Clinical trial NCT03411369: Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Creatine, ribose, ischemic heart disease.
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose
timeFrame: Change from Baseline at 6 months
measure: Total cholesterol
timeFrame: Change from Baseline at 6 months
measure: LDL-cholesterol
timeFrame: Change from Baseline at 6 months
measure: HDL-cholesterol
timeFrame: Change from Baseline at 6 months
measure: Triglycerides
timeFrame: Change from Baseline at 6 months
measure: Creatinine
timeFrame: Change from Baseline at 6 months
measure: Alanine transaminase
timeFrame: Change from Baseline at 6 months
measure: Water composition
timeFrame: Change from Baseline at 6 months
measure: Fat mass
timeFrame: Change from Baseline at 6 months
measure: Free fat mass
timeFrame: Change from Baseline at 6 months
measure: Chronotropic index
timeFrame: Change from Baseline at 6 months
measure: Cardiac double product at the peak of the load
timeFrame: Change from Baseline at 6 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Change from Baseline at 6 months
measure: Systolic Blood Pressure
timeFrame: Change from Baseline at 6 months
measure: Heart Rate
timeFrame: Change from Baseline at 6 months
Other outcomes:
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Study officials:
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