Blood PressureInteRVENENCT05488106
Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults
A study testing Riboflavin 1.6mg/d, Riboflavin 5mg/d and Riboflavin 20mg/d in people with Blood Pressure and Hypertension, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- What is being tested?
- Riboflavin 1.6mg/d, Riboflavin 5mg/d and Riboflavin 20mg/d
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 60 years and below
- Pre-screened for MTHFR 677TT genotype (TTs and CCs individuals only invited)
Who cannot join
- Consumer of B-vitamin supplements
- Consuming medication that interferes with B-vitamin metabolism
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Intervention Studies Unit, Ulster University
Coleraine, Co.Londonderry, BT52 1SA
About this study
Official title: 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.
- Conditions
- Blood Pressure, Hypertension
- Being tested
- Placebo, Riboflavin 1.6mg/d, Riboflavin 5mg/d, Riboflavin 20mg/d
- Keywords
- Blood Pressure, MTHFR, Methylenetetrahydrofolate Reductase, Riboflavin, Flow-Mediated Dilation, Nitric Oxide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
Riboflavin 1.6mg/dDietary supplement
Riboflavin 1.6mg/d
Riboflavin 5mg/dDietary supplement
Riboflavin 5mg/d
Riboflavin 20mg/dDietary supplement
Riboflavin 20mg/d
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Dose 1 | Active comparator | Not described Receives: Dietary Supplement: Riboflavin 1.6mg/d |
| Dose 2 | Active comparator | Not described Receives: Dietary Supplement: Riboflavin 5mg/d |
| Dose 3 | Active comparator | Not described Receives: Dietary Supplement: Riboflavin 20mg/d |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Branchial blood pressure
Measured: Change over 16 weeks
Diastolic blood pressure
Branchial blood pressure
Measured: Change over 16 weeks
Secondary outcomes (4)
Endothelial function
Measured by Flow Mediated Dilation
Measured: Change over 16 weeks
Nitric oxide bioavailability
Plasma nitrite and nitrate oxide analysed by a Sievers gas-phase chemiluminescence nitric oxide analyser
Measured: Change over 16 weeks
Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)
Measured on automatic analyser
Measured: Change over 16 weeks
Pyridoxal phosphate (Vitamin B6 marker)
Measured on HPLC
Measured: Change over 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled parallel design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488106
- Sponsor's protocol ID
- REC/19/0079
- Acronym
- InteRVENE
- Status last verified
- Aug 2022
- First submitted
- 2 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Company funded work, no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Riboflavin to Improve Vascular Health and ENdothelial Functioning in Genetically at- Risk Adults (InteRVENE Study)
- ClinicalTrials.gov ID
- NCT05488106
- Acronym / sponsor ID
- InteRVENE / REC/19/0079
- Conditions
- Blood Pressure, Hypertension
- Keywords
- Blood Pressure, MTHFR, Methylenetetrahydrofolate Reductase, Riboflavin, Flow-Mediated Dilation, Nitric Oxide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- dsm-firmenich Switzerland AG
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double blind placebo controlled parallel design
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- Aged 60 years and below
- Pre-screened for MTHFR 677TT genotype (TTs and CCs individuals only invited)
Key exclusion criteria (2 listed)
- Consumer of B-vitamin supplements
- Consuming medication that interferes with B-vitamin metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | Placebo |
| Riboflavin 1.6mg/dRiboflavin 1.6mg/d | Dietary supplement | Dose 1 |
| Riboflavin 5mg/dRiboflavin 5mg/d | Dietary supplement | Dose 2 |
| Riboflavin 20mg/dRiboflavin 20mg/d | Dietary supplement | Dose 3 |
Primary outcome
Systolic blood pressure
Time frame: Change over 16 weeks
Branchial blood pressure
Diastolic blood pressure
Time frame: Change over 16 weeks
Branchial blood pressure
4 secondary outcomes
Endothelial function
Time frame: Change over 16 weeks
Nitric oxide bioavailability
Time frame: Change over 16 weeks
Erythrocyte glutathione reductase activation coefficient (EGRac)(Vitamin B2 marker)
Time frame: Change over 16 weeks
Pyridoxal phosphate (Vitamin B6 marker)
Time frame: Change over 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No. Company funded work, no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Riboflavin 1.6mg/d, Riboflavin 5mg/d and Riboflavin 20mg/d in people with Blood Pressure and Hypertension, run by University of Ulster at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: Change over 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.