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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 1, 2017

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Body Mass Index
    • Time Frame: Change from Baseline at 6 months
    • Kg/m2
  • Systolic Blood Pressure
    • Time Frame: Change from Baseline at 6 months
    • mmHg
  • Heart Rate
    • Time Frame: Change from Baseline at 6 months
    • bpm

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Pavia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Giuseppe Derosa, Principal Investigator – University of Pavia

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