Zinc Supplement Before or With Food in Generally Healthy Men

Not Applicable

Completed

• Conditions: Zinc Deficiency; Inflammation; Dyslipidemias; Zinc Excess
• Interventions: Dietary Supplement: Zinc supplement

• Registration Number: NCT03619421
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-02
• Study First Submitted QC: 2018-08-02
• Study First Posted: 2018-08-07
• Study Start: 2018-08-21
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
supplement prior to food	Zinc supplement	Zinc supplement to be taken 30-min before breakfast consumption
Supplement with food	Zinc supplement	Zinc supplement to be taken at time of breakfast consumption

Primary Outcome Measures

Name	Time	Method
Plasma Zinc changes	Day 0, Day 15	Change in plasma zinc

Secondary Outcome Measures

Name	Time	Method
Body weight changes	Day 0, Day 15	Body weight changes
Essential Fatty acid changes	Day 0, Day 15	Essential Fatty acid changes
Blood glucose changes	Day 0, Day 15	Blood glucose changes

Trial Locations

Locations (1)

UCSF Benioff Children's Hospital Oakland Research Institute; 🇺🇸 Oakland, California, United States