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
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
-
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California
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Berkeley, California, United States, 94720
- University of California
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-
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 |
|---|---|
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Other: Zinc absorption study
Zinc absorption is determined from each of 3 test meals in all subjects.
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Participants consume a single test meal composed of regular whole wheat toast and apple juice, and zinc absorption is measured.
Participants consume a single test meal composed of high phytate whole wheat toast and apple juice, and zinc absorption is measured.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fractional zinc absorption
Time Frame: 48 hours
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Oral zinc tracer to tracee ratio in plasma, as a fraction of intravenous zinc tracer to tracee ratio
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48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.