- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06327529
Zinc and Iron Absorption From Common Beans in Young Adult Women
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Roberta R Holt, PhD
- Phone Number: 530-400-5952
- Email: rrholt@ucdavis.edu
Study Locations
-
-
California
-
Davis, California, United States, 95616
- Department of Nutrition
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bean Variety 1
Enriched with Zinc-67, Iron-57
|
Bean High in Phytic Acid and High in Inhibitory Polyphenols
|
Experimental: Bean Variety 2
Enriched with Zinc-70, Iron-58
|
Bean Low in Phytic Acid and High in Inhibitory Polyphenols
|
Experimental: Bean Variety 3
Enriched with Zinc-67, Iron-57
|
Bean Low in Phytic Acid and Low in Inhibitory Polyphenols
|
Experimental: Bean Variety 4
Enriched with Zinc-70, Iron-58
|
Bean High in Phytic Acid and Low in Inhibitory Polyphenols
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fractional Zinc absorption
Time Frame: 24 hours after first intake
|
amount of zinc absorbed and circulating in blood
|
24 hours after first intake
|
Fractional Iron absorption
Time Frame: 24 hours after first intake
|
amount of iron absorbed and circulating in the blood
|
24 hours after first intake
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Zinc absorption
Time Frame: 24 hours after first intake
|
total amount of zinc absorbed from meals
|
24 hours after first intake
|
Total Iron absorption
Time Frame: 24 hours after first intake
|
total amount of iron absorbed from meals
|
24 hours after first intake
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew G Hall, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2101814
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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