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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Hypertension; Blood Pressure
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Riboflavin 1.6mg/d; Dietary supplement: Riboflavin 5mg/d; Dietary supplement: Riboflavin 20mg/d

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Co.Londonderry
    • Coleraine, Co.Londonderry, United Kingdom, BT52 1SA
      • Human Intervention Studies Unit, Ulster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Active Comparator: Dose 1	Dietary supplement: Riboflavin 1.6mg/d; Riboflavin 1.6mg/d
Active Comparator: Dose 2	Dietary supplement: Riboflavin 5mg/d; Riboflavin 5mg/d
Active Comparator: Dose 3	Dietary supplement: Riboflavin 20mg/d; Riboflavin 20mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Branchial blood pressure	Change over 16 weeks
Diastolic blood pressure	Branchial blood pressure	Change over 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial function	Measured by Flow Mediated Dilation	Change over 16 weeks
Nitric oxide bioavailability	Plasma nitrite and nitrate oxide analysed by a Sievers gas-phase chemiluminescence nitric oxide analyser	Change over 16 weeks
Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)	Measured on automatic analyser	Change over 16 weeks
Pyridoxal phosphate (Vitamin B6 marker)	Measured on HPLC	Change over 16 weeks

Collaborators and Investigators

• Sponsor: University of Ulster
• Collaborators: DSM Nutritional Products, Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 9, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Blood Pressure; Nitric Oxide; MTHFR; Methylenetetrahydrofolate Reductase; Riboflavin; Flow-Mediated Dilation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: REC/19/0079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Company funded work, no plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No