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RIBOGENE: Optimisation of Riboflavin Status in Hypertensive Adults With a Genetic Predisposition to Elevated Blood Pressure (RIBOGENE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02463513
Recruitment Status : Unknown
Verified May 2016 by University of Ulster.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2015
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
University of Ulster

Brief Summary:

Approximately 10% of the world's population have a particular genetic makeup (known as the TT genotype) that may increase their risk of having higher blood pressure. Previous work conducted by the investigators research group at the University of Ulster, in collaboration with clinical colleagues from across Northern Ireland, in premature CVD patients and hypertensive adults generally has demonstrated that a dietary level of riboflavin (1.6mg/d) decreases blood pressure, specifically in those with the TT genotype. To date, the blood pressure lowering effects of higher doses of riboflavin in individuals with the TT genotype is not known. The aim of this study is to investigate whether supplementation with riboflavin at a low dose supplemental level (10mg/d) can decrease blood pressure more effectively than the dietary level (1.6mg/d) by optimising riboflavin status and normalising MTHFR activity. This aim will be achieved by conducting a double-blind placebo-controlled intervention study over a 16 week period.

Participants will be recruited from cohorts screened for the methylenetetrahydrofolate reductase (MTHFR) C677T polymorphism. Those identified with the TT genotype (homozygous for the polymorphism) that wish to participate in this research will be asked to attend a baseline and week-16 appointment and will be asked to take a daily riboflavin (1.6 or 10mg/d) or placebo capsule for the duration of the study. At each appointment a blood sample will be taken and blood pressure, height, weight and waist circumference will be measured. If the results of this study show that intervention with a higher dose of riboflavin can lower blood pressure more effectively in individuals with the TT genotype this will have important implications for those responsible for the management of blood pressure. The findings will be of particular relevance in populations with a higher prevalence of the polymorphism.


Condition or disease Intervention/treatment Phase
Participants With the MTHFR 677TT Genotype Dietary Supplement: Placebo comparator Dietary Supplement: 1.6mg riboflavin (Vitamin B2) Dietary Supplement: 10mg riboflavin (Vitamin B2) Not Applicable

Detailed Description:

Recruitment - Potential participants will be identified and recruited via GP practices, hospital outpatient clinics, pharmacies and workplaces throughout Northern Ireland. A letter of invitation and a study package containing a participant information sheet to explain the study, a consent form and a buccal swab DNA collection kit will be included.

Inclusion / Exclusion The main inclusion criteria are that individuals must have the TT genotype. Exclusion criteria includes a history of gastrointestinal, hepatic, renal or haematological disorders, B-vitamin supplements consumer (including multi-vitamins containing B-vitamins), anticonvulsant therapy or any other drugs known to interfere with folate/B-vitamin metabolism. Suitable individuals that participated in the screening process will be contacted and invited to participate in the intervention study. Participants will be given at least forty eight hours to consider the written information and decide if they wish to participate.

Study Design

Participants with the TT genotype who have given informed consent will be stratified by blood pressure and subsequently randomised to receive placebo, low dose (1.6mg/d) or low supplemental dose (10mg/d) riboflavin for the 16 week intervention period. It is important to be aware that no upper limit has been established for this water-soluble B-vitamin and there are no safety concerns regarding these doses of riboflavin or indeed higher doses (including 25mg/d) administered in previous studies (Madigan et al. 1998).

Participants, depending on geographical location, will be asked to attend two appointments (Baseline and week 16) at the participants local GP Practice, The Clinical Translational Research and Innovation Centre (CTRIC) at Altnagelvin Area Hospital, The Welcome Trust-Wolfson Northern Ireland Clinical Research Facility (NICRF) Belfast City Hospital, the Northern Ireland Centre for Food & Health (NICHE) (University of Ulster, Coleraine) or at another convenient location. At both sampling points blood pressure (SBP/DBP mmHg) will be measured, a 30ml blood sample will be taken by a trained phlebotomist and the patient's height (m), weight (kg), waist circumference (cm) and BMI (kg/m2) will be measured. A detailed health and lifestyle questionnaire will collect information on medical and family history, medication and supplement use and dietary intake.

Statistical analysis Statisticalanalysis will be performed using SPSS (Statistical Package for Social Sciences, Version 17.0; SPSS UK Ltd, Chersey, United Kingdom). Data that is not normally distributed will be transformed to obtain normality before statistical analysis is performed. Data will then be analysed to investigate if any differences exist in the BP response between the two riboflavin treatment groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: RIBOGENE: Optimisation of Riboflavin Status in Hypertensive Adults With a Genetic Predisposition to Elevated Blood Pressure
Study Start Date : February 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arm Intervention/treatment
Placebo Comparator: Treatment 1 Dietary Supplement: Placebo comparator
2 week placebo washout + 16 weeks intervention (placebo)

Active Comparator: Treatment 2 Dietary Supplement: 1.6mg riboflavin (Vitamin B2)
2 week placebo washout + 16 weeks intervention (1.6mg riboflavin per day)

Active Comparator: Treatment 3 Dietary Supplement: 10mg riboflavin (Vitamin B2)
2 week placebo washout + 16 weeks intervention (10mg riboflavin per day)




Primary Outcome Measures :
  1. Blood Pressure [ Time Frame: 16 weeks ]
    The aim of this study is to investigate whether a low dose supplemental level (10mg/d) of riboflavin can decrease blood pressure more effectively than the dietary level (1.6mg/d) by optimising riboflavin status and normalising MTHFR activity.


Secondary Outcome Measures :
  1. Erythrocyte Glutathione Reductase Activation Coefficient (EGRAC) [ Time Frame: 16 weeks ]
    Indicator of Vitamin B2 status

  2. Plasma Homocysteine [ Time Frame: 16 weeks ]
  3. Red cell folate [ Time Frame: 16 weeks ]
  4. Vitamin B12 [ Time Frame: 16 weeks ]
  5. Vitamin B6 [ Time Frame: 16 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Over 18 years old

Exclusion Criteria:

  • History of gastrointestinal; Hepatic; Renal or haematological disorders
  • Taking B-vitamin supplements (including multi-vitamins containing B-vitamins), anticonvulsant therapy or any other drugs known to interfere with folate/B-vitamin metabolism.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02463513


Locations
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United Kingdom
Northern Ireland Clinical Research Facility (NICRF)
Belfast, N.Ireland, United Kingdom, BT9 7AB
Human Intervention Studies Unit, University of Ulster
Coleraine, N.Ireland, United Kingdom, BT52 1SA
Clinical Translational Research and Innovation Centre (C-TRIC)
Londonderry, N.Ireland, United Kingdom, BT47 6SB
Sponsors and Collaborators
University of Ulster
DSM Nutritional Products, Inc.

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Responsible Party: University of Ulster
ClinicalTrials.gov Identifier: NCT02463513    
Other Study ID Numbers: OREC 12/NI/0136
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by University of Ulster:
Riboflavin
Blood pressure
MTHFR
Methylenetetrahydrofolate reductase
Additional relevant MeSH terms:
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Hypertension
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Vitamins
Riboflavin
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents