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Zinc Supplement Before or With Food in Generally Healthy Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03619421
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Description
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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

Condition or disease Intervention/treatment Phase
Zinc Deficiency Dyslipidemias Zinc Excess Inflammation Dietary Supplement: Zinc supplement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Random number used to label samples
Primary Purpose: Basic Science
Official Title: Evaluation of Zinc Supplementation Taken Prior or With Food
Actual Study Start Date : August 21, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Plasma Zinc changes [ Time Frame: Day 0, Day 15 ]
    Change in plasma zinc


Secondary Outcome Measures :
  1. Body weight changes [ Time Frame: Day 0, Day 15 ]
    Body weight changes

  2. Essential Fatty acid changes [ Time Frame: Day 0, Day 15 ]
    Essential Fatty acid changes

  3. Blood glucose changes [ Time Frame: Day 0, Day 15 ]
    Blood glucose changes


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619421


Locations
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United States, California
UCSF Benioff Children's Hospital Oakland Research Institute
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
Investigators
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Principal Investigator: Jung Suh, PhD UCSF Benioff Children's Hospital Oakland Research Institute
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT03619421    
Other Study ID Numbers: CHO23
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UCSF Benioff Children's Hospital Oakland:
zinc
nutrition
supplement
food
Additional relevant MeSH terms:
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Dyslipidemias
Inflammation
Pathologic Processes
Lipid Metabolism Disorders
Metabolic Diseases