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

• Sponsor: Wageningen Centre for Food Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00130585
• Collaborator: Wageningen University (Other)
• Enrollment: 75
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 73.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Folate Bioavailability; Healthy	Behavioral: Controlled diet; Behavioral: folic acid supplement; Behavioral: 13C11-labelled folic acid supplement	N/A

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 Design

• Study Type: Interventional
• 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
• Study Start Date: May 1, 2005
• Study Completion Date: Jun 1, 2005

Outcome Measures

Primary Outcome Measures

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

2. Bioavailability based on change in folate concentration in plasma []

Secondary Outcome Measures

1. Bioavailability based on change in concentration in plasma homocysteine []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00130585
• Other Study ID Numbers: A-007-RW
• First Posted: Aug 15, 2005
• Last Update Posted: Oct 4, 2005
• Last Verified: Aug 1, 2005

• Keywords provided by , ,: Folate; Bioavailability; Stable isotopes
• Additional relevant MeSH terms: Folic Acid; Vitamin B Complex

Study Results

No Results Posted as of Oct 4, 2005