Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

Inflammation Clinical Trial

Official title:

Effect of Zinc-Biofortified Wheat on Essential Fatty Acid Metabolism in Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03451214
• Other study ID #: CHO22
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 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 effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Inflammation
• Oxidative Stress

Intervention

Other:
• Diet Zinc
4 mg zinc from zinc biofortified wheat, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period

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	Lipidomics changes	Change in Fatty acid metabolism	Day 0, day 15, day 57 and day 71
Primary	DNA strand breaks changes	change in COMET assay olive-tail moments	Day 0, day 15, day 57 and day 71
Secondary	Polar Metabolomics changes	Change in Polar Metabolomics	Day 0, day 15, day 57 and day 71
Secondary	Mineral analysis changes	Changes in Plasma Zinc	Day 0, day 15, day 57 and day 71
Secondary	Body weight changes	changes in Body weight	Day 0, day 15, day 57 and day 71
Secondary	Fat allocation changes	Changes in waist circumference	Day 0, day 15, day 57 and day 71