Trace Mineral Supplement for Dehydration

(TRACE Trial)

Overseen By Vivian Cervantes, BS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Thyroid medication

Disqualifiers: Pregnancy, Cardiovascular, Renal, Hepatic, others

Compensation: Varies

Number of Visits: 3

15 Participants Needed

Trial Summary

What is the purpose of this trial?

It is well established that post-exercise rehydration with electrolyte solutions is more effective than plain water. However, most commercially available drinks are high in electrolytes but lack some essential trace minerals. This study aims to examine the impact of a higher-electrolyte sports drink compared with a low-electrolyte, trace-mineral-rich solution and water on the time course and extent of rehydration after exercise-induced dehydration.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on thyroid medication.

What data supports the effectiveness of the treatment ConcenTrace for dehydration?

Research shows that magnesium supplementation, a component of ConcenTrace, has been studied for its advantages in treating diarrheal dehydration. Additionally, oral rehydration solutions, which often contain trace minerals like those in ConcenTrace, have been effective in reducing dehydration and preventing complications in children with diarrhea. ^{1 2 3 4 5}

Is the trace mineral supplement generally safe for humans?

Zinc supplementation, which is a component of trace mineral supplements, has been shown to be safe in humans. It is used in treating diarrhea and does not interfere with oral rehydration, and any deficiency symptoms can be reversed with proper supplementation. ^{6 7 8 9 10}

How does the treatment ConcenTrace differ from other treatments for dehydration?

ConcenTrace is unique because it focuses on replenishing trace minerals, which are often overlooked in standard dehydration treatments that primarily address fluid and major electrolyte (like sodium and potassium) imbalances. This approach may help restore essential trace elements like magnesium and manganese, which can be disrupted during dehydration. ^{1 4 11 12 13}

Eligibility Criteria

This trial is for people who exercise regularly (2-6 hours per week), have maintained a stable weight, and have a BMI of 18.5-29.9. It's not for those in other studies, heavy drinkers, night shift workers, smokers, or with certain health conditions like kidney or liver disease.

Inclusion Criteria

Recreationally physically active: Training > 2x per week and ≤ 6 hours per week

Stable weight for the last 2 months (<5 pounds fluctuation)

My BMI is between 18.5 and 29.9.

Exclusion Criteria

Participating in another study at the same time

High alcohol intake (average of > 2 standard drinks per day or > 10 standard drinks per week)

Night shifting work

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Dehydration

Participants undergo mild exercise and heat exposure to achieve 2% body weight loss

1 day

1 visit (in-person)

Rehydration

Participants consume one of three drinks to assess rehydration effectiveness

4 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after rehydration

1 day

Treatment Details

Interventions

• ConcenTrace

Trial Overview The study compares the effectiveness of ZeroLyte (a high-electrolyte sports drink), ConcenTrace (a trace-mineral-rich solution), and plain water in rehydrating individuals after exercise-induced dehydration.

Participant Groups

Group I: ZeroLyte Experimental Treatment 1 Intervention

Beverage with high level of trace elements but no sugar

Group II: ConcenTrace Experimental Treatment 1 Intervention

Beverage with ConcenTrace minerals

Group III: Placebo Placebo Group 1 Intervention

Water with non caloric, non-sodium containing sweetner

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of diarrheal dehydration. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

The use of oral hydration in the treatment of children with acute diarrhea in primary care. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a new hypotonic oral rehydration solution containing zinc and prebiotics in the treatment of childhood acute diarrhea: a randomized controlled trial. [2013]

4. Ukraine pubmed.ncbi.nlm.nih.gov

[Disordered water-mineral metabolism in cholera patients]. [2016]

5. China pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of reduced osmolarity oral rehydration salts in treatment of dehydration in children with acute diarrhea--a multicenter, randomized, double blind clinical trial]. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Zinc inhibits cholera toxin-induced, but not Escherichia coli heat-stable enterotoxin-induced, ion secretion in human enterocytes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Associations between intestinal mucosal function and changes in plasma zinc concentration following zinc supplementation. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Dietary model for production of experimental zinc deficiency in man. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Zinc supplementation in acute diarrhea is acceptable, does not interfere with oral rehydration, and reduces the use of other medications: a randomized trial in five countries. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

Efficacy of zinc-fortified oral rehydration solution in 6- to 35-month-old children with acute diarrhea. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Parenteral trace element provision: recent clinical research and practical conclusions. [2019]

12. South Africa pubmed.ncbi.nlm.nih.gov

Trace element concentrations in commonly used intravenous fluids. [2014]

13. United States pubmed.ncbi.nlm.nih.gov

Daily magnesium supplementation on serum and urinary magnesium changes in rats during prolonged restriction of motor activity. [2019]