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

NCT ID: NCT03411369

Last Updated: 2018-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-11-15

Brief Summary

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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

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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

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Ischemic Heart Disease

Keywords

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Creatine, ribose, ischemic heart disease.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Crebox

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pavia

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Derosa

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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23473

Identifier Type: -

Identifier Source: org_study_id