Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method - Full Text View

Sponsors and Collaborators:	Wageningen Centre for Food Sciences Wageningen University
Information provided by:	Wageningen University
ClinicalTrials.gov Identifier:	NCT00130585

Purpose

The main objectives of this project are:

to determine the relative bioavailability of dietary folate from a total diet, compared with synthetic folic acid and
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

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Folic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Bio-availability Study
Official Title:	The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Study ID Numbers:	A-007-RW
Study First Received:	August 12, 2005
Last Updated:	October 3, 2005
ClinicalTrials.gov Identifier:	NCT00130585
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Wageningen University:

Folate
Bioavailability
Stable isotopes

Study placed in the following topic categories:

Folic Acid
Healthy

Additional relevant MeSH terms:

Vitamin B Complex
Hematinics
Therapeutic Uses
Growth Substances
Vitamins

Hematologic Agents
Physiological Effects of Drugs
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009