Determination of Pre-Absorptive Dissociation of Zinc From a Zinc Amino Acid Complex in Healthy Men

NCT03934346 | Completed DMC

• 1 other identifier: 2019-001
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Zinc may be absorbed from diet via zinc transporter mediated pathways, or, when coupled with amino acids, via amino acid transporter pathways. When zinc is coupled with amino acids in diet, it may dissociate from those amino acids in the acidic environment of the stomach prior to entering the small intestine. An experimentally-determined value for any pre-absorptive dissociation of zinc from a zinc amino acid complex (ZnAA) is necessary for the accurate compartmental modeling of zinc metabolism when provided as ZnAA compared with ionic zinc, which the investigators will perform in a future study. The current study will allow us to determine the dissociation of zinc from ZnAA, while serving as a pilot test of a novel technique to determine for the first time an individual's zinc transport kinetics.

Conditions

Fractional Zinc Absorption

Keywords

zinc; absorption; kinetics; amino acid chelate

Outcome Measures

Primary Outcomes (2)

• Zinc Transport Curve

  The saturable zinc transport curve determined by fitting the zinc absorption data to the Hill transport equation

  2 weeks

• Dissociated Amino Acid Zinc

  Amount of zinc dissociated from the ZnAA prior to absorption

  2 weeks

Study Arms (1)

Zinc transport kinetics

OTHER

Three different amounts of dietary zinc are used in the creation of a standard curve for determining zinc absorption kinetics: 4 mg, 7 mg, and 15 mg of zinc.

Other: Zinc amino acid complex

Interventions

Zinc amino acid complex OTHER

Zinc in the form of a Zinc Amino Acid Complex (ZnAA) is provided with a test diet, and the amount of zinc that dissociates from the ZnAA and is thus absorbed via an ionic zinc transport pathway is determined based on the Hill transport kinetics for the respective subject.

Zinc transport kinetics

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Apparently healthy men
• Body mass index between 18 and 30 kg/m2
• Willing to eat only the foods provided by the study for a 2 week period

You may not qualify if:

• Those reporting any chronic or acute diseases, food allergies, smoking or alcohol abuse
• 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
• Unable to refrain from taking medications during the study period

Sponsors & Collaborators

• UCSF Benioff Children's Hospital Oakland: lead

Study Sites (1)

Children's Hospital and Research Center Oakland

Oakland, California, 94609, United States

Location

Related Publications (3)

• Chung CS, Stookey J, Dare D, Welch R, Nguyen TQ, Roehl R, Peerson JM, King JC, Brown KH. Current dietary zinc intake has a greater effect on fractional zinc absorption than does longer term zinc consumption in healthy adult men. Am J Clin Nutr. 2008 May;87(5):1224-9. doi: 10.1093/ajcn/87.5.1224.

  PMID: 18469243 BACKGROUND

• Tran CD, Miller LV, Krebs NF, Lei S, Hambidge KM. Zinc absorption as a function of the dose of zinc sulfate in aqueous solution. Am J Clin Nutr. 2004 Dec;80(6):1570-3. doi: 10.1093/ajcn/80.6.1570.

  PMID: 15585770 BACKGROUND

• Sauer AK, Pfaender S, Hagmeyer S, Tarana L, Mattes AK, Briel F, Kury S, Boeckers TM, Grabrucker AM. Characterization of zinc amino acid complexes for zinc delivery in vitro using Caco-2 cells and enterocytes from hiPSC. Biometals. 2017 Oct;30(5):643-661. doi: 10.1007/s10534-017-0033-y. Epub 2017 Jul 17.

  PMID: 28717982 BACKGROUND

Study Officials

• Andrew G Hall, Ph.D.

  UCSF Benioff Children's Hospital Oakland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects are not informed of the amount of zinc in each test diet, or the order of the diets. The basic foods making up the test diets are identical in appearance and amount on each of the oral zinc stable isotope tracer days, so there is no way for the subject to distinguish any differences in the amount or form of zinc given.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nonlinear regression of fractional zinc absorption from 3 test diets using the Hill transport equation, and determination of an unknown amount of zinc based on fractional absorption from a single test diet. Order of the four test diets is randomized, with the constraint that the same oral zinc stable isotope tracer is not given on consecutive days.

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 1, 2019
• Study Start: June 10, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

US (1)