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

NCT ID: NCT05488106

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Pressure Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind placebo controlled parallel design
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dose 1

Group Type ACTIVE_COMPARATOR

Riboflavin 1.6mg/d

Intervention Type DIETARY_SUPPLEMENT

Riboflavin 1.6mg/d

Dose 2

Group Type ACTIVE_COMPARATOR

Riboflavin 5mg/d

Intervention Type DIETARY_SUPPLEMENT

Riboflavin 5mg/d

Dose 3

Group Type ACTIVE_COMPARATOR

Riboflavin 20mg/d

Intervention Type DIETARY_SUPPLEMENT

Riboflavin 20mg/d

Interventions

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Placebo

Placebo

Intervention Type DIETARY_SUPPLEMENT

Riboflavin 1.6mg/d

Riboflavin 1.6mg/d

Intervention Type DIETARY_SUPPLEMENT

Riboflavin 5mg/d

Riboflavin 5mg/d

Intervention Type DIETARY_SUPPLEMENT

Riboflavin 20mg/d

Riboflavin 20mg/d

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

University of Ulster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Human Intervention Studies Unit, Ulster University

Coleraine, Co.Londonderry, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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REC/19/0079

Identifier Type: -

Identifier Source: org_study_id

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