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
About this trial
This is an interventional other trial for Ischemic Heart Disease focused on measuring Creatine, ribose, ischemic heart disease.
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
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
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
Learn more about this trial
Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
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