacological treatment during cardiac rehabilitation period will include administration of angiotensin converting enzyme inhibition (ACE), beta-blockers and antiplatelet blockers. Furthermore, in order to keep patients free from angina symptoms, in some cases calcium channel blockers and/or nitrates will be used. The investigators will randomize participants into two groups, one receiving treatment Creatine, D-Ribose, B1 Vitamin, and B6 vitamin, and one receiving placebo in a double blind study design, for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind study design. The dietary supplement of Creatine, D-Ribose, B1 Vitamin, and B6 vitamin will come in the form of water-soluble powder in sachets of 4 grams. Each sachet contains 1 gram of Creatine, 2.5 grams of D-Ribose, 0.33 mg of B1 vitamin and 0.42 mg of B6 vitamin. The same administration will come for placebo group with the inert product sachets consisting of starch powder.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge
排除标准
- •oncological diseases
- •stable atrial fibrillation
- •stent in the common core
- •patients who are not able to perform physical activities
- •patients with documented sustained ventricular arrhythmias
- •pregnant women
研究组 & 干预措施
Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
Water-soluble powder in sachets of 4 grams. Each sachet contains 1 gram of Creatine, 2.5 grams of D-Ribose, 0.33 mg of B1 vitamin and 0.42 mg of B6 vitamin.
干预措施: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin (Dietary Supplement)
Placebo
Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.
干预措施: Placebo (Other)
结局指标
主要结局
Creatinine
时间窗: Change from Baseline at 6 months
mg/dl
Triglycerides
时间窗: Change from Baseline at 6 months
mg/dl
Free fat mass
时间窗: Change from Baseline at 6 months
Percentage
Cardiac double product at the peak of the load
时间窗: Change from Baseline at 6 months
It will be calculated by multiplying systolic blood pressure and heart rate
LDL-cholesterol
时间窗: Change from Baseline at 6 months
mg/dl
Total cholesterol
时间窗: Change from Baseline at 6 months
mg/dl
HDL-cholesterol
时间窗: Change from Baseline at 6 months
mg/dl
Fat mass
时间窗: Change from Baseline at 6 months
Percentage
Alanine transaminase
时间窗: Change from Baseline at 6 months
UI/l
Water composition
时间窗: Change from Baseline at 6 months
Percentage
Blood glucose
时间窗: Change from Baseline at 6 months
mg/dl
Chronotropic index
时间窗: Change from Baseline at 6 months
bpm
次要结局
- Systolic Blood Pressure(Change from Baseline at 6 months)
- Heart Rate(Change from Baseline at 6 months)
- Body Mass Index(Change from Baseline at 6 months)
研究者
Giuseppe Derosa
Principal Investigator
University of Pavia