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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130585
First Posted: August 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wageningen University
Information provided by:
Wageningen University
  Purpose

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.


Condition Intervention
Folate Bioavailability Healthy Behavioral: Controlled diet Behavioral: folic acid supplement Behavioral: 13C11-labelled folic acid supplement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Bioavailability based on change in labelled folate concentration in plasma;
  • Bioavailability based on change in folate concentration in plasma

Secondary Outcome Measures:
  • Bioavailability based on change in concentration in plasma homocysteine

Estimated Enrollment: 75
Study Start Date: May 2005
Estimated Study Completion Date: June 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130585


Locations
Netherlands
Wageningen University
Wageningen, Netherlands, 6700EV
Sponsors and Collaborators
Wageningen Centre for Food Sciences
Wageningen University
Investigators
Principal Investigator: Petra Verhoef, Dr. Wageningen Centre for Food Sciences
Principal Investigator: Martijn Katan, Professor Wageningen University
  More Information

ClinicalTrials.gov Identifier: NCT00130585     History of Changes
Other Study ID Numbers: A-007-RW
First Submitted: August 12, 2005
First Posted: August 15, 2005
Last Update Posted: December 9, 2005
Last Verified: August 2005

Keywords provided by Wageningen University:
Folate
Bioavailability
Stable isotopes

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs