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NCT Number: NCT06327529

Zinc and Iron Absorption From Common Beans in Young Adult Women

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.

Recruiting

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Key information

Age range

19 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition

Davis, California, 95616, United States

Location status: Recruiting

Location contact

Roberta R Holt, PhD

CONTACT

[email protected]

530-752-4950

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SER 118

Other

Bean High in Phytic Acid and High in Inhibitory Polyphenols

LMP 1001

Other

Bean Low in Phytic Acid and High in Inhibitory Polyphenols

LPA 586

Other

Bean Low in Phytic Acid and Low in Inhibitory Polyphenols

KAT B1

Other

Bean High in Phytic Acid and Low in Inhibitory Polyphenols

Primary outcomes

  1. Fractional Zinc absorption

    Time frame: 24 hours after first intake

    amount of zinc absorbed and circulating in blood

  2. Fractional Iron absorption

    Time frame: 24 hours after first intake

    amount of iron absorbed and circulating in the blood

Secondary outcomes

  1. Total Zinc absorption

    Time frame: 24 hours after first intake

    total amount of zinc absorbed from meals

  2. Total Iron absorption

    Time frame: 24 hours after first intake

    total amount of iron absorbed from meals

Study contacts

Contact information is provided by the study sponsor or research team.

Roberta R Holt, PhD

CONTACT

[email protected]

530-400-5952

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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