Increasing Folate Status of a General Population(FOLSUPP STUDY)
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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 |
- 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 ]
- 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 |
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| United Kingdom | |
| Institute of Food Research | |
| Norwich, Norfolk, United Kingdom, NR4 7UA | |
| University of Sheffield | |
| Sheffield, Yorkshire, United Kingdom, S10 2FN | |
| 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:
|
Cardiovascular Diseases Folic Acid Vitamin B Complex Hematinics Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013