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Increasing Folate Status of a General Population(FOLSUPP STUDY)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372645
First Posted: September 7, 2006
Last Update Posted: March 24, 2015
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.
Collaborators:
Food Standards Agency, United Kingdom
University of Sheffield
Information provided by (Responsible Party):
Quadram Institute
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Quadram Institute:

Primary Outcome Measures:
  • Folate status [ Time Frame: Baseline and 16 weeks ]
  • Homocysteine status [ Time Frame: Baseline and 16 weeks ]

Secondary Outcome Measures:
  • Cardio vascular disease markers [ Time Frame: Baseline and 16 weeks ]
  • Inflammatory markers [ Time Frame: Baseline and 16 weeks ]
  • Pulse wave velocity [ Time Frame: Baseline and 16 weeks ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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
Quadram Institute
Food Standards Agency, United Kingdom
University of Sheffield
Investigators
Principal Investigator: Paul M Flingas, BSc Quadram Institute
Principal Investigator: Hilary Powers, BSc PhD University of Sheffield
  More Information

Additional Information:
Responsible Party: Quadram Institute
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
First Submitted: September 6, 2006
First Posted: September 7, 2006
Last Update Posted: March 24, 2015
Last Verified: February 2013

Keywords provided by Quadram Institute:
Healthy

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs