Zinc Supplement Before or With Food in Generally Healthy Men | NCT03619421

Studies
Zinc Supplement Before or With Food in Generally Healthy Men

NCT03619421

Sponsor

UCSF Benioff Children's Hospital Oakland

Status

Completed

Last Update Posted

May 1, 2019Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Zinc Deficiency
Dyslipidemias
Zinc Excess
Inflammation

Interventions

Zinc supplement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 21, 2018Actual

Primary Completion Date

Apr 15, 2019Actual

Completion Date

Apr 15, 2019Actual

First Submitted Date

Aug 2, 2018

First Submission Date that Met QC Criteria

Aug 2, 2018

First Posted Date

Aug 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2019

Last Update Posted Date

May 1, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Supplement with food	Experimental	Zinc supplement to be taken at time of breakfast consumption	Dietary Supplement: Zinc supplement
supplement prior to food	Experimental	Zinc supplement to be taken 30-min before breakfast consumption	Dietary Supplement: Zinc supplement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Zinc supplement	Dietary Supplement	25 mg	Supplement with food supplement prior to food

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Body weight changes	Body weight changes	Day 0, Day 15
Essential Fatty acid changes	Essential Fatty acid changes	Day 0, Day 15

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jung Suh, PhD	UCSF Benioff Children's Hospital Oakland Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Benioff Children's Hospital Oakland Research Institute		Oakland	California	94609	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34236435	Derived	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.

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

ID	Term
D050171	Dyslipidemias
D007249	Inflammation