Clinical Trials Directory

Trials / Completed

CompletedNCT00130585

Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method

The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
75 (planned)
Sponsor
Wageningen Centre for Food Sciences · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

The main objectives of this project are: 1. to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and 2. to determine the bioavailability with a higher precision than previous methods. The hypothesis is that the bioavailability of dietary folate within a confidence interval of +/-20% can be estimated.

Detailed description

Folate plays a role in the prevention of certain birth defects and possibly also in prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of dietary folate that is absorbed and becomes available for metabolic processes in the body has been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects generally differ a lot in their folate or homocysteine response upon a change in dietary folate intake, the between-person variability in these responses is high. Therefore, bioavailability estimates derived from these responses have large confidence intervals. With this trial the researchers want to determine folate bioavailability with a higher precision than previous trials. A good estimate of folate bioavailability from the general diet is necessary to construct reliable dietary reference intakes for folate.

Conditions

Interventions

TypeNameDescription
BEHAVIORALControlled diet
BEHAVIORALfolic acid supplement
BEHAVIORAL13C11-labelled folic acid supplement

Timeline

Start date
2005-05-01
Completion
2005-06-01
First posted
2005-08-15
Last updated
2005-10-04

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT00130585. Inclusion in this directory is not an endorsement.