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Blood Pressure and Central Haemodynamics in Healthy Adults Stratified by MTHFR Genotype

Blood Pressure Lowering Effect of B-vitamins in Adults With a Genetic Pre-disposition to Elevated Blood Pressure.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04948086
Acronym
RAFA Obs
Enrollment
498
Registered
2021-07-01
Start date
2011-06-28
Completion date
2019-08-15
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Keywords

Blood Pressure, MTHFR, Methylenetetrahydrofolate Reductase, Central Hemodynamics, Riboflavin, Folic Acid, Folate Polymorphism

Brief summary

Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Homozygosity for the polymorphism (TT genotype) appears to result in an increased requirement for the B-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (BP). Previous work from our Centre has demonstrated significantly higher BP in those with the TT genotype. This work has been conducted in cohorts with premature cardiovascular disease (CVD) and hypertension without overt CVD, but the effect in younger, healthier individuals is unexplored. To date our studies have also focused on BP as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of CVD. The effect of the TT genotype on these measures is thus an important area for investigation and may help us understand the mechanism linking the genotype with BP, which is currently unknown. As adults with the TT genotype appear to have increased requirements for riboflavin and folic acid, and BP in TT adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. Study Design This is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by MTHFR genotype. Apparently healthy adults will be recruited from workplaces and the general community across Northern Ireland and screened for the polymorphism via buccal swab. Those with the TT genotype and a similar number of non-TT (i.e. CC/CT) genotype individuals will be contacted and asked to come to attend a one-off appointment. Brachial BP will be assessed by an electronic BP monitor, central BP and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by SphygmoCor XCEL. In addition, anthropometric measurements, health and lifestyle information and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.

Interventions

None listed

Sponsors

University of Ulster
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Pre-screened for MTHFR 677TT genotype * Aged at least 18 years old

Exclusion criteria

* Younger than 18 years * Pregnant

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureOne day, one measurementOffice blood pressure

Secondary

MeasureTime frameDescription
Brachial blood pressureOne day, one measurementMeasured using SphygmoCor device
Central blood pressureOne day, one measurementMeasured using SphygmoCor device
Pulse wave analysisOne day, one measurementMeasured using SphygmoCor device
Pulse wave velocityOne day, one measurementMeasured using SphygmoCor device
One-carbon metabolite statusOne day, one measurementMeasured by GCMS-MS
Folate statusOne day, one measurementMeasured by microbiological assay
PLP statusOne day, one measurementMeasured by HPLC
Homocysteine statusOne day, one measurementMeasured by GCMS
Riboflavin statusOne day, one measurementMeasured by by EGRac

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026