Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

Not Applicable

Completed

• Conditions: Inflammation; Dyslipidemias; Oxidative Stress
• Interventions: Other: Diet Zinc

• Registration Number: NCT03451214
• Lead Sponsor: UCSF Benioff Children's Hospital Oakland

Brief Summary

The purpose of this study is to determine the effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers

Detailed Description

This research is a dietary intervention study designed to evaluate the effect of progressive changes in Zn intake on fatty acid metabolism and to correlate those changes with biomarkers of dyslipidemia and insulin resistance. The main objective is to validate plasma fatty acid metabolism as a biomarker of inadequate Zn intake in subjects consuming identical diets with specific Zn content. The relative sensitivity of some fatty acid enzyme activities will also be compared to the DNA strand breaks. 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. Similar correlational analyses will be performed with clinical measures of inflammation and insulin resistance.

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-28
• Study First Posted: 2018-03-01
• Status Verified: 2018-04
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Last Update Submitted: 2018-08-13
• Last Update Posted: 2018-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• willing to limit food and beverage intake to that provided by the study
• willing to discontinue consumption of alcoholic beverages during the study
• willing to stop zinc 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

Exclusion Criteria

• Chronic or acute metabolic disease
• smoker or user of nicotine products
• history of alcohol abuse, or use of illicit drugs.
• Is underweight or overweight, body mass index (BMI) < 18 or > 30 kg/m2.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
diet zinc	Diet Zinc	3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d

Primary Outcome Measures

Name	Time	Method
Lipidomics changes	Day 0, day 15, day 57 and day 71	Change in Fatty acid metabolism
DNA strand breaks changes	Day 0, day 15, day 57 and day 71	change in COMET assay olive-tail moments

Secondary Outcome Measures

Name	Time	Method
Polar Metabolomics changes	Day 0, day 15, day 57 and day 71	Change in Polar Metabolomics
Mineral analysis changes	Day 0, day 15, day 57 and day 71	Changes in Plasma Zinc
Body weight changes	Day 0, day 15, day 57 and day 71	changes in Body weight
Fat allocation changes	Day 0, day 15, day 57 and day 71	Changes in waist circumference

Trial Locations

Locations (1)

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