NCT02961972

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

2.4 years

First QC Date

November 7, 2016

Last Update Submit

July 27, 2017

Conditions

Endothelial DysfunctionHyperhomocysteinemia

Keywords

vegetarianismHyperhomocysteinemiavegan vegetarian

Outcome Measures

Primary Outcomes (1)

  • Reactivity of the systemic microcirculation

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

    three-week treatment

Secondary Outcomes (2)

  • cutaneous microvascular density

    three-week treatment

  • Homocysteine levels in the plasma

    three-week treatment

Study Arms (2)

control group

PLACEBO COMPARATOR

Oral ingestion of placebo pills (maltodextrin) during three weeks

Other: placebo

creatine supplementation

EXPERIMENTAL

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

Dietary Supplement: monohydrate and micronized creatine

Interventions

monohydrate and micronized creatineDIETARY_SUPPLEMENT

oral supplementation with creatine

creatine supplementation
placeboOTHER

oral supplementation with maltodextrin (control group)

control group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy vegetarians of the vegan type

You may not qualify if:

  • previous treatment with dietary supplements
  • high intensity physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

MeSH Terms

Conditions

Hyperhomocysteinemia

Condition Hierarchy (Ancestors)

Amino Acid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMalabsorption SyndromesMetabolic DiseasesNutritional and Metabolic DiseasesVitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Study Officials

  • Eduardo Tibirica, MD, PhD

    National Institute of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
creatine or placebo supplementation
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: creatine or placebo supplementation
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 11, 2016

Study Start

January 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)