|
|
|
|
|
|
Sponsors and Collaborators: |
Institute of Food Research Food Standards Agency, United Kingdom University of Sheffield |
Information provided by: | Institute of Food Research |
ClinicalTrials.gov Identifier: | NCT00372645 |
The aim of this study is to determine the best source of folate to raise the folate status of a general population over a 16 week intervention period.
Condition | Intervention |
Healthy |
Drug: Folic acid (supplement) Drug: Metafolin (supplement) Drug: Placebo Drug: Folate rich foods |
MedlinePlus related topics: | Dietary Supplements |
ChemIDplus related topics: | Folic acid |
Study Type: | Interventional |
Study Design: | Educational/Counseling/Training, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects Of A Mixed Diet Intervention Versus Folic Acid Supplementation And Metafolin® Supplementation On Folate Status And Cardiovascular Disease Risk Factors In Healthy Adults |
Estimated Enrollment: | 180 |
Study Start Date: | May 2005 |
Estimated Study Completion Date: | March 2008 |
This study is designed to assess whether increasing the consumption of natural food folates from a mixed diet is as effective as supplemental folic acid or supplemental natural folate in raising folate status, reducing biomarkers of cardio vascular disease (CVD) risk, and improving vascular function. Randomised placebo-controlled parallel studies will be undertaken in groups of individuals in Norwich and Sheffield. There will be four treatment arms: a) 200 µg folate per day from folate-rich foods, b) 200 µg folate per day from supplemental folic acid, c) 200 µg folate per day from supplemental Metafolin® (6S 5-methyltetrahydrofolic acid) and d) a placebo group. Results from the two centres will be combined, thus ensuring a wide population is covered. Folate status, biomarkers of CVD risk and vascular function (pulse wave velocity) will be measured before and following the intervention period of 16 weeks, together with possible confounders (such as vitamins B2 & B12 status, and MTHFR genotype). 7-Day weighed intakes will be used to measure habitual B-vitamin intake during baseline and intervention, to determine changes in folate intake and assist compliance. Additionally, folate content of selected folate-rich foods will be determined for each volunteer. The results will aid the Food Standards Agency (FSA) in formulating public health policy related to improving folate status and reducing CVD risk.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
[As the capsules are prepared from gelatin, true vegetarians may not wish to participate]
Contact: Paul M Finglas, BSc | +44 1603 255318 | paul.finglas@bbsrc.ac.uk |
Contact: Carline A Wolfe, BSc PhD | +44 1603 255394 | caroline.wolfe@bbsrc.ac.uk |
United Kingdom, Norfolk | |||||
Institute of Food Research | Recruiting | ||||
Norwich, Norfolk, United Kingdom, NR4 7UA | |||||
Contact: Caroline A Wolfe, BSc PhD +44 1603 255394 caroline.wolfe@bbsrc.ac.uk | |||||
Principal Investigator: Paul M Finglas, BSc | |||||
United Kingdom, Yorkshire | |||||
University of Sheffield | Recruiting | ||||
Sheffield, Yorkshire, United Kingdom, S10 2FN | |||||
Contact: Hilary J Powers, BSc Phd +44 114 2715381 h.j.powers@sheffield.ac.uk | |||||
Principal Investigator: Hilary J Powers, BSc PhD |
Institute of Food Research |
Food Standards Agency, United Kingdom |
University of Sheffield |
Principal Investigator: | Paul M Flingas, BSc | Institute of Food Research |
Principal Investigator: | Hilary Powers, BSc PhD | University of Sheffield |
Institute of Food Research home page 
  |
Study ID Numbers: | IFR001/2005, NORFOLK LREC 05/Q0101/51, FSA GRANT NUMBER N05057, IFR PROJECT NUMBER 51943F |
First Received: | September 6, 2006 |
Last Updated: | October 12, 2006 |
ClinicalTrials.gov Identifier: | NCT00372645 |
Health Authority: | United Kingdom: National Health Service |
|
|
|