Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372645
Status:
COMPLETED
Last Update Posted:
2015-03-24
First Post:
2006-09-06
Brief Title:
Increasing Folate Status of a General PopulationFOLSUPP STUDY
Sponsor:
Quadram Institute Bioscience
Organization:
Quadram Institute Bioscience
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IFR PROJECT NUMBER 51943F | None | None | None |
| NORFOLK LREC 05Q010151 | None | None | None |
| FSA GRANT NUMBER N05057 | None | None | None |