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

Blood Pressure Clinical Trial

— RAFA Obs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948086
• Other study ID #: REC/11/0081 Obs
• Status: Completed
• Start date: June 28, 2011
• Est. completion date: August 15, 2019

Study information

• Verified date: June 2021
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: August 15, 2019
• Est. primary completion date: August 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pre-screened for MTHFR 677TT genotype

• Aged at least 18 years old

Exclusion Criteria:

• Younger than 18 years

• Pregnant

Related Conditions & MeSH terms

• Blood Pressure

Locations

Country	Name	City	State
United Kingdom	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulster

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Office blood pressure	One day, one measurement
Secondary	Brachial blood pressure	Measured using SphygmoCor device	One day, one measurement
Secondary	Central blood pressure	Measured using SphygmoCor device	One day, one measurement
Secondary	Pulse wave analysis	Measured using SphygmoCor device	One day, one measurement
Secondary	Pulse wave velocity	Measured using SphygmoCor device	One day, one measurement
Secondary	Riboflavin status	Measured by by EGRac	One day, one measurement
Secondary	Folate status	Measured by microbiological assay	One day, one measurement
Secondary	PLP status	Measured by HPLC	One day, one measurement
Secondary	Homocysteine status	Measured by GCMS	One day, one measurement
Secondary	One-carbon metabolite status	Measured by GCMS-MS	One day, one measurement