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

Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411369
• Other study ID #: 23473
• Status: Completed
• Phase: N/A
• First received: January 10, 2018
• Last updated: January 29, 2018
• Start date: June 1, 2016
• Est. completion date: November 15, 2017

Study information

• Verified date: January 2018
• Source: University of Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 15, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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:
• Placebo
Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pavia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose	mg/dl	Change from Baseline at 6 months
Primary	Total cholesterol	mg/dl	Change from Baseline at 6 months
Primary	LDL-cholesterol	mg/dl	Change from Baseline at 6 months
Primary	HDL-cholesterol	mg/dl	Change from Baseline at 6 months
Primary	Triglycerides	mg/dl	Change from Baseline at 6 months
Primary	Creatinine	mg/dl	Change from Baseline at 6 months
Primary	Alanine transaminase	UI/l	Change from Baseline at 6 months
Primary	Water composition	Percentage	Change from Baseline at 6 months
Primary	Fat mass	Percentage	Change from Baseline at 6 months
Primary	Free fat mass	Percentage	Change from Baseline at 6 months
Primary	Chronotropic index	bpm	Change from Baseline at 6 months
Primary	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	Body Mass Index	Kg/m2	Change from Baseline at 6 months
Secondary	Systolic Blood Pressure	mmHg	Change from Baseline at 6 months
Secondary	Heart Rate	bpm	Change from Baseline at 6 months