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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02961972
Other study ID # CAAE: 302471512.4.0000.5272
Secondary ID
Status Completed
Phase N/A
First received November 7, 2016
Last updated July 27, 2017
Start date January 2015
Est. completion date June 2017

Study information

Verified date July 2017
Source National Institute of Cardiology, Laranjeiras, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date June 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- healthy vegetarians of the vegan type

Exclusion Criteria:

- previous treatment with dietary supplements

- high intensity physical activity

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
monohydrate and micronized creatine
oral supplementation with creatine
Other:
placebo
oral supplementation with maltodextrin (control group)

Locations

Country Name City State
Brazil National Institute of Cardiology, Ministry of Health, Brazil Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Cardiology, Laranjeiras, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reactivity of the systemic microcirculation Assessment of the endothelial-dependent microvascular reactivity in the skin using laser speckle contrast imaging three-week treatment
Secondary cutaneous microvascular density Assessment of skin microvascular density using video-capillaroscopy three-week treatment
Secondary Homocysteine levels in the plasma three-week treatment
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