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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130585
• Other study ID #: A-007-RW
• Status: Completed
• Phase: N/A
• First received: August 12, 2005
• Last updated: October 3, 2005
• Start date: May 2005
• Est. completion date: June 2005

Study information

• Verified date: August 2005
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Folate Bioavailability
• Healthy

Intervention

Behavioral:
• Controlled diet

• folic acid supplement

• 13C11-labelled folic acid supplement

Locations

Country	Name	City	State
Netherlands	Wageningen University	Wageningen

Sponsors (2)

Lead Sponsor	Collaborator
Wageningen Centre for Food Sciences	Wageningen University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bioavailability based on change in labelled folate concentration in plasma;
Primary	Bioavailability based on change in folate concentration in plasma
Secondary	Bioavailability based on change in concentration in plasma homocysteine