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Trial record 25 of 16921 for:    "Heart Diseases"

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

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ClinicalTrials.gov Identifier: NCT03411369
Recruitment Status : Completed
First Posted : January 26, 2018
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Giuseppe Derosa, University of Pavia

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.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Dietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
Masking: Double (Participant, Investigator)
Masking Description: Double blind study design. The dietary supplement of Creatine, D-Ribose, B1 Vitamin, and B6 vitamin will come in the form of 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. The same administration will come for placebo group with the inert product sachets consisting of starch powder.
Primary Purpose: Other
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
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : June 1, 2017
Actual Study Completion Date : November 15, 2017


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 Name: 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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Giuseppe Derosa, Principal Investigator, University of Pavia
ClinicalTrials.gov Identifier: NCT03411369     History of Changes
Other Study ID Numbers: 23473
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giuseppe Derosa, University of Pavia:
Creatine, ribose, ischemic heart disease.

Additional relevant MeSH terms:
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Heart Diseases
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Vitamins
Pyridoxine
Vitamin B 6
Thiamine
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex