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

NCT ID: NCT00130585

Last Updated: 2005-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2005-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Folate Bioavailability Healthy

Keywords

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Folate Bioavailability Stable isotopes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Controlled diet

Intervention Type BEHAVIORAL

folic acid supplement

Intervention Type BEHAVIORAL

13C11-labelled folic acid supplement

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen University

OTHER

Sponsor Role collaborator

Wageningen Centre for Food Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Petra Verhoef, Dr.

Role: PRINCIPAL_INVESTIGATOR

Wageningen Centre for Food Sciences

Martijn Katan, Professor

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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A-007-RW

Identifier Type: -

Identifier Source: org_study_id