Effects of Dietary Folate and Phytate Zinc Absorption: Zinc Amino Acid Complexes vs. Zinc-chloride
Sponsor
University of California, Berkeley (Other)
Overall Status
Recruiting
CT.gov ID
NCT05273710
Collaborator
(none)
10
1
1
10.2
1
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Comparison of the Effects of Dietary Folate and Phytate on the Absorption of Zinc From Either Zinc-amino Acids (ZnAA) or Zinc-chloride (ZnCl2)
Actual Study Start Date
:
Mar 28, 2022
Anticipated Primary Completion Date
:
Nov 2, 2022
Anticipated Study Completion Date
:
Jan 31, 2023
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Fractional zinc absorption [48 hours]
Oral zinc tracer to tracee ratio in plasma, as a fraction of intravenous zinc tracer to tracee ratio
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California | Berkeley | California | United States | 94720 |
Sponsors and Collaborators
- University of California, Berkeley
Investigators
- Principal Investigator: Janet C King, Ph.D., University of California, Berkeley
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT05273710
Other Study ID Numbers:
- 2020-01-12879
First Posted:
Mar 10, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: