NCT03619421

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

August 21, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed
Last Updated

May 1, 2019

Status Verified

August 1, 2018

Enrollment Period

8 months

First QC Date

August 2, 2018

Last Update Submit

April 29, 2019

Conditions

Keywords

zincnutritionsupplementfood

Outcome Measures

Primary Outcomes (1)

  • Plasma Zinc changes

    Change in plasma zinc

    Day 0, Day 15

Secondary Outcomes (3)

  • Body weight changes

    Day 0, Day 15

  • Essential Fatty acid changes

    Day 0, Day 15

  • Blood glucose changes

    Day 0, Day 15

Study Arms (2)

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

Zinc supplementDIETARY_SUPPLEMENT

25 mg

Supplement with foodsupplement prior to food

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Benioff Children's Hospital Oakland Research Institute

Oakland, California, 94609, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DyslipidemiasInflammation

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jung Suh, PhD

    UCSF Benioff Children's Hospital Oakland Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Random number used to label samples
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 7, 2018

Study Start

August 21, 2018

Primary Completion

April 15, 2019

Study Completion

April 15, 2019

Last Updated

May 1, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations