Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02961972|
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : July 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Endothelial Dysfunction Hyperhomocysteinemia||Dietary Supplement: monohydrate and micronized creatine Other: placebo||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||creatine or placebo supplementation|
|Masking Description:||creatine or placebo supplementation|
|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|
Placebo Comparator: control group
Oral ingestion of placebo pills (maltodextrin) during three weeks
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
- 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
- cutaneous microvascular density [ Time Frame: three-week treatment ]Assessment of skin microvascular density using video-capillaroscopy
- Homocysteine levels in the plasma [ Time Frame: three-week treatment ]
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
|National Institute of Cardiology, Ministry of Health, Brazil|
|Rio de Janeiro, Brazil, 22240-006|
|Principal Investigator:||Eduardo Tibirica, MD, PhD||National Institute of Cardiology|