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Completed

NCT Number: NCT03411369

Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in 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.

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Key information

Conditions

Ischemic Heart Disease Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine, D-Ribose, B1 Vitamin, and B6 vitamin

Dietary Supplement

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

Other

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

Primary outcomes

  1. Blood glucose

    Time frame: Change from Baseline at 6 months

    mg/dl

  2. Total cholesterol

    Time frame: Change from Baseline at 6 months

    mg/dl

  3. LDL-cholesterol

    Time frame: Change from Baseline at 6 months

    mg/dl

  4. HDL-cholesterol

    Time frame: Change from Baseline at 6 months

    mg/dl

  5. Triglycerides

    Time frame: Change from Baseline at 6 months

    mg/dl

  6. Creatinine

    Time frame: Change from Baseline at 6 months

    mg/dl

  7. Alanine transaminase

    Time frame: Change from Baseline at 6 months

    UI/l

  8. Water composition

    Time frame: Change from Baseline at 6 months

    Percentage

  9. Fat mass

    Time frame: Change from Baseline at 6 months

    Percentage

  10. Free fat mass

    Time frame: Change from Baseline at 6 months

    Percentage

  11. Chronotropic index

    Time frame: Change from Baseline at 6 months

    bpm

  12. 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 outcomes

  1. Body Mass Index

    Time frame: Change from Baseline at 6 months

    Kg/m2

  2. Systolic Blood Pressure

    Time frame: Change from Baseline at 6 months

    mmHg

  3. Heart Rate

    Time frame: Change from Baseline at 6 months

    bpm

Sponsors and collaborators

Lead sponsor

University of Pavia

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 26, 2018
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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