Ignite Creation Date:
2024-05-06 @ 7:05 AM
Last Modification Date:
2024-10-26 @ 11:44 AM
Study NCT ID:
NCT02463513
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2015-06-02
Brief Title:
RIBOGENE Optimisation of Riboflavin Status in Hypertensive Adults With a Genetic Predisposition to Elevated Blood Pressure
Sponsor:
University of Ulster
Organization:
University of Ulster
Study Overview
Official Title:
RIBOGENE Optimisation of Riboflavin Status in Hypertensive Adults With a Genetic Predisposition to Elevated Blood Pressure
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RIBOGENE
Brief Summary:
Approximately 10 of the worlds 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 16mgd 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 10mgd can decrease blood pressure more effectively than the dietary level 16mgd 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 16 or 10mgd 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
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 16 or 10mgd 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
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 folateB-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 16mgd or low supplemental dose 10mgd 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 25mgd 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 SBPDBP mmHg will be measured a 30ml blood sample will be taken by a trained phlebotomist and the patients height m weight kg waist circumference cm and BMI kgm2 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 170 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
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 folateB-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 16mgd or low supplemental dose 10mgd 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 25mgd 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 SBPDBP mmHg will be measured a 30ml blood sample will be taken by a trained phlebotomist and the patients height m weight kg waist circumference cm and BMI kgm2 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 170 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None