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

NCT03411369 | Completed

• 1 other identifier: 23473
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ischemic Heart Disease

Keywords

Creatine, ribose, ischemic heart disease.

Outcome Measures

Primary Outcomes (12)

• Blood glucose

  mg/dl

  Change from Baseline at 6 months

• Total cholesterol

  mg/dl

  Change from Baseline at 6 months

• LDL-cholesterol

  mg/dl

  Change from Baseline at 6 months

• HDL-cholesterol

  mg/dl

  Change from Baseline at 6 months

• Triglycerides

  mg/dl

  Change from Baseline at 6 months

• Creatinine

  mg/dl

  Change from Baseline at 6 months

• Alanine transaminase

  UI/l

  Change from Baseline at 6 months

• Water composition

  Percentage

  Change from Baseline at 6 months

• Fat mass

  Percentage

  Change from Baseline at 6 months

• Free fat mass

  Percentage

  Change from Baseline at 6 months

• Chronotropic index

  bpm

  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

  Change from Baseline at 6 months

Secondary Outcomes (3)

• Body Mass Index

  Change from Baseline at 6 months

• Systolic Blood Pressure

  Change from Baseline at 6 months

• Heart Rate

  Change from Baseline at 6 months

Study Arms (2)

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.

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.

Other: Placebo

Interventions

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

Also known as: Crebox

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

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presented acute coronary syndrome treated with at least 30 days by hospital discharge

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: lead

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Creatine; Ribose; Thiamine; Vitamin B 6

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Pentoses; Monosaccharides; Sugars; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Picolines; Pyridines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups, one receiving treatment (Creatine, D-Ribose, B1 Vitamin, and B6 vitamin), and one receiving placebo.

Study Record Dates

• First Submitted: January 10, 2018
• First Posted: January 26, 2018
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: November 15, 2017
• Last Updated: January 31, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share