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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Other: Folate rich foods; Dietary supplement: Folic acid (supplement); Dietary supplement: Metafolin (supplement)

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UA
      • Institute of Food Research
  • Yorkshire
    • Sheffield, Yorkshire, United Kingdom, S10 2FN
      • University of Sheffield

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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]

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Diet; 200 µg folate per day from folate-rich foods	Other: Folate rich foods; 200 µg folate per day from folate-rich foods
Experimental: Folic acid supplement; 200 µg folate per day from supplemental folic acid	Dietary supplement: Folic acid (supplement); 200 µg folate per day from supplemental folic acid
Experimental: Metfolin supplement; 200 µg folate per day from supplemental Metafolin®	Dietary supplement: Metafolin (supplement); 200 µg folate per day from supplemental Metafolin®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Folate status	Baseline and 16 weeks
Homocysteine status	Baseline and 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Quadram Institute Bioscience
• Collaborators: University of Sheffield; Food Standards Agency, United Kingdom
• Investigators: Principal Investigator: Paul M Flingas, BSc, Quadram Institute Bioscience; Principal Investigator: Hilary Powers, BSc PhD, University of Sheffield

Publications and helpful links

Helpful Links

• Institute of Food Research home page

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 6, 2006
• First Submitted That Met QC Criteria: September 6, 2006
• First Posted (Estimate): September 7, 2006

Study Record Updates

• Last Update Posted (Estimate): March 24, 2015
• Last Update Submitted That Met QC Criteria: March 23, 2015
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Healthy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Hematinics; Folic Acid
• Other Study ID Numbers: IFR001/2005; NORFOLK LREC 05/Q0101/51; FSA GRANT NUMBER N05057; IFR PROJECT NUMBER 51943F