Evaluation of Zinc Intake on Essential Fatty Acid Metabolism
Primary Purpose
Inflammation, Oxidative Stress, Dyslipidemias
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet Zinc
Sponsored by
About this trial
This is an interventional basic science trial for Inflammation
Eligibility Criteria
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.
Sites / Locations
- UCSF Benioff Children's Hospital Oakland Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
diet zinc
Arm Description
3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d
Outcomes
Primary Outcome Measures
Lipidomics changes
Change in Fatty acid metabolism
DNA strand breaks changes
change in COMET assay olive-tail moments
Secondary Outcome Measures
Polar Metabolomics changes
Change in Polar Metabolomics
Mineral analysis changes
Changes in Plasma Zinc
Body weight changes
changes in Body weight
Fat allocation changes
Changes in waist circumference
Full Information
NCT ID
NCT03451214
First Posted
February 9, 2018
Last Updated
August 13, 2018
Sponsor
UCSF Benioff Children's Hospital Oakland
1. Study Identification
Unique Protocol Identification Number
NCT03451214
Brief Title
Evaluation of Zinc Intake on Essential Fatty Acid Metabolism
Official Title
Effect of Zinc-Biofortified Wheat on Essential Fatty Acid Metabolism in Men
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCSF Benioff Children's Hospital Oakland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Oxidative Stress, Dyslipidemias
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diet zinc
Arm Type
Experimental
Arm Description
3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d
Intervention Type
Other
Intervention Name(s)
Diet Zinc
Intervention Description
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 Outcome Measure Information:
Title
Lipidomics changes
Description
Change in Fatty acid metabolism
Time Frame
Day 0, day 15, day 57 and day 71
Title
DNA strand breaks changes
Description
change in COMET assay olive-tail moments
Time Frame
Day 0, day 15, day 57 and day 71
Secondary Outcome Measure Information:
Title
Polar Metabolomics changes
Description
Change in Polar Metabolomics
Time Frame
Day 0, day 15, day 57 and day 71
Title
Mineral analysis changes
Description
Changes in Plasma Zinc
Time Frame
Day 0, day 15, day 57 and day 71
Title
Body weight changes
Description
changes in Body weight
Time Frame
Day 0, day 15, day 57 and day 71
Title
Fat allocation changes
Description
Changes in waist circumference
Time Frame
Day 0, day 15, day 57 and day 71
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung Suh, PhD
Organizational Affiliation
Associate Staff Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospital Oakland Research Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34036355
Citation
Liong EM, McDonald CM, Suh J, Westcott JL, Wong CP, Signorell C, King JC. Zinc-Biofortified Wheat Intake and Zinc Status Biomarkers in Men: Randomized Controlled Trial. J Nutr. 2021 Jul 1;151(7):1817-1823. doi: 10.1093/jn/nxab092.
Results Reference
derived
Learn more about this trial
Evaluation of Zinc Intake on Essential Fatty Acid Metabolism
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