Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

August 13, 2018 updated by: UCSF Benioff Children's Hospital Oakland

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94609
        • UCSF Benioff Children's Hospital Oakland Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: diet zinc
3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lipidomics changes
Time Frame: Day 0, day 15, day 57 and day 71
Change in Fatty acid metabolism
Day 0, day 15, day 57 and day 71
DNA strand breaks changes
Time Frame: Day 0, day 15, day 57 and day 71
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
Time Frame: Day 0, day 15, day 57 and day 71
Change in Polar Metabolomics
Day 0, day 15, day 57 and day 71
Mineral analysis changes
Time Frame: Day 0, day 15, day 57 and day 71
Changes in Plasma Zinc
Day 0, day 15, day 57 and day 71
Body weight changes
Time Frame: Day 0, day 15, day 57 and day 71
changes in Body weight
Day 0, day 15, day 57 and day 71
Fat allocation changes
Time Frame: Day 0, day 15, day 57 and day 71
Changes in waist circumference
Day 0, day 15, day 57 and day 71

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCSF Benioff Children's Hospital Oakland

Investigators

  • Principal Investigator: Jung Suh, PhD, Associate Staff Scientist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHO22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on Diet Zinc

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Austria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe