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

• Sponsor: University of Ulster (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05488106
• Collaborator: DSM Nutritional Products, Inc. (Industry)
• Enrollment: 120
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 9.9
• Patients Per Site Per Month: 12.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Blood Pressure; Hypertension	Dietary Supplement: Placebo; Dietary Supplement: Riboflavin 1.6mg/d; Dietary Supplement: Riboflavin 5mg/d; Dietary Supplement: Riboflavin 20mg/d	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind placebo controlled parallel designDouble blind placebo controlled parallel design
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults (InteRVENE Study)
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Systolic blood pressure [Change over 16 weeks]

   Branchial blood pressure

2. Diastolic blood pressure [Change over 16 weeks]

   Branchial blood pressure

Secondary Outcome Measures

1. Endothelial function [Change over 16 weeks]

   Measured by Flow Mediated Dilation

2. Nitric oxide bioavailability [Change over 16 weeks]

   Plasma nitrite and nitrate oxide analysed by a Sievers gas-phase chemiluminescence nitric oxide analyser

3. Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker) [Change over 16 weeks]

   Measured on automatic analyser

4. Pyridoxal phosphate (Vitamin B6 marker) [Change over 16 weeks]

   Measured on HPLC

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Human Intervention Studies Unit, Ulster University	Coleraine	Co.Londonderry	United Kingdom	BT52 1SA

Sponsors and Collaborators

• University of Ulster
• DSM Nutritional Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Ulster
• ClinicalTrials.gov Identifier: NCT05488106
• Other Study ID Numbers: REC/19/0079
• First Posted: Aug 4, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Ulster: Blood Pressure; MTHFR; Methylenetetrahydrofolate Reductase; Riboflavin; Flow-Mediated Dilation; Nitric Oxide
• Additional relevant MeSH terms: Hypertension; Riboflavin

Study Results

No Results Posted as of Aug 9, 2022