Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults

Hypertension Clinical Trial

— InteRVENE  

Official title:

Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults (InteRVENE Study)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05488106
• Other study ID #: REC/19/0079
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2022
• Source: University of Ulster
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

High blood pressure is the leading risk factor for heart disease and stroke. Approximately 12% of the population have a particular genetic factor (known as the TT genotype) which increases the risk of high blood pressure. Previous studies conducted at this centre have shown that taking the B-vitamin riboflavin, for up to 3 months, decreases blood pressure in adults with the TT genotype. It is currently not known how riboflavin lowers blood pressure in those with the TT genotype but it could be as a result of altering blood levels of nitric oxide. Nitric oxide causes blood vessels to expand, leading to improved blood vessel function, an important predictor of cardiovascular health. However, the effect of riboflavin supplementation on nitric oxide and blood vessel function has not been previously studied. Furthermore, it is unclear whether taking riboflavin over a shorter period of time or at doses higher than 1.6 mg/d can also lower blood pressure and improve blood vessel function in this at risk group. Therefore, the aim of this study is to assess the effects of riboflavin supplementation on blood pressure, biomarkers of nitric oxide bioavailability and blood vessel function. It is hypothesised that riboflavin supplementation will increase nitric oxide bioavailability, leading to reduced blood pressure and improved blood vessel function and, and that a higher riboflavin dose will lead to greater reductions in blood pressure.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male

• Aged 60 years and below

• Pre-screened for MTHFR 677TT genotype (TTs and CCs individuals only invited)

Exclusion Criteria:

• Consumer of B-vitamin supplements

• Consuming medication that interferes with B-vitamin metabolism

Related Conditions & MeSH terms

• Blood Pressure
• Hypertension

Intervention

Dietary Supplement:
• Placebo
Placebo
• Riboflavin 1.6mg/d
Riboflavin 1.6mg/d
• Riboflavin 5mg/d
Riboflavin 5mg/d
• Riboflavin 20mg/d
Riboflavin 20mg/d

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulster	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Branchial blood pressure	Change over 16 weeks
Primary	Diastolic blood pressure	Branchial blood pressure	Change over 16 weeks
Secondary	Endothelial function	Measured by Flow Mediated Dilation	Change over 16 weeks
Secondary	Nitric oxide bioavailability	Plasma nitrite and nitrate oxide analysed by a Sievers gas-phase chemiluminescence nitric oxide analyser	Change over 16 weeks
Secondary	Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)	Measured on automatic analyser	Change over 16 weeks
Secondary	Pyridoxal phosphate (Vitamin B6 marker)	Measured on HPLC	Change over 16 weeks