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

NCT05488106 | Unknown

• 1 other identifier: REC/19/0079
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure; Hypertension

Keywords

Blood Pressure; MTHFR; Methylenetetrahydrofolate Reductase; Riboflavin; Flow-Mediated Dilation; Nitric Oxide

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure

  Branchial blood pressure

  Change over 16 weeks

• Diastolic blood pressure

  Branchial blood pressure

  Change over 16 weeks

Secondary Outcomes (4)

• Endothelial function

  Change over 16 weeks

• Nitric oxide bioavailability

  Change over 16 weeks

• Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)

  Change over 16 weeks

• Pyridoxal phosphate (Vitamin B6 marker)

  Change over 16 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Dose 1

ACTIVE COMPARATOR

Dietary Supplement: Riboflavin 1.6mg/d

Dose 2

ACTIVE COMPARATOR

Dietary Supplement: Riboflavin 5mg/d

Dose 3

ACTIVE COMPARATOR

Dietary Supplement: Riboflavin 20mg/d

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Riboflavin 1.6mg/d DIETARY_SUPPLEMENT

Riboflavin 1.6mg/d

Dose 1

Riboflavin 5mg/d DIETARY_SUPPLEMENT

Riboflavin 5mg/d

Dose 2

Riboflavin 20mg/d DIETARY_SUPPLEMENT

Riboflavin 20mg/d

Dose 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Male only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male
• Aged 60 years and below
• Pre-screened for MTHFR 677TT genotype (TTs and CCs individuals only invited)

You may not qualify if:

• Consumer of B-vitamin supplements
• Consuming medication that interferes with B-vitamin metabolism

Sponsors & Collaborators

• University of Ulster: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Human Intervention Studies Unit, Ulster University

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

Location

MeSH Terms

Conditions

Hypertension

Interventions

Riboflavin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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

Study Design

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

Model Details: Double blind placebo controlled parallel design

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: September 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)