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临床试验/NCT02961972
NCT02961972已完成不适用

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

National Institute of Cardiology, Laranjeiras, Brazil2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
49
试验地点
2
主要终点
Reactivity of the systemic microcirculation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

creatine or placebo supplementation

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • healthy vegetarians of the vegan type

排除标准

  • previous treatment with dietary supplements
  • high intensity physical activity

研究组 & 干预措施

control group

Placebo Comparator

Oral ingestion of placebo pills (maltodextrin) during three weeks

干预措施: placebo (Other)

creatine supplementation

Experimental

Oral supplementation with 5 g of monohydrate and micronized creatine during three weeks

干预措施: monohydrate and micronized creatine (Dietary Supplement)

结局指标

主要结局

Reactivity of the systemic microcirculation

时间窗: three-week treatment

Assessment of the endothelial-dependent microvascular reactivity in the skin using laser speckle contrast imaging

次要结局

  • cutaneous microvascular density(three-week treatment)
  • Homocysteine levels in the plasma(three-week treatment)

研究者

发起方
National Institute of Cardiology, Laranjeiras, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eduardo Tibirica

MD, PhD

National Institute of Cardiology, Laranjeiras, Brazil

研究点 (2)

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