NCT06327529

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
May 2024Dec 2026

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

2.7 years

First QC Date

March 18, 2024

Last Update Submit

February 18, 2026

Conditions

Keywords

zincironabsorptionphytatepolyphenolsbeans

Outcome Measures

Primary Outcomes (2)

  • Fractional Zinc absorption

    amount of zinc absorbed and circulating in blood

    24 hours after first intake

  • Fractional Iron absorption

    amount of iron absorbed and circulating in the blood

    24 hours after first intake

Secondary Outcomes (2)

  • Total Zinc absorption

    24 hours after first intake

  • Total Iron absorption

    24 hours after first intake

Study Arms (4)

Bean Variety 1

EXPERIMENTAL

Enriched with Zinc-67, Iron-57

Other: SER 118

Bean Variety 2

EXPERIMENTAL

Enriched with Zinc-70, Iron-58

Other: LMP 1001

Bean Variety 3

EXPERIMENTAL

Enriched with Zinc-67, Iron-57

Other: LPA 586

Bean Variety 4

EXPERIMENTAL

Enriched with Zinc-70, Iron-58

Other: KAT B1

Interventions

SER 118OTHER

Bean High in Phytic Acid and High in Inhibitory Polyphenols

Bean Variety 1

Bean Low in Phytic Acid and High in Inhibitory Polyphenols

Bean Variety 2
LPA 586OTHER

Bean Low in Phytic Acid and Low in Inhibitory Polyphenols

Bean Variety 3
KAT B1OTHER

Bean High in Phytic Acid and Low in Inhibitory Polyphenols

Bean Variety 4

Eligibility Criteria

Age19 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition

Davis, California, 95616, United States

RECRUITING

MeSH Terms

Interventions

atrial natriuretic factor (4-23)NH2, de-Gln(18)-de-Ser(19)-de-Gly(20,22)-de-Leu(21)-

Study Officials

  • Andrew G Hall, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberta R Holt, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study participants will be masked to the type of bean that they will be receiving.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: A four arm multi-tracer non-randomized crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations