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
The purpose of this study is to determine the effect of different dietary zinc intakes on fatty acid metabolism and other zinc biomarkers
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.
1,247 studies on the registry are indexed under Dyslipidemias; 175 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 986 interventional studies indexed under Dyslipidemias.
Browse Dyslipidemias studies →UCSF Benioff Children's Hospital Oakland is the lead sponsor of 55 studies on the registry; none are open to participants now.
Compared within Dyslipidemias, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Inflammation. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Lipidomics changes
Change in Fatty acid metabolism
Time frame: Day 0, day 15, day 57 and day 71
DNA strand breaks changes
change in COMET assay olive-tail moments
Time frame: Day 0, day 15, day 57 and day 71
Polar Metabolomics changes
Change in Polar Metabolomics
Time frame: Day 0, day 15, day 57 and day 71
Mineral analysis changes
Changes in Plasma Zinc
Time frame: Day 0, day 15, day 57 and day 71
Body weight changes
changes in Body weight
Time frame: Day 0, day 15, day 57 and day 71
Fat allocation changes
Changes in waist circumference
Time frame: Day 0, day 15, day 57 and day 71
Plan to share: No
Ran from Jul 2017 to primary completion in Jun 2018, 11 months.
Of 194 non-industry interventional studies with no phase under Dyslipidemias, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 42. This study's 11 months is below that.
Counting every sponsor, half of 205 studies reached it within 16 months; a quarter within 8 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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UCSF Benioff Children's Hospital Oakland