HealthyNCT00372645
Increasing Folate Status of a General Population(FOLSUPP STUDY)
A study testing Folic acid (supplement), Metafolin (supplement) and Folate rich foods in people with Healthy, run by Quadram Institute Bioscience at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Folic acid (supplement), Metafolin (supplement) and Folate rich foods
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- May 2005to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18-65 years
- Smokers and non-smokers
Who cannot join
- 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
Show all 9Show fewer
- 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]
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Institute of Food Research
Norwich, Norfolk, NR4 7UA
University of Sheffield
Sheffield, Yorkshire, S10 2FN
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Folic acid (supplement), Metafolin (supplement), Placebo, Folate rich foods
- Keywords
- Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic acid (supplement)Dietary supplement
200 µg folate per day from supplemental folic acid
Metafolin (supplement)Dietary supplement
200 µg folate per day from supplemental Metafolin®
PlaceboDrug
Placebo
Folate rich foodsOther
200 µg folate per day from folate-rich foods
| Study group | Role | What they receive |
|---|---|---|
| Diet | Experimental | 200 µg folate per day from folate-rich foods Receives: Other: Folate rich foods |
| Folic acid supplement | Experimental | 200 µg folate per day from supplemental folic acid Receives: Dietary Supplement: Folic acid (supplement) |
| Metfolin supplement | Experimental | 200 µg folate per day from supplemental Metafolin® Receives: Dietary Supplement: Metafolin (supplement) |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Folate status
Measured: Baseline and 16 weeks
Homocysteine status
Measured: Baseline and 16 weeks
Secondary outcomes (3)
Cardio vascular disease markers
Measured: Baseline and 16 weeks
Inflammatory markers
Measured: Baseline and 16 weeks
Pulse wave velocity
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startMay 2005
- Primary completionJan 2008
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quadram Institute Bioscience
- Sponsor type
- University, hospital or other
- Collaborators
- Food Standards Agency, United Kingdom, University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Paul M Flingas, BSc, Principal investigator, Quadram Institute BioscienceHilary Powers, BSc PhD, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00372645
- Sponsor's protocol ID
- IFR001/2005
- Other IDs
- NORFOLK LREC 05/Q0101/51, FSA GRANT NUMBER N05057, IFR PROJECT NUMBER 51943F
- Status last verified
- Feb 2013
- First submitted
- 6 Sep 2006
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00372645
- Acronym / sponsor ID
- IFR001/2005
- Conditions
- Healthy
- Keywords
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Quadram Institute BioscienceUniversity, hospital or other
- Collaborators
- Food Standards Agency, United Kingdom, University of Sheffield
- Study start
- May 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet | Experimental | Other: Folate rich foods200 µg folate per day from folate-rich foods |
| Folic acid supplement | Experimental | Dietary Supplement: Folic acid (supplement)200 µg folate per day from supplemental folic acid |
| Metfolin supplement | Experimental | Dietary Supplement: Metafolin (supplement)200 µg folate per day from supplemental Metafolin® |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18-65 years
- Smokers and non-smokers
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic acid (supplement)200 µg folate per day from supplemental folic acid | Dietary supplement | Folic acid supplement |
| Metafolin (supplement)200 µg folate per day from supplemental Metafolin® | Dietary supplement | Metfolin supplement |
| PlaceboPlacebo | Drug | Placebo |
| Folate rich foods200 µg folate per day from folate-rich foods | Other | Diet |
Primary outcome
Folate status
Time frame: Baseline and 16 weeks
Homocysteine status
Time frame: Baseline and 16 weeks
3 secondary outcomes
Cardio vascular disease markers
Time frame: Baseline and 16 weeks
Inflammatory markers
Time frame: Baseline and 16 weeks
Pulse wave velocity
Time frame: Baseline and 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Institute of Food Research home pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul M Flingas, BSc principal investigator
Quadram Institute Bioscience
Hilary Powers, BSc PhD principal investigator
University of Sheffield
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic acid (supplement), Metafolin (supplement) and Folate rich foods in people with Healthy, run by Quadram Institute Bioscience at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Folate status (time frame: Baseline and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.