Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inflammation, Oxidative Stress, Dyslipidemias

Intervention / Treatment
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* Other: Diet Zinc


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet zinc<br>3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d | Other: Diet Zinc<br>* 4 mg zinc from zinc biofortified wheat, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipidomics changes | Change in Fatty acid metabolism | Day 0, day 15, day 57 and day 71 | 
| DNA strand breaks changes | change in COMET assay olive-tail moments | Day 0, day 15, day 57 and day 71 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polar Metabolomics changes | Change in Polar Metabolomics | Day 0, day 15, day 57 and day 71 | 
| Mineral analysis changes | Changes in Plasma Zinc | Day 0, day 15, day 57 and day 71 | 
| Body weight changes | changes in Body weight | Day 0, day 15, day 57 and day 71 | 
| Fat allocation changes | Changes in waist circumference | Day 0, day 15, day 57 and day 71 |