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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 31, 2024
Est. primary completion date August 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years to 24 Years
Eligibility Inclusion Criteria: - Healthy eumenorrheic (regular monthly menstrual cycles of 25-30-days in length) - BMI 18.5 - 30 kg/m2 - Regular consumer of beans, i.e. = 4 servings per month - Usual iron intake estimated by Food Frequency Questionnaire to be less than the Recommended Daily Allowance (RDA) of 18 mg/d (8) - Subject is willing and able to comply with the study protocols. - Subject is willing to participate in all study procedures. Exclusion Criteria: - Dislike or allergy to beans - Self-reported current or recent pregnancy (within the past 12 months) - Self-reported recent termination of pregnancy (3 months if abortion in 1st or 2nd trimester, or 12 months if in 3rd trimester) - Self-reported plans to become pregnant during the study period - Self-reported cancer - Self-reported surgery without the past 12 months - Currently taking prescription drugs, other than for contraception, or any nutritional supplements - Any daily iron supplementation within the past 12 months. - Currently breastfeeding - Any medical conditions affecting iron or zinc metabolism (such as hemochromatosis or sickle cell disease)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SER 118
Bean High in Phytic Acid and High in Inhibitory Polyphenols
LMP 1001
Bean Low in Phytic Acid and High in Inhibitory Polyphenols
LPA 586
Bean Low in Phytic Acid and Low in Inhibitory Polyphenols
KAT B1
Bean High in Phytic Acid and Low in Inhibitory Polyphenols

Locations

Country Name City State
United States Department of Nutrition Davis California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fractional Zinc absorption amount of zinc absorbed and circulating in blood 24 hours after first intake
Primary Fractional Iron absorption amount of iron absorbed and circulating in the blood 24 hours after first intake
Secondary Total Zinc absorption total amount of zinc absorbed from meals 24 hours after first intake
Secondary Total Iron absorption total amount of iron absorbed from meals 24 hours after first intake
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