Effects of Dietary Folate and Phytate Zinc Absorption: Zinc Amino Acid Complexes vs. Zinc-chloride

December 19, 2022 updated by: University of California, Berkeley

Comparison of the Effects of Dietary Folate and Phytate on the Absorption of Zinc From Either Zinc-amino Acids (ZnAA) or Zinc-chloride (ZnCl2)

The purpose of this study is to determine the effects of consuming a small breakfast of juice and toast with added phytate or with taking a folic acid supplement on the absorption of a small amount of zinc that is either bound to amino acids or to chloride or picolinate. The results of this study will provide new information on how components of diet (e.g., phytate, and folic acid) affect the absorption of different forms of dietary zinc (e.g., zinc bound to amino acids, zinc chloride, and zinc picolinate).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94720
        • University of California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Apparently healthy men (i.e., have no current health issues requiring medications or a specific diet), 19 to 50 years of age, with a body mass index between 18 and 30 kg/m2, and willing to eat only the foods provided by the study for 17 days

Exclusion Criteria:

  • Those reporting current chronic or acute diseases or HIV diagnosis, food allergies, smoking tobacco or marijuana, alcohol abuse, any contraindication to venipuncture such as bleeding disorders or use of blood thinners; use of illicit drugs; regular consumption of medications, micronutrient supplements, or both. Vegetarians, or those unable to eat meat, are also excluded since the foods for the study contain meat.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Zinc absorption study
Zinc absorption is determined from each of 3 test meals in all subjects.
Other: Regular toast and juice
Participants consume a single test meal composed of regular whole wheat toast and apple juice, and zinc absorption is measured.
Other: High phytate toast and juice
Participants consume a single test meal composed of high phytate whole wheat toast and apple juice, and zinc absorption is measured.
Other: Regular toast and juice, with folic acid
Participants consume a single test meal composed of regular whole wheat toast and apple juice, with 400 mcg folic acid; and zinc absorption is measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional zinc absorption
Time Frame: 48 hours
Oral zinc tracer to tracee ratio in plasma, as a fraction of intravenous zinc tracer to tracee ratio
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Investigators

  • Principal Investigator: Janet C King, Ph.D., University of California, Berkeley

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Estimate)

December 21, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-01-12879

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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