Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Dietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin<br>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. | Dietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin<br>* The treatment will consist of taking 2 sachets / day for the first two weeks, and then continuing with 1 sachet/day for the next month.<br>* Other names: Crebox;|
| Placebo Comparator: Placebo<br>Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder. | Other: Placebo<br>* Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood glucose | mg/dl | Change from Baseline at 6 months | 
| Total cholesterol | mg/dl | Change from Baseline at 6 months | 
| LDL-cholesterol | mg/dl | Change from Baseline at 6 months | 
| HDL-cholesterol | mg/dl | Change from Baseline at 6 months | 
| Triglycerides | mg/dl | Change from Baseline at 6 months | 
| Creatinine | mg/dl | Change from Baseline at 6 months | 
| Alanine transaminase | UI/l | Change from Baseline at 6 months | 
| Water composition | Percentage | Change from Baseline at 6 months | 
| Fat mass | Percentage | Change from Baseline at 6 months | 
| Free fat mass | Percentage | Change from Baseline at 6 months | 
| Chronotropic index | bpm | Change from Baseline at 6 months | 
| Cardiac double product at the peak of the load | It will be calculated by multiplying systolic blood pressure and heart rate | Change from Baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | Kg/m2 | Change from Baseline at 6 months | 
| Systolic Blood Pressure | mmHg | Change from Baseline at 6 months | 
| Heart Rate | bpm | Change from Baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Creatine, ribose, ischemic heart disease.