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Completed

NCT Number: NCT03619421

Zinc Supplement Before or With Food in Generally Healthy Men

The purpose of this study is to determine the influence of food consumption timing on the body's response to a zinc supplement

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Key information

Conditions

Zinc Deficiency Dyslipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Zinc Excess

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UCSF Benioff Children's Hospital Oakland Research Institute

Oakland, California, 94609, United States

About this study

This research is a dietary intervention study designed to evaluate the effect of the food consumption timing on the absorption of zinc supplement.

The main objective is to measure plasma zinc in generally healthy male subjects, who will consume zinc supplement with food or 30-min before food for 2-weeks.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • willing to stop 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
  • regularly eat breakfast

Exclusion criteria

  • Chronic or acute metabolic disease
  • smoker or user of nicotine products
  • history of alcohol abuse, or use of illicit drugs (incl marijuana)
  • Is underweight or overweight, body mass index (BMI) < 18 or > 30 kg/m2

Treatment and study plan

Zinc Supplement

Dietary Supplement

25 mg

Primary outcomes

  1. Plasma Zinc changes

    Time frame: Day 0, Day 15

    Change in plasma zinc

Secondary outcomes

  1. Body weight changes

    Time frame: Day 0, Day 15

    Body weight changes

  2. Essential Fatty acid changes

    Time frame: Day 0, Day 15

    Essential Fatty acid changes

  3. Blood glucose changes

    Time frame: Day 0, Day 15

    Blood glucose changes

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Registry information

Official study title

Evaluation of Zinc Supplementation Taken Prior or With Food

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 7, 2018
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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