Clinical trial NCT03451214: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Oxidative Stress
Dyslipidemias
Lead sponsor: UCSF Benioff Children's Hospital Oakland
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Lipidomics changes
timeFrame: Day 0, day 15, day 57 and day 71
measure: DNA strand breaks changes
timeFrame: Day 0, day 15, day 57 and day 71
Secondary outcomes:
measure: Polar Metabolomics changes
timeFrame: Day 0, day 15, day 57 and day 71
measure: Mineral analysis changes
timeFrame: Day 0, day 15, day 57 and day 71
measure: Body weight changes
timeFrame: Day 0, day 15, day 57 and day 71
measure: Fat allocation changes
timeFrame: Day 0, day 15, day 57 and day 71
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland Research Institute
state: California
Study officials:
affiliation: Associate Staff Scientist
name: Jung Suh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.