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

NCT04278378 | Completed

• 1 other identifier: REC/11/0081
• Study Type: interventional
• Target: 2,564
• Locations: 1 country
• Sites: 1

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) causes 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 an 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 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 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 infromation and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.

Conditions

Blood Pressure

Keywords

Blood pressure; Central hemodynamics; Methylenetetrahydrofolate reductase (MTHFR); Folate polymorphism; Riboflavin; Folic acid

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  Office blood pressure

  Change from baseline to 24 weeks

Secondary Outcomes (7)

• Central blood pressure

  Change from baseline to 24 weeks

• Pulse wave analysis

  Change from baseline to 24 weeks

• Pulse wave velocity

  Change from baseline to 24 weeks

• Red blood cell riboflavin

  Change from baseline to 24 weeks

• Red blood cell folate

  Change from baseline to 24 weeks

Study Arms (4)

Riboflavin

ACTIVE COMPARATOR

1.6 mg riboflavin / day for 24 weeks

Dietary Supplement: Riboflavin

Folic Acid

EXPERIMENTAL

0.4 mg folic acid/ day for 24 weeks

Dietary Supplement: Folic acid

Riboflavin + Folic Acid

EXPERIMENTAL

1.6mg Riboflavin + 0.4 mg Folic Acid / day for 24 weeks

Dietary Supplement: Riboflavin; Dietary Supplement: Folic acid

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Riboflavin DIETARY_SUPPLEMENT

1.6 mg riboflavin / day for 24 weeks

Riboflavin; Riboflavin + Folic Acid

Folic acid DIETARY_SUPPLEMENT

0.4 mg folic acid / day for 24 weeks

Folic Acid; Riboflavin + Folic Acid

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MTHFR 677TT genotype, aged at least 18 years old

You may not qualify if:

• Taking supplements containing B-vitamins
• Pregnant or planning to conceive
• Taking medications interfering with folate metabolism
• Renal or gastrointestinal disease

Sponsors & Collaborators

• University of Ulster: lead

Study Sites (1)

Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, BT52 1SA, United Kingdom

Location

MeSH Terms

Interventions

Riboflavin; Folic Acid

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Pterins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 20, 2020
• Study Start: June 28, 2011
• Primary Completion: August 15, 2019
• Study Completion: August 15, 2019
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)