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Completed

NCT Number: NCT02961972

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy vegetarians of the vegan type

Exclusion criteria

  • previous treatment with dietary supplements
  • high intensity physical activity

Treatment and study plan

monohydrate and micronized creatine

Dietary Supplement

oral supplementation with creatine

Placebo

Other

oral supplementation with maltodextrin (control group)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute of Cardiology, Laranjeiras, Brazil

Other Gov

Registry information

Official study title

Effects of Oral Supplementation With Creatine on Plasma Homocysteine Levels and Systemic Microvascular Endothelial Function in Vegetarian Individuals

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2016
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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