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

Primary Purpose

Blood Pressure, Hypertension

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Riboflavin 1.6mg/d
Riboflavin 5mg/d
Riboflavin 20mg/d
Sponsored by
University of Ulster
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Pressure focused on measuring Blood Pressure, MTHFR, Methylenetetrahydrofolate Reductase, Riboflavin, Flow-Mediated Dilation, Nitric Oxide

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Human Intervention Studies Unit, Ulster University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Dose 1

Dose 2

Dose 3

Arm Description

Outcomes

Primary Outcome Measures

Systolic blood pressure
Branchial blood pressure
Diastolic blood pressure
Branchial blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
August 2, 2022
Last Updated
August 4, 2022
Sponsor
University of Ulster
Collaborators
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05488106
Brief Title
Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults
Acronym
InteRVENE
Official Title
Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults (InteRVENE Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Ulster
Collaborators
DSM Nutritional Products, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Hypertension
Keywords
Blood Pressure, MTHFR, Methylenetetrahydrofolate Reductase, Riboflavin, Flow-Mediated Dilation, Nitric Oxide

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo controlled parallel design
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Dose 1
Arm Type
Active Comparator
Arm Title
Dose 2
Arm Type
Active Comparator
Arm Title
Dose 3
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Riboflavin 1.6mg/d
Intervention Description
Riboflavin 1.6mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Riboflavin 5mg/d
Intervention Description
Riboflavin 5mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Riboflavin 20mg/d
Intervention Description
Riboflavin 20mg/d
Primary Outcome Measure Information:
Title
Systolic blood pressure
Description
Branchial blood pressure
Time Frame
Change over 16 weeks
Title
Diastolic blood pressure
Description
Branchial blood pressure
Time Frame
Change over 16 weeks
Secondary Outcome Measure Information:
Title
Endothelial function
Description
Measured by Flow Mediated Dilation
Time Frame
Change over 16 weeks
Title
Nitric oxide bioavailability
Description
Plasma nitrite and nitrate oxide analysed by a Sievers gas-phase chemiluminescence nitric oxide analyser
Time Frame
Change over 16 weeks
Title
Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)
Description
Measured on automatic analyser
Time Frame
Change over 16 weeks
Title
Pyridoxal phosphate (Vitamin B6 marker)
Description
Measured on HPLC
Time Frame
Change over 16 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male only
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Human Intervention Studies Unit, Ulster University
City
Coleraine
State/Province
Co.Londonderry
ZIP/Postal Code
BT52 1SA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Company funded work, no plan to share IPD

Learn more about this trial

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

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