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Completed

NCT Number: NCT03451214

Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

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

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital Oakland Research Institute

Oakland, California, 94609, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diet Zinc

Other

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

Primary outcomes

  1. Lipidomics changes

    Time frame: Day 0, day 15, day 57 and day 71

    Change in Fatty acid metabolism

  2. DNA strand breaks changes

    Time frame: Day 0, day 15, day 57 and day 71

    change in COMET assay olive-tail moments

Secondary outcomes

  1. Polar Metabolomics changes

    Time frame: Day 0, day 15, day 57 and day 71

    Change in Polar Metabolomics

  2. Mineral analysis changes

    Time frame: Day 0, day 15, day 57 and day 71

    Changes in Plasma Zinc

  3. Body weight changes

    Time frame: Day 0, day 15, day 57 and day 71

    changes in Body weight

  4. Fat allocation changes

    Time frame: Day 0, day 15, day 57 and day 71

    Changes in waist circumference

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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