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| ID | Type | Description | Link |
|---|---|---|---|
| NORFOLK LREC 05/Q0101/51 | |||
| FSA GRANT NUMBER N05057 | |||
| IFR PROJECT NUMBER 51943F |
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| Name | Class |
|---|---|
| Food Standards Agency, United Kingdom | OTHER_GOV |
| University of Sheffield | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet | Experimental | 200 µg folate per day from folate-rich foods |
|
| Folic acid supplement | Experimental | 200 µg folate per day from supplemental folic acid |
|
| Metfolin supplement | Experimental | 200 µg folate per day from supplemental Metafolin® |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic acid (supplement) | Dietary Supplement | 200 µg folate per day from supplemental folic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Folate status | Baseline and 16 weeks | |
| Homocysteine status | Baseline and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cardio vascular disease markers | Baseline and 16 weeks | |
| Inflammatory markers | Baseline and 16 weeks | |
| Pulse wave velocity |
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Inclusion Criteria:
Exclusion Criteria:
[As the capsules are prepared from gelatin, true vegetarians may not wish to participate]
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| Name | Affiliation | Role |
|---|---|---|
| Paul M Flingas, BSc | Quadram Institute Bioscience | Principal Investigator |
| Hilary Powers, BSc PhD | University of Sheffield | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Food Research | Norwich | Norfolk | NR4 7UA | United Kingdom | ||
| University of Sheffield |
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| Label | URL |
|---|---|
| Institute of Food Research home page | View source |
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| ID | Term |
|---|---|
| D005492 | Folic Acid |
| C569381 | levomefolate calcium |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Metafolin (supplement) | Dietary Supplement | 200 µg folate per day from supplemental Metafolin® |
|
| Placebo | Drug | Placebo |
|
| Folate rich foods | Other | 200 µg folate per day from folate-rich foods |
|
| Baseline and 16 weeks |
| Sheffield |
| Yorkshire |
| S10 2FN |
| United Kingdom |
| D006571 | Heterocyclic Compounds |