Zinc Supplement Before or With Food in Generally Healthy Men

April 29, 2019 updated by: UCSF Benioff Children's Hospital Oakland

Evaluation of Zinc Supplementation Taken Prior or With Food

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

35

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

  • United States
    • California
      • Oakland, California, United States, 94609
        • UCSF Benioff Children's Hospital Oakland Research Institute

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

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supplement with food
Zinc supplement to be taken at time of breakfast consumption
Dietary supplement: Zinc supplement
25 mg
Experimental: supplement prior to food
Zinc supplement to be taken 30-min before breakfast consumption
Dietary supplement: Zinc supplement
25 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Zinc changes
Time Frame: Day 0, Day 15
Change in plasma zinc
Day 0, Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight changes
Time Frame: Day 0, Day 15
Body weight changes
Day 0, Day 15
Essential Fatty acid changes
Time Frame: Day 0, Day 15
Essential Fatty acid changes
Day 0, Day 15
Blood glucose changes
Time Frame: Day 0, Day 15
Blood glucose changes
Day 0, Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Investigators

  • Principal Investigator: Jung Suh, PhD, UCSF Benioff Children's Hospital Oakland Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 21, 2018

Primary Completion (Actual)

April 15, 2019

Study Completion (Actual)

April 15, 2019

Study Registration Dates

First Submitted

August 2, 2018

First Submitted That Met QC Criteria

August 2, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHO23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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