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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different forms of zinc supplements affect the body, particularly the process of fatty acid desaturation, a step in fat metabolism. Researchers compare zinc combined with amino acids (Zinc Amino Acid, ZnAA) to zinc combined with gluconate to determine which is better absorbed and utilized by the body. They test whether taking these supplements on an empty stomach alters zinc processing. Men who are generally healthy, not on special diets or medications, and willing to take zinc supplements for four weeks may be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to foundational research on zinc supplementation and its effects on metabolism.

Do I need to stop taking my current medications for the trial?

If you are taking vitamins or supplements, including minerals and omega oils, you will need to stop taking them two weeks before the study and for the entire duration of the study. The protocol does not specify about other medications, but you should discuss this with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A study found that taking zinc as a zinc amino acid (ZnAA) complex did not significantly affect death rates in either early or later stages, suggesting that ZnAA is generally safe. Another study found that ZnAA supplements improved certain health aspects, such as reducing muscle problems and enhancing meat quality in animals, without any reported negative effects.

Research shows that zinc gluconate is safe at recommended doses. Although high doses over a long period can weaken immunity, normal use does not show significant problems. A trial with zinc gluconate in patients on dialysis found it improved sleep quality and health markers without negative effects.

Overall, studies have shown that both ZnAA and zinc gluconate are safe and well-tolerated. However, following dosage recommendations is crucial to avoid potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for zinc deficiency because they explore new ways of delivering zinc to the body. Zinc Amino Acid (ZnAA) combines zinc with the amino acids lysine and glutamate, which may improve absorption and utilization in the body compared to other forms, like zinc gluconate. On the other hand, zinc gluconate, a common form of zinc supplement, pairs zinc with gluconate to facilitate absorption. By comparing these two forms, researchers hope to discover which method is more effective at addressing zinc deficiency, potentially leading to more efficient treatment options.

What evidence suggests that this trial's treatments could be effective for zinc deficiency?

This trial will compare Zinc Amino Acid (ZnAA) with Zinc Gluconate for treating zinc deficiency. Research has shown that zinc amino acid complexes might be better absorbed by the body than traditional zinc supplements like zinc salts. Studies, particularly those involving animals, suggest these complexes can aid growth and nutrient utilization. Conversely, zinc gluconate is also well-absorbed and can effectively raise zinc levels in the blood, improving appetite and certain health indicators. Both types of zinc are absorbed well, but zinc amino acid complexes might mimic the body's natural processes more closely, potentially making them more effective in delivering zinc where it's needed. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6043427/

Effects of zinc sources and levels of zinc amino acid ... Supplementation with 20 to 80 mg/kg Zn from ZnAA improved the growth performance in weaned pigs. The piglets can tolerate up to 800 mg/kg Zn from ZnAA with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5646115/

Characterization of zinc amino acid complexes for ... We conclude that ZnAAs may possess an advantage over classical Zn supplements such as Zn salts, as they may be able to increase bioavailability of Zn.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0304423824007489

Organic Zn and nano-Zn amino acids chelates modulate ... Zinc biofortification increase nutritional content of crops to combat Zn deficiency in human diets. Foliar Zn bio-organics can significantly ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0311813

Evaluating the effect of optimal zinc amino-acid complex ... The Zn-AAC supplementation had significant effects on average daily gain (ADG), average daily feed intake (ADFI), and feed convention ratio (FCR) ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1161030112001451

The effectiveness of foliar applications of synthesized zinc ... Foliar application of Zn fertilizers resulted in significant decrease (on average 17.9%) of grain phytic acid (PA) and PA:Zn molar ratio (on average 16.3%) in ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2161831322011024

Discovery of Human Zinc Deficiency: Its Impact on ... Major clinical problems resulting from zinc deficiency in humans include growth retardation; cell-mediated immune dysfunction, and cognitive impairment.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06348056

A Comparison of the Metabolic Effects of Zinc-Amino Acid ... 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12163348/

Effects of Zinc Amino Acid Complex Supplementation on ... ZnAA supplementation significantly reduced myopathy incidence and improved footpad health, whilst enhancing the dry matter and protein content of broiler meat.

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.717064/full

Mechanistic Impact of Zinc Deficiency in Human ... Micro-nutrient deficiencies, such as Zn, greatly contribute to a number of diseases and lead toward adverse functional disorders, such as ...