Increasing Folate Status of a General Population(FOLSUPP STUDY)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Diet

200 µg folate per day from folate-rich foods

Group Type EXPERIMENTAL

Folate rich foods

Intervention Type OTHER

200 µg folate per day from folate-rich foods

Folic acid supplement

200 µg folate per day from supplemental folic acid

Group Type EXPERIMENTAL

Folic acid (supplement)

Intervention Type DIETARY_SUPPLEMENT

200 µg folate per day from supplemental folic acid

Metfolin supplement

200 µg folate per day from supplemental Metafolin®

Group Type EXPERIMENTAL

Metafolin (supplement)

Intervention Type DIETARY_SUPPLEMENT

200 µg folate per day from supplemental Metafolin®

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Folic acid (supplement)

200 µg folate per day from supplemental folic acid

Intervention Type DIETARY_SUPPLEMENT

Metafolin (supplement)

200 µg folate per day from supplemental Metafolin®

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DRUG

Folate rich foods

200 µg folate per day from folate-rich foods

Intervention Type OTHER

Eligibility Criteria

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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.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes