Increasing Folate Status of a General Population(FOLSUPP STUDY)

This study has been completed.
Sponsor:
Collaborators:
Food Standards Agency, United Kingdom
University of Sheffield
Information provided by (Responsible Party):
Institute of Food Research
ClinicalTrials.gov Identifier:
NCT00372645
First received: September 6, 2006
Last updated: February 15, 2013
Last verified: February 2013
  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
Dietary Supplement: Folic acid (supplement)
Dietary Supplement: Metafolin (supplement)
Drug: Placebo
Other: Folate rich foods

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Institute of Food Research:

Primary Outcome Measures:
  • Folate status [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Homocysteine status [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardio vascular disease markers [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Pulse wave velocity [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 180
Study Start Date: May 2005
Study Completion Date: January 2012
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet
200 µg folate per day from folate-rich foods
Other: Folate rich foods
200 µg folate per day from folate-rich foods
Experimental: Folic acid supplement
200 µg folate per day from supplemental folic acid
Dietary Supplement: Folic acid (supplement)
200 µg folate per day from supplemental folic acid
Experimental: Metfolin supplement
200 µg folate per day from supplemental Metafolin®
Dietary Supplement: Metafolin (supplement)
200 µg folate per day from supplemental Metafolin®
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo

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
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, see Learn About Clinical Studies.

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

Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
University of Sheffield
Sheffield, Yorkshire, United Kingdom, S10 2FN
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

Additional Information:
No publications provided

Responsible Party: Institute of Food Research
ClinicalTrials.gov Identifier: NCT00372645     History of Changes
Other Study ID Numbers: IFR001/2005, NORFOLK LREC 05/Q0101/51, FSA GRANT NUMBER N05057, IFR PROJECT NUMBER 51943F
Study First Received: September 6, 2006
Last Updated: February 15, 2013
Health Authority: United Kingdom: National Health Service

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

ClinicalTrials.gov processed this record on October 22, 2014