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Zinc Supplement Before or With Food in Generally Healthy Men

Sponsor
UCSF Benioff Children's Hospital Oakland (Other)
Overall Status
Completed
CT.gov ID
NCT03619421
Collaborator
(none)
35
Enrollment
1
Location
2
Arms
7.8
Actual Duration (Months)
4.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Zinc supplement
 N/A

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

Study Type:
Interventional
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 :
Aug 21, 2018
Actual Primary Completion Date :
Apr 15, 2019
Actual Study Completion Date :
Apr 15, 2019

Arms and Interventions

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

Primary Outcome Measures

  1. Plasma Zinc changes [Day 0, Day 15]

    Change in plasma zinc

Secondary Outcome Measures

  1. Body weight changes [Day 0, Day 15]

    Body weight changes

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

    Essential Fatty acid changes

  3. Blood glucose changes [Day 0, Day 15]

    Blood glucose changes

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 UCSF Benioff Children's Hospital Oakland Research Institute Oakland California United States 94609

Sponsors and Collaborators

  • UCSF Benioff Children's Hospital Oakland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier:
NCT03619421
Other Study ID Numbers:
  • CHO23
First Posted:
Aug 7, 2018
Last Update Posted:
May 1, 2019
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Dyslipidemias
Inflammation

Study Results

No Results Posted as of May 1, 2019