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Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals

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ClinicalTrials.gov Identifier: NCT02961972
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Eduardo Tibirica, National Institute of Cardiology, Laranjeiras, Brazil

Brief Summary:
The present study aims at investigating the effects of the oral supplementation with creatine on the systemic microvascular reactivity and plasma levels of homocysteine in vegetarian individuals of the vegan type.

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Hyperhomocysteinemia Dietary Supplement: monohydrate and micronized creatine Other: placebo Not Applicable

Detailed Description:

A vegetarian is an individual who lives on a diet of grains, pulses, legumes, nuts, seeds, vegetables, fruits, fungi, algae, yeast and/or some other non-animal-based foods, with or without, dairy products, honey and/or eggs. A vegetarian does not eat foods that consist of, or have been produced with the aid of products consisting of or created from, any part of the body of a living or dead animal. This includes meat, poultry, fish, shellfish, insects, by-products of slaughter** or any food made with processing aids created from these.

There are different types of vegetarian: i) Lacto-ovo-vegetarians eat both dairy products and eggs; this is the most common type of vegetarian diet; ii) Lacto-vegetarians eat dairy products but avoid eggs; iii) Ovo-vegetarians eat eggs but not dairy products; iv) Vegans do not eat dairy products, eggs, or any other products which are derived from animals.

Vegetarian individuals are considered to have lower cardiovascular risk for the development of cardiovascular diseases and lower cardiovascular mortality, when compared to omnivore individuals.

Nevertheless, some vegetarian diets may result in the deficiency of micronutrients and induce deficiency in some compounds such as vitamins, amino-acids, iron, zinc, calcium, omega-3 fatty acids and so on.

Moreover, vegetarian individuals can present deficiency in amino-acids such as carnosine and creatine, present essentially in the skeletal muscle of animals. In this context, deficiency in creatine has been considered as a risk factor for hyperhomocysteinemia and the consequent dysfunction of the vascular endothelium.

Hyperhomocysteinemia also is known to be an independent risk factor for cardiovascular diseases similar to hypertension, smoke and dyslipidemia.

In the present study, we investigate the effects of creatine supplementation in the systemic microvascular endothelial function and density in vegan-vegetarians presenting with normo- or hyperhomocysteinemia using laser-based skin flowmetry and video-capillaroscopy. We also investigate the effects of creatine supplementation on lipid and glycemic profile and plasma homocysteine levels.

Microvascular reactivity is evaluated using a laser speckle contrast imaging system in combination with the iontophoresis of acetylcholine (ACh), for the noninvasive and continuous measurement of cutaneous microvascular perfusion changes.

Microvascular density in the skin is evaluated using intravital video-microscopy.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: creatine or placebo supplementation
Masking: Single (Participant)
Masking Description: creatine or placebo supplementation
Primary Purpose: Treatment
Official Title: Effects of Oral Supplementation With Creatine on Plasma Homocysteine Levels and Systemic Microvascular Endothelial Function in Vegetarian Individuals
Study Start Date : January 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
Placebo Comparator: control group
Oral ingestion of placebo pills (maltodextrin) during three weeks
Other: placebo
oral supplementation with maltodextrin (control group)
Experimental: creatine supplementation
Oral supplementation with 5 g of monohydrate and micronized creatine during three weeks
Dietary Supplement: monohydrate and micronized creatine
oral supplementation with creatine



Primary Outcome Measures :
  1. Reactivity of the systemic microcirculation [ Time Frame: three-week treatment ]
    Assessment of the endothelial-dependent microvascular reactivity in the skin using laser speckle contrast imaging


Secondary Outcome Measures :
  1. cutaneous microvascular density [ Time Frame: three-week treatment ]
    Assessment of skin microvascular density using video-capillaroscopy

  2. Homocysteine levels in the plasma [ Time Frame: three-week treatment ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy vegetarians of the vegan type

Exclusion Criteria:

  • previous treatment with dietary supplements
  • high intensity physical activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02961972


Locations
Brazil
National Institute of Cardiology, Ministry of Health, Brazil
Rio de Janeiro, Brazil, 22240-006
Sponsors and Collaborators
National Institute of Cardiology, Laranjeiras, Brazil
Investigators
Principal Investigator: Eduardo Tibirica, MD, PhD National Institute of Cardiology

Responsible Party: Eduardo Tibirica, MD, PhD, National Institute of Cardiology, Laranjeiras, Brazil
ClinicalTrials.gov Identifier: NCT02961972     History of Changes
Other Study ID Numbers: CAAE: 302471512.4.0000.5272
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Eduardo Tibirica, National Institute of Cardiology, Laranjeiras, Brazil:
vegetarianism
Hyperhomocysteinemia
vegan vegetarian

Additional relevant MeSH terms:
Amino Acid Metabolism, Inborn Errors
Hyperhomocysteinemia
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Malabsorption Syndromes
Metabolic Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders