Zinc-Amino Acid vs Zinc Gluconate for Zinc Deficiency

Overseen By Janet C King, Ph.D.

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: University of California, Berkeley

Must not be taking: Blood thinners, Vitamins

Disqualifiers: Heart disease, Inflammatory disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Food consumption affects zinc metabolism within the body. Lowe and colleagues demonstrated that zinc is directed out of plasma and into tissues, such as into the liver, postprandially . It is likely that zinc absorbed with a meal is directed to the liver via the portal circulation whereas that zinc taken in the fasted state is more readily directed to peripheral blood plasma. Zinc taken with food is more likely to be bound to components of the food matrix and, therefore, it is not absorbed as efficiently by Zip4 ionic zinc transporters in the upper gastrointestinal tract. Some of the zinc in the food matrix may, however, be co-absorbed with amino acids over the whole length of the small intestine . Co-absorption of zinc with amino acids may explain the greater effects of zinc taken with food on omega-6 fatty acid desaturation . The investigators propose that this effect may be maximized by providing supplemental zinc complexed with amino acids. Since the zinc amino acid complex likely mimics the absorption and retention of zinc bound to protein in food, the investigators further propose that zinc, bound to amino acids taken in the fasted state will be directed into the cellular compartments more efficiently than zinc associated with gluconate. The primary aim in this study is to determine whether providing a zinc amino acid complex has a greater effect on indices of essential fatty acid desaturation compared with zinc gluconate when the zinc complexes are taken in the fasting state. The investigators hypothesize that taking a zinc amino acid (Zn-AA) complex in a fasted state daily for two weeks has a greater effect on the Fatty Acid Desaturase 1 (FADS1) activity compared with zinc gluconate. Also, if the uptake of ionic zinc gluconate into cellular compartments is reduced in comparison to Zn-AA because the zinc gluconate is retained in the plasma, two weeks of a daily zinc gluconate will have a greater effect on fasting plasma zinc concentrations compared to a Zn- AA complex.

Eligibility Criteria

This trial is for individuals who can safely take zinc supplements without risk of toxicity. Participants must be able to consume the supplements in a fasted state over a period of 13 days.

Inclusion Criteria

Body mass index between 18 and 30 kg/m2

Apparently healthy men (i.e., have no current health issues requiring medications or a specific diet)

I am willing to take zinc supplements for four weeks as provided by the study.

Exclusion Criteria

Smoking or alcohol abuse, use of illicit drugs

I have a history of heart disease, inflammatory disorders, cancer treatment, or HIV.

I cannot have blood drawn due to bleeding disorders or because I'm on blood thinners.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment Phase 1

Participants receive either zinc gluconate or zinc amino acid complex for 13 days in a fasted state

2 weeks

2 visits (in-person)

Washout

Participants undergo a washout period between crossover studies

2 weeks

Treatment Phase 2

Participants receive the alternate form of zinc for 13 days in a fasted state

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Zinc Amino Acid (ZnAA)
• Zinc Gluconate

Trial Overview The study compares the metabolic effects of two different forms of zinc supplementation: Zinc-Amino Acid (ZnAA) complex and Zinc Gluconate, taken without food to see which is better absorbed and utilized by the body.

Participant Groups

Group I: Zinc Gluconate Experimental Treatment 1 Intervention

The zinc in the supplement is complexed with gluconate.

Group II: Zinc Amino Acid Experimental Treatment 1 Intervention

The zinc in the supplement is complexed with the amino acids lysine and glutamate.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+