Zinc AbsorptionNCT06327529
Zinc and Iron Absorption From Common Beans in Young Adult Women
A study testing SER 118, LMP 1001 and LPA 586 in people with Zinc Absorption and Iron Absorption, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Zinc Absorption, Iron Absorption
- What is being tested?
- SER 118, LMP 1001 and LPA 586
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Nutrition
Davis, California, 95616
Roberta R Holt, PhD, 530-752-4950, rrholt@ucdavis.edu
About this study
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.
Read the 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.
- Conditions
- Zinc Absorption, Iron Absorption
- Being tested
- SER 118, LMP 1001, LPA 586, KAT B1
- Keywords
- zinc, iron, absorption, phytate, polyphenols, beans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SER 118Other
Bean High in Phytic Acid and High in Inhibitory Polyphenols
LMP 1001Other
Bean Low in Phytic Acid and High in Inhibitory Polyphenols
LPA 586Other
Bean Low in Phytic Acid and Low in Inhibitory Polyphenols
KAT B1Other
Bean High in Phytic Acid and Low in Inhibitory Polyphenols
| Study group | Role | What they receive |
|---|---|---|
| Bean Variety 1 | Experimental | Enriched with Zinc-67, Iron-57 Receives: Other: SER 118 |
| Bean Variety 2 | Experimental | Enriched with Zinc-70, Iron-58 Receives: Other: LMP 1001 |
| Bean Variety 3 | Experimental | Enriched with Zinc-67, Iron-57 Receives: Other: LPA 586 |
| Bean Variety 4 | Experimental | Enriched with Zinc-70, Iron-58 Receives: Other: KAT B1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Zinc absorption
amount of zinc absorbed and circulating in blood
Measured: 24 hours after first intake
Fractional Iron absorption
amount of iron absorbed and circulating in the blood
Measured: 24 hours after first intake
Secondary outcomes (2)
Total Zinc absorption
total amount of zinc absorbed from meals
Measured: 24 hours after first intake
Total Iron absorption
total amount of iron absorbed from meals
Measured: 24 hours after first intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zinc AbsorptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A four arm multi-tracer non-randomized crossover design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew G Hall, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327529
- Sponsor's protocol ID
- 2101814
- Status last verified
- Feb 2026
- First submitted
- 18 Mar 2024
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No