Zinc Supplement Before or With Food in Generally Healthy Men

NCT ID: NCT03619421

Last Updated: 2019-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-21

Study Completion Date

2019-04-15

Brief Summary

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The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

Detailed Description

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This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement.

The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks.

In addition to the primary objectives, correlations in enzyme activity with changes in fat metabolism, namely circulating triglyceride and cholesterol, will be determined. This will enable the determination of the effect of a low Zn intake on various aspects of dyslipidemia.

Conditions

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Zinc Deficiency Dyslipidemias Zinc Excess Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Random number used to label samples

Study Groups

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Supplement with food

Zinc supplement to be taken at time of breakfast consumption

Group Type EXPERIMENTAL

Zinc supplement

Intervention Type DIETARY_SUPPLEMENT

25 mg

supplement prior to food

Zinc supplement to be taken 30-min before breakfast consumption

Group Type EXPERIMENTAL

Zinc supplement

Intervention Type DIETARY_SUPPLEMENT

25 mg

Interventions

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Zinc supplement

25 mg

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* willing to stop supplementation 4 weeks prior to start of the study
* has an operative understanding of English
* no plans to move from the area during the study period
* regularly eat breakfast

Exclusion Criteria

* Chronic or acute metabolic disease
* smoker or user of nicotine products
* history of alcohol abuse, or use of illicit drugs (incl marijuana)
* Is underweight or overweight, body mass index (BMI) \< 18 or \> 30 kg/m2
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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UCSF Benioff Children's Hospital Oakland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jung Suh, PhD

Role: PRINCIPAL_INVESTIGATOR

UCSF Benioff Children's Hospital Oakland Research Institute

Locations

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UCSF Benioff Children's Hospital Oakland Research Institute

Oakland, California, United States

Site Status

Countries

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United States

References

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Massih YN, Hall AG, Suh J, King JC. Zinc Supplements Taken with Food Increase Essential Fatty Acid Desaturation Indices in Adult Men Compared with Zinc Taken in the Fasted State. J Nutr. 2021 Sep 4;151(9):2583-2589. doi: 10.1093/jn/nxab149.

Reference Type DERIVED
PMID: 34236435 (View on PubMed)

Other Identifiers

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CHO23

Identifier Type: -

Identifier Source: org_study_id

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