Zinc Supplement Before or With Food in Generally Healthy Men

Inflammation Clinical Trial

Official title:

Evaluation of Zinc Supplementation Taken Prior or With Food

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619421
• Other study ID #: CHO23
• Status: Completed
• Phase: N/A
• Start date: August 21, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: August 2018
• Source: Children's Hospital & Research Center Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemias
• Inflammation
• Zinc Deficiency
• Zinc Excess

Intervention

Dietary Supplement:
• Zinc supplement
25 mg

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital Oakland Research Institute	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital & Research Center Oakland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Zinc changes	Change in plasma zinc	Day 0, Day 15
Secondary	Body weight changes	Body weight changes	Day 0, Day 15
Secondary	Essential Fatty acid changes	Essential Fatty acid changes	Day 0, Day 15
Secondary	Blood glucose changes	Blood glucose changes	Day 0, Day 15