Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327529
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-03-18
Brief Title:
Zinc and Iron Absorption From Common Beans in Young Adult Women
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Zinc and Iron Absorption From Common Beans in Young Adult Women
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None