Increasing Folate Status of a General Population(FOLSUPP STUDY)

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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00372645

Enrollment

180

Registered

2006-09-07

Start date

2005-05-31

Completion date

2012-01-31

Last updated

2015-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy

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.

Interventions

DIETARY_SUPPLEMENTFolic acid (supplement)

200 µg folate per day from supplemental folic acid

DIETARY_SUPPLEMENTMetafolin (supplement)

200 µg folate per day from supplemental Metafolin®

DRUGPlacebo

Placebo

OTHERFolate rich foods

200 µg folate per day from folate-rich foods

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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. \[As the capsules are prepared from gelatin, true vegetarians may not wish to participate\]

Design outcomes

Primary

Measure	Time frame
Folate status	Baseline and 16 weeks
Homocysteine status	Baseline and 16 weeks

Secondary

Measure	Time frame
Cardio vascular disease markers	Baseline and 16 weeks
Inflammatory markers	Baseline and 16 weeks
Pulse wave velocity	Baseline and 16 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026