NCT05488106

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Ulster · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Blood Pressure
• Hypertension

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	Placebo
DIETARY_SUPPLEMENT	Riboflavin 1.6mg/d	Riboflavin 1.6mg/d
DIETARY_SUPPLEMENT	Riboflavin 5mg/d	Riboflavin 5mg/d
DIETARY_SUPPLEMENT	Riboflavin 20mg/d	Riboflavin 20mg/d

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-08-04
• Last updated: 2022-08-09

Locations

1 site across 1 country: United Kingdom