ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Increasing Folate Status of a General Population(FOLSUPP STUDY)

This study is currently recruiting participants.
Verified by Institute of Food Research, September 2006

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
  Purpose

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   

U.S. FDA Resources

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

Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Folate status
  • Homocysteine status

Secondary Outcome Measures:
  • Cardio vascular disease markers
  • Inflammatory markers
  • Pulse wave velocity

Estimated Enrollment:   180
Study Start Date:   May 2005
Estimated Study Completion Date:   March 2008

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Men and women aged 18-65 years
  • Smokers and non-smokers

Exclusion Criteria:

  • Pregnant or has been pregnant within the last 12 months
  • Breastfeeding
  • Has donated or intends to donate blood within 16 weeks of the first or last study samples
  • Fails standard clinical screening of blood and urine for human studies at the Institute of Food Reseach
  • BMI above 18 or below 40
  • Receiving vascular disease or anti-hypertensive drugs
  • Those with diabetes
  • Regularly consuming dietary supplements containing B-vitamins and/or folic acid.

[As the capsules are prepared from gelatin, true vegetarians may not wish to participate]

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372645

Contacts
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    

Locations
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            

Sponsors and Collaborators
Institute of Food Research
Food Standards Agency, United Kingdom
University of Sheffield

Investigators
Principal Investigator:     Paul M Flingas, BSc     Institute of Food Research    
Principal Investigator:     Hilary Powers, BSc PhD     University of Sheffield    
  More Information


Institute of Food Research home page  This link exits the ClinicalTrials.gov site
 

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

Study placed in the following topic categories:
Folic Acid
Healthy

Additional relevant MeSH terms:
Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins
Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2008




Links to all studies - primarily for crawlers