Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals
Primary Purpose
Endothelial Dysfunction, Hyperhomocysteinemia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
monohydrate and micronized creatine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Endothelial Dysfunction focused on measuring vegetarianism, Hyperhomocysteinemia, vegan vegetarian
Eligibility Criteria
Inclusion Criteria:
- healthy vegetarians of the vegan type
Exclusion Criteria:
- previous treatment with dietary supplements
- high intensity physical activity
Sites / Locations
- National Institute of Cardiology, Ministry of Health, Brazil
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control group
creatine supplementation
Arm Description
Oral ingestion of placebo pills (maltodextrin) during three weeks
Oral supplementation with 5 g of monohydrate and micronized creatine during three weeks
Outcomes
Primary Outcome Measures
Reactivity of the systemic microcirculation
Assessment of the endothelial-dependent microvascular reactivity in the skin using laser speckle contrast imaging
Secondary Outcome Measures
cutaneous microvascular density
Assessment of skin microvascular density using video-capillaroscopy
Homocysteine levels in the plasma
Full Information
NCT ID
NCT02961972
First Posted
November 7, 2016
Last Updated
July 27, 2017
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
1. Study Identification
Unique Protocol Identification Number
NCT02961972
Brief Title
Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals
Official Title
Effects of Oral Supplementation With Creatine on Plasma Homocysteine Levels and Systemic Microvascular Endothelial Function in Vegetarian Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Hyperhomocysteinemia
Keywords
vegetarianism, Hyperhomocysteinemia, vegan vegetarian
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
creatine or placebo supplementation
Masking
Participant
Masking Description
creatine or placebo supplementation
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Oral ingestion of placebo pills (maltodextrin) during three weeks
Arm Title
creatine supplementation
Arm Type
Experimental
Arm Description
Oral supplementation with 5 g of monohydrate and micronized creatine during three weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
monohydrate and micronized creatine
Intervention Description
oral supplementation with creatine
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
oral supplementation with maltodextrin (control group)
Primary Outcome Measure Information:
Title
Reactivity of the systemic microcirculation
Description
Assessment of the endothelial-dependent microvascular reactivity in the skin using laser speckle contrast imaging
Time Frame
three-week treatment
Secondary Outcome Measure Information:
Title
cutaneous microvascular density
Description
Assessment of skin microvascular density using video-capillaroscopy
Time Frame
three-week treatment
Title
Homocysteine levels in the plasma
Time Frame
three-week treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy vegetarians of the vegan type
Exclusion Criteria:
previous treatment with dietary supplements
high intensity physical activity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Tibirica, MD, PhD
Organizational Affiliation
National Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cardiology, Ministry of Health, Brazil
City
Rio de Janeiro
ZIP/Postal Code
22240-006
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of Oral Supplementation With Creatine on Systemic Microvascular Endothelial Function in Vegetarian Individuals
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