Evaluation of Zinc Intake on Essential Fatty Acid Metabolism
Effect of Zinc-Biofortified Wheat on Essential Fatty Acid Metabolism in Men
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedAugust 14, 2018
April 1, 2018
12 months
February 9, 2018
August 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Polar Metabolomics changes
Day 0, day 15, day 57 and day 71
Mineral analysis changes
Day 0, day 15, day 57 and day 71
Body weight changes
Day 0, day 15, day 57 and day 71
Fat allocation changes
Day 0, day 15, day 57 and day 71
Study Arms (1)
diet zinc
EXPERIMENTAL3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Benioff Children's Hospital Oakland Research Institute
Oakland, California, 94609, United States
Related Publications (1)
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.
PMID: 34036355DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jung Suh, PhD
Associate Staff Scientist
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2018
First Posted
March 1, 2018
Study Start
July 1, 2017
Primary Completion
June 30, 2018
Study Completion
June 30, 2018
Last Updated
August 14, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share