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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00130585
Enrollment
75
Registered
2005-08-15
Start date
2005-05-31
Completion date
2005-06-30
Last updated
2005-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Folate Bioavailability, Healthy

Keywords

Folate, Bioavailability, Stable isotopes

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.

Interventions

BEHAVIORALControlled diet
BEHAVIORAL13C11-labelled folic acid supplement

Sponsors

Wageningen University
CollaboratorOTHER
Wageningen Centre for Food Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Bioavailability based on change in labelled folate concentration in plasma;
Bioavailability based on change in folate concentration in plasma

Secondary

MeasureTime frame
Bioavailability based on change in concentration in plasma homocysteine

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026