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Zinc Supplement Before or With Food in Generally Healthy Men

Primary Purpose

Zinc Deficiency, Dyslipidemias, Zinc Excess

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zinc supplement
Sponsored by
UCSF Benioff Children's Hospital Oakland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Zinc Deficiency focused on measuring zinc, nutrition, supplement, food

Eligibility Criteria

18 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • UCSF Benioff Children's Hospital Oakland Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Supplement with food

supplement prior to food

Arm Description

Zinc supplement to be taken at time of breakfast consumption

Zinc supplement to be taken 30-min before breakfast consumption

Outcomes

Primary Outcome Measures

Plasma Zinc changes
Change in plasma zinc

Secondary Outcome Measures

Body weight changes
Body weight changes
Essential Fatty acid changes
Essential Fatty acid changes
Blood glucose changes
Blood glucose changes

Full Information

First Posted
August 2, 2018
Last Updated
April 29, 2019
Sponsor
UCSF Benioff Children's Hospital Oakland
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1. Study Identification

Unique Protocol Identification Number
NCT03619421
Brief Title
Zinc Supplement Before or With Food in Generally Healthy Men
Official Title
Evaluation of Zinc Supplementation Taken Prior or With Food
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 21, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zinc Deficiency, Dyslipidemias, Zinc Excess, Inflammation
Keywords
zinc, nutrition, supplement, food

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Random number used to label samples
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supplement with food
Arm Type
Experimental
Arm Description
Zinc supplement to be taken at time of breakfast consumption
Arm Title
supplement prior to food
Arm Type
Experimental
Arm Description
Zinc supplement to be taken 30-min before breakfast consumption
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc supplement
Intervention Description
25 mg
Primary Outcome Measure Information:
Title
Plasma Zinc changes
Description
Change in plasma zinc
Time Frame
Day 0, Day 15
Secondary Outcome Measure Information:
Title
Body weight changes
Description
Body weight changes
Time Frame
Day 0, Day 15
Title
Essential Fatty acid changes
Description
Essential Fatty acid changes
Time Frame
Day 0, Day 15
Title
Blood glucose changes
Description
Blood glucose changes
Time Frame
Day 0, Day 15

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Suh, PhD
Organizational Affiliation
UCSF Benioff Children's Hospital Oakland Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospital Oakland Research Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34236435
Citation
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.
Results Reference
derived

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Zinc Supplement Before or With Food in Generally Healthy Men

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