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临床试验/NCT03934346
NCT03934346已完成不适用

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

UCSF Benioff Children's Hospital Oakland2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
2
主要终点
Zinc Transport Curve

研究概览

简要总结

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.

详细描述

An experimentally-determined value for any pre-absorptive dissociation of zinc from ZnAA is necessary for the accurate compartmental modeling of zinc metabolism when provided as ZnAA compared with zinc chloride, which the investigators will perform in a future study.

The current study will allow us to determine the pre-absorptive 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. Since zinc absorption kinetics follow a saturable process, the zinc transport maximum (Tr_max) and transport rate (K_Tr) can be determined by fitting Hill transport equation to measurements of absorbed zinc at 3 or more levels of zinc intake (mg zinc/d):

Total Absorbed Zinc (TAZ) = (Zinc Intake * Tr_max) / (Zinc Intake + K_Tr)

Although population data have been used to estimate zinc transport kinetics (Tran, et al. AJCN 2004), Tr_max and K_tr have never been determined in individual subjects. The investigators plan to determine the fractional zinc absorption (FZA) from multiple levels of dietary zinc in rapid succession (Chung, et al. AJCN 2004) and, therefore, estimate an individual's transport maximum and rate, Tr_max and K_Tr. Once Tr_max and K_Tr are known, the FZA can be used to determine an unknown zinc intake from zinc chloride and any zinc dissociated from the ZnAA complex using the following equation:

Zinc Intake = (Tr_max / FZA) - K_Tr

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

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.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Zinc Transport Curve

时间窗: 2 weeks

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

Dissociated Amino Acid Zinc

时间窗: 2 weeks

Amount of zinc dissociated from the ZnAA prior to absorption

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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