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

Not Applicable

Completed

• Conditions: Folate Bioavailability; Healthy

• Registration Number: NCT00130585
• Lead Sponsor: Wageningen Centre for Food Sciences

Brief 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.

Study Timeline

• Study Start: 2005-05
• Study Completion: 2005-06
• Status Verified: 2005-08
• Study First Submitted: 2005-08-12
• Study First Submitted QC: 2005-08-12
• Study First Posted: 2005-08-15
• Last Update Submitted: 2005-10-03
• Last Update Posted: 2005-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Serum B12 >118pmol/L;
• Serum creatinine <125micromol/L;
• Plasma total homocysteine <26micromol/L.

Exclusion Criteria

• Cardiovascular disease, cancer, rheumatoid arthritis, epilepsy, gastro-intestinal disorders;
• Use of drugs interfering with folate metabolism;
• Use of B vitamins within the period three months prior to the study.
• Body Mass Index (BMI) > 30

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bioavailability based on change in labelled folate concentration in plasma;
Bioavailability based on change in folate concentration in plasma

Secondary Outcome Measures

Name	Time	Method
Bioavailability based on change in concentration in plasma homocysteine

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Netherlands