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Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03451214
Enrollment
40
Registered
2018-03-01
Start date
2017-07-01
Completion date
2018-06-30
Last updated
2018-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias, Inflammation, Oxidative Stress

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.

Interventions

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

Sponsors

UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Lipidomics changesDay 0, day 15, day 57 and day 71Change in Fatty acid metabolism
DNA strand breaks changesDay 0, day 15, day 57 and day 71change in COMET assay olive-tail moments

Secondary

MeasureTime frameDescription
Polar Metabolomics changesDay 0, day 15, day 57 and day 71Change in Polar Metabolomics
Mineral analysis changesDay 0, day 15, day 57 and day 71Changes in Plasma Zinc
Body weight changesDay 0, day 15, day 57 and day 71changes in Body weight
Fat allocation changesDay 0, day 15, day 57 and day 71Changes in waist circumference

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026