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

Effects of Oral Supplementation With Creatine on Plasma Homocysteine Levels and 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.

Study Overview

• Status: Completed
• Conditions: Endothelial Dysfunction; Hyperhomocysteinemia
• Intervention / Treatment: Other: placebo; Dietary supplement: monohydrate and micronized creatine

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
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 22240-006
    • National Institute of Cardiology, Ministry of Health, Brazil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy vegetarians of the vegan type

Exclusion Criteria:

• previous treatment with dietary supplements
• high intensity physical activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reactivity of the systemic microcirculation	Assessment of the endothelial-dependent microvascular reactivity in the skin using laser speckle contrast imaging	three-week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cutaneous microvascular density	Assessment of skin microvascular density using video-capillaroscopy	three-week treatment
Homocysteine levels in the plasma		three-week treatment

Collaborators and Investigators

• Sponsor: National Institute of Cardiology, Laranjeiras, Brazil

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): June 1, 2017
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 9, 2016
• First Posted (ESTIMATE): November 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Hyperhomocysteinemia; vegetarianism; vegan vegetarian
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutrition Disorders; Genetic Diseases, Inborn; Avitaminosis; Deficiency Diseases; Malnutrition; Metabolism, Inborn Errors; Malabsorption Syndromes; Amino Acid Metabolism, Inborn Errors; Vitamin B Deficiency; Hyperhomocysteinemia
• Other Study ID Numbers: CAAE: 302471512.4.0000.5272

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO