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

Primary Purpose

Ischemic Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
Placebo
Sponsored by
University of Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ischemic Heart Disease focused on measuring Creatine, ribose, ischemic heart disease.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

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

    Placebo

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Body Mass Index
    Kg/m2
    Systolic Blood Pressure
    mmHg
    Heart Rate
    bpm

    Full Information

    First Posted
    January 10, 2018
    Last Updated
    January 29, 2018
    Sponsor
    University of Pavia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03411369
    Brief Title
    Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (Actual)
    Primary Completion Date
    June 1, 2017 (Actual)
    Study Completion Date
    November 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Pavia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ischemic Heart Disease
    Keywords
    Creatine, ribose, ischemic heart disease.

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
    Masking
    ParticipantInvestigator
    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.
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
    Other Intervention Name(s)
    Crebox
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.
    Primary Outcome Measure Information:
    Title
    Blood glucose
    Description
    mg/dl
    Time Frame
    Change from Baseline at 6 months
    Title
    Total cholesterol
    Description
    mg/dl
    Time Frame
    Change from Baseline at 6 months
    Title
    LDL-cholesterol
    Description
    mg/dl
    Time Frame
    Change from Baseline at 6 months
    Title
    HDL-cholesterol
    Description
    mg/dl
    Time Frame
    Change from Baseline at 6 months
    Title
    Triglycerides
    Description
    mg/dl
    Time Frame
    Change from Baseline at 6 months
    Title
    Creatinine
    Description
    mg/dl
    Time Frame
    Change from Baseline at 6 months
    Title
    Alanine transaminase
    Description
    UI/l
    Time Frame
    Change from Baseline at 6 months
    Title
    Water composition
    Description
    Percentage
    Time Frame
    Change from Baseline at 6 months
    Title
    Fat mass
    Description
    Percentage
    Time Frame
    Change from Baseline at 6 months
    Title
    Free fat mass
    Description
    Percentage
    Time Frame
    Change from Baseline at 6 months
    Title
    Chronotropic index
    Description
    bpm
    Time Frame
    Change from Baseline at 6 months
    Title
    Cardiac double product at the peak of the load
    Description
    It will be calculated by multiplying systolic blood pressure and heart rate
    Time Frame
    Change from Baseline at 6 months
    Secondary Outcome Measure Information:
    Title
    Body Mass Index
    Description
    Kg/m2
    Time Frame
    Change from Baseline at 6 months
    Title
    Systolic Blood Pressure
    Description
    mmHg
    Time Frame
    Change from Baseline at 6 months
    Title
    Heart Rate
    Description
    bpm
    Time Frame
    Change from Baseline at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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