Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06327529 |
Other study ID # |
2101814 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 1, 2024 |
Est. completion date |
December 31, 2024 |
Study information
Verified date |
March 2024 |
Source |
University of California, Davis |
Contact |
Roberta R Holt, PhD |
Phone |
530-400-5952 |
Email |
rrholt[@]ucdavis.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
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.
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.