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

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Dietary supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin; 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.; Other Names: Crebox
Placebo Comparator: Placebo; Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.	Other: Placebo; Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pavia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): November 15, 2017

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Creatine, ribose, ischemic heart disease.
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 23473

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No