CClinicalTrials.gg
CompletedNCT03451214Updated Aug 14, 2018

Evaluation of Zinc Intake on Essential Fatty Acid Metabolism

An interventional study of Diet Zinc in Inflammation, Oxidative Stress and Dyslipidemias, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by UCSF Benioff Children's Hospital Oakland · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Inflammation
  • Oxidative Stress
  • Dyslipidemias
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    diet zinc

    3 dietary zinc levels: 6 mg/d, 11 mg/d and 25 mg supplemental zinc/d

    Other: Diet Zinc

Interventions

  • OtherDiet 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

05

What researchers measure

Primary outcomes

  1. Lipidomics changes

    Change in Fatty acid metabolism

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

  2. DNA strand breaks changes

    change in COMET assay olive-tail moments

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

Secondary outcomes

  1. Polar Metabolomics changes

    Change in Polar Metabolomics

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

  2. Mineral analysis changes

    Changes in Plasma Zinc

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

  3. Body weight changes

    changes in Body weight

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

  4. Fat allocation changes

    Changes in waist circumference

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

06

Study locations

1 site
  • UCSF Benioff Children's Hospital Oakland Research Institute
    Oakland, California 94609, United States
07

References and documents

Publications

  • 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. PubMed 34036355 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03451214
Lead sponsor
UCSF Benioff Children's Hospital Oakland
Responsible party
Sponsor
First posted
Mar 1, 2018
Start date
Jul 1, 2017
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Aug 14, 2018

Study contacts

Jung Suh, PhD
principal investigator · Associate Staff Scientist

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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