Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | The Relative Bioavailability of Folate From a Mixed Diet Compared to Synthetic Folic Acid Using a Stable Isotope Method |
- Bioavailability based on change in labelled folate concentration in plasma;
- Bioavailability based on change in folate concentration in plasma
- Bioavailability based on change in concentration in plasma homocysteine
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2005 |
| Estimated Study Completion Date: | June 2005 |
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 |
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| Netherlands | |
| Wageningen University | |
| Wageningen, Netherlands, 6700EV | |
| Principal Investigator: | Petra Verhoef, Dr. | Wageningen Centre for Food Sciences |
| Principal Investigator: | Martijn Katan, Professor | Wageningen University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00130585 History of Changes |
| Other Study ID Numbers: | A-007-RW |
| Study First Received: | August 12, 2005 |
| Last Updated: | October 3, 2005 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
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 Pharmacologic Actions Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013