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Completed

NCT Number: NCT00130585

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

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.

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Key information

Conditions

Folate Bioavailability Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wageningen University

Wageningen, 6700EV, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Controlled Diet

Behavioral

folic acid supplement

Behavioral

13C11-labelled folic acid supplement

Behavioral

Primary outcomes

  1. Bioavailability based on change in labelled folate concentration in plasma;

  2. Bioavailability based on change in folate concentration in plasma

Secondary outcomes

  1. Bioavailability based on change in concentration in plasma homocysteine

Sponsors and collaborators

Lead sponsor

Wageningen Centre for Food Sciences

Other

Collaborators

  • Wageningen University

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Aug 15, 2005
Registry last updated
Oct 4, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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