Clinical Trials Logo

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 Not yet recruiting
Phase N/A
Start date April 1, 2024
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Completed NCT03310203 - The Relation Between Adiposity, Inflammation, Glycaemia and Iron Absorption N/A
Completed NCT01493297 - Effects of Vitamin A and Carotenoids on Iron Absorption N/A
Active, not recruiting NCT02979132 - Iron Long-Term Labelling Study Switzerland N/A
Completed NCT03586245 - Iron Absorption From Iron Enriched Aspergillus Oryzae in Females Using Stable Isotope Methodology N/A
Completed NCT04774016 - Iron Absorption From an Iron-fortified Follow-up Formula With Added Synbiotic or Human Milk Oligosaccharides N/A
Active, not recruiting NCT02977806 - Iron Long-Term Labelling Study Malawi
Completed NCT02197624 - Genetic Variants and Iron Absorption N/A
Active, not recruiting NCT02979080 - Iron Long-Term Labelling Study Benin N/A
Recruiting NCT05973552 - Iron Absorption and Requirements in Pregnancy and Lactation
Completed NCT03894358 - Iron Absorption From a Wheat-based Instant Cereal:Gut and Stable Isotope Studies in Kenyan Infants N/A
Completed NCT01489007 - Iron Absorption in Vegetarian Children
Not yet recruiting NCT06236620 - Iron and Zinc Absorption in Flakes Derived From Sprouted or Hydrothermally Processed Wheat N/A
Completed NCT05266703 - Defining the Serum Ferritin Concentration in Kenyan Women at Which the Body Senses Iron Depletion and Begins to Upregulate Iron Absorption N/A
Completed NCT02228902 - Iron Absorption Trial Phase 4
Completed NCT01423162 - Iron Bioavailability of Fortified Oat Drink Phase 4
Completed NCT01483092 - Effect of Inulin on Iron Absorption in Humans N/A
Completed NCT03453918 - Effects of Polyphenols on Iron Absorption in Iron Overload Disorders. N/A