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Clinical Trial Summary

Fifteen female study participants will be enrolled in a randomized crossover study to measure fractional and total zinc and iron absorption from four common bean (Phaseolus vulgaris) varieties with varying phytate and polyphenolic contents. Phytate, the storage form of phosphorus in plants, and polyphenols, which contribute to the varied colors of common beans, are natural components of the beans and can reduce zinc and iron bioavailability from these foods.


Clinical Trial Description

Each participant will attend a total of 10 study visits. The first visit will be a screening visit to determine eligibility, and will include the administration of health history and food frequency questionnaires, and a urine pregnancy test. Participant will also be given a ASA24 24-hour dietary recall at visit 1 to return at visit 2. All subsequent visits (2 through 10) will begin with a blood sample (15 mL, or 1 tablespoon, after a 12 hour overnight fast). Visit 2 will establish the baseline distribution of naturally occurring zinc and iron isotopes in the blood, and will include the administration of water enriched in zinc of a specific naturally-occurring isotopic mass (zinc-68, 4 mg). Visits 2-5 will be on consecutive days, while Visit 6 will be 14 days following Visit 5. Visits 3 and 4 will include breakfast, lunch, and dinner, each containing a small serving of beans that are enriched in specific isotopic masses of iron and zinc (2 mg each of zinc-67 and iron-57, or 1 mg each of zinc-70 and iron-58). Visits 5 and 6 are for blood sampling, to measure the zinc in blood plasma (Visit 5) and the iron that has reached a 14-day equilibrium in red blood cells (Visit 6). Participants will also be given a ASA24 24-hour dietary recall at visit 6 to return at visit 7. Visits 6-9 will be on consecutive days, starting 28 days (the approximate length of one menstrual cycle) after Visit 3, while Visit 10 will be 14 days following Visit 9. The 28-day timing is needed to minimize the potential influence of natural variation in circulating hormones, on zinc metabolism. A second urine pregnancy test will be administered on Visit 10, to detect any pregnancies that would have occurred at the time of the study meals 2 weeks prior or earlier. Participants will also be given a ASA24 dietary recall at visit 9 to return at visit 10. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06327529
Study type Interventional
Source University of California, Davis
Contact Roberta R Holt, PhD
Phone 530-400-5952
Email rrholt@ucdavis.edu
Status Recruiting
Phase N/A
Start date May 1, 2024
Completion date December 31, 2024

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