Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
- Conditions
- Ischemic Heart Disease
- Interventions
- Other: PlaceboDietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
- Registration Number
- NCT03411369
- Lead Sponsor
- University of Pavia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
- All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder. Creatine, D-Ribose, B1 Vitamin, and B6 vitamin 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.
- Primary Outcome Measures
Name Time Method Creatinine Change from Baseline at 6 months mg/dl
Alanine transaminase Change from Baseline at 6 months UI/l
Water composition Change from Baseline at 6 months Percentage
Triglycerides Change from Baseline at 6 months mg/dl
Free fat mass Change from Baseline at 6 months Percentage
Cardiac double product at the peak of the load Change from Baseline at 6 months It will be calculated by multiplying systolic blood pressure and heart rate
LDL-cholesterol Change from Baseline at 6 months mg/dl
Total cholesterol Change from Baseline at 6 months mg/dl
HDL-cholesterol Change from Baseline at 6 months mg/dl
Fat mass Change from Baseline at 6 months Percentage
Blood glucose Change from Baseline at 6 months mg/dl
Chronotropic index Change from Baseline at 6 months bpm
- Secondary Outcome Measures
Name Time Method Heart Rate Change from Baseline at 6 months bpm
Systolic Blood Pressure Change from Baseline at 6 months mmHg
Body Mass Index Change from Baseline at 6 months Kg/m2