Ischemic Heart DiseaseNCT03411369
Creatine, D-Ribose, B1 Vitamin, and B6 Vitamin in Ischemic Heart Disease
A study testing Creatine, D-Ribose, B1 Vitamin, and B6 vitamin in people with Ischemic Heart Disease, run by University of Pavia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Creatine, D-Ribose, B1 Vitamin, and B6 vitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 15 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge
Who cannot join
- 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
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Creatine, D-Ribose, B1 Vitamin, and B6 vitamin, Placebo
- Keywords
- Creatine, ribose, ischemic heart disease.
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine, D-Ribose, B1 Vitamin, and B6 vitaminDietary supplement
Also called Crebox
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.
PlaceboOther
Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.
| Study group | Role | What they receive |
|---|---|---|
| Creatine, D-Ribose, B1 Vitamin, and B6 vitamin | Experimental | 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. Receives: Dietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitamin |
| Placebo | Placebo comparator | Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
mg/dl
Measured: Change from Baseline at 6 months
Total cholesterol
mg/dl
Measured: Change from Baseline at 6 months
LDL-cholesterol
mg/dl
Measured: Change from Baseline at 6 months
HDL-cholesterol
mg/dl
Measured: Change from Baseline at 6 months
Triglycerides
mg/dl
Measured: Change from Baseline at 6 months
Creatinine
mg/dl
Measured: Change from Baseline at 6 months
Alanine transaminase
UI/l
Measured: Change from Baseline at 6 months
Water composition
Percentage
Measured: Change from Baseline at 6 months
Fat mass
Percentage
Measured: Change from Baseline at 6 months
Free fat mass
Percentage
Measured: Change from Baseline at 6 months
Chronotropic index
bpm
Measured: Change from Baseline at 6 months
Cardiac double product at the peak of the load
It will be calculated by multiplying systolic blood pressure and heart rate
Measured: Change from Baseline at 6 months
Secondary outcomes (3)
Body Mass Index
Kg/m2
Measured: Change from Baseline at 6 months
Systolic Blood Pressure
mmHg
Measured: Change from Baseline at 6 months
Heart Rate
bpm
Measured: Change from Baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start1 Jun 2016
- Primary completion1 Jun 2017
- Study completion15 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411369
- Sponsor's protocol ID
- 23473
- Status last verified
- Jan 2018
- First submitted
- 10 Jan 2018
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03411369
- Acronym / sponsor ID
- 23473
- Conditions
- Ischemic Heart Disease
- Keywords
- Creatine, ribose, ischemic heart disease.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
| Arm | Type | Receives |
|---|---|---|
| Creatine, D-Ribose, B1 Vitamin, and B6 vitamin | Experimental | Dietary Supplement: Creatine, D-Ribose, B1 Vitamin, and B6 vitaminWater-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 | Placebo comparator | Other: PlaceboWater-soluble powder in sachets of 4 grams containing inert product consisting of starch powder. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine, D-Ribose, B1 Vitamin, and B6 vitaminAlso: CreboxThe treatment will consist of taking 2 sachets / day for the first two weeks, and then continuing with 1 sachet/day for the next month. | Dietary supplement | Creatine, D-Ribose, B1 Vitamin, and B6 vitamin |
| PlaceboWater-soluble powder in sachets of 4 grams containing inert product consisting of starch powder. | Other | Placebo |
Primary outcome
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
3 secondary outcomes
Body Mass Index
Time frame: Change from Baseline at 6 months
Systolic Blood Pressure
Time frame: Change from Baseline at 6 months
Heart Rate
Time frame: Change from Baseline at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Creatine, D-Ribose, B1 Vitamin, and B6 vitamin in people with Ischemic Heart Disease, run by University of Pavia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: Change from Baseline at 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.