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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different drinks aid rehydration after exercise. Researchers aim to determine if a drink with more trace minerals enhances rehydration better than regular sports drinks or plain water. Participants will consume one of three drinks: a mineral-rich drink called ConcenTrace, a no-sugar trace-element drink called ZeroLyte, or water with a sweetener. It suits individuals who exercise regularly, train more than twice a week, and maintain a stable weight. As an unphased trial, this study provides a unique opportunity to contribute to understanding optimal rehydration methods for active individuals.

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.

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

A previous study found that ConcenTrace, a supplement with trace minerals, showed no significant effects or major risks, indicating it is generally safe when taken in recommended amounts. However, excessive intake could be harmful, as excess trace minerals might cause health issues.

For ZeroLyte, a drink mix with electrolytes and trace minerals, no evidence of serious side effects exists. Some reports suggest slight irritation might occur if it contacts the eyes or is inhaled, but this is not a concern when consumed as intended.

Both treatments appear safe and well-tolerated when used correctly. Always follow the recommended dosages to avoid potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the treatments ConcenTrace and ZeroLyte for dehydration because they offer innovative approaches compared to traditional oral rehydration solutions. Unlike standard treatments that often rely on sugar and electrolytes like sodium and potassium, ConcenTrace delivers a beverage rich in trace minerals, which are essential for various body functions and might enhance hydration at a cellular level. ZeroLyte, on the other hand, provides a unique option with high levels of trace elements but no sugar, potentially offering a healthier alternative for those needing to manage sugar intake. Both treatments aim to improve hydration effectiveness, potentially offering a quicker and more balanced recovery from dehydration.

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

This trial will compare the effects of ConcenTrace and ZeroLyte on hydration. Research has shown that trace minerals are important for maintaining hydration. ConcenTrace, one treatment in this trial, is a mineral-rich solution that has been found to support bone and joint health. Although specific data on dehydration is limited, the minerals in ConcenTrace may aid rehydration by replacing nutrients lost during exercise. ZeroLyte, another treatment option, is an electrolyte drink mix known for balancing body fluids and supporting muscle function. It contains a high level of potassium, which helps prevent dehydration and supports heart health. Both ConcenTrace and ZeroLyte contain ingredients that may improve hydration more effectively than water alone. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06122571

A Clinical Trial to Evaluate the Effect of ConcenTrace Trace ... Study Details | NCT06122571 | A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health | ClinicalTrials.gov.

2. withpower.com withpower.com/trial/phase-dehydration-2-2025-903bf

Trace Mineral Supplement for Dehydration (TRACE Trial) This trial aims to compare the effectiveness of a sports drink high in electrolytes with a low-electrolyte, trace-mineral-rich solution and plain water in ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6356561/

Narrative Review of Hydration and Selected Health ... Data consistently show a reduction of >2% in body mass due to dehydration results in effect on mood, fatigue, and alertness. Effects on cognition have been less ...

4. trialx.com trialx.com/clinical-trials/listings/227431/a-clinical-trial-to-evaluate-the-effect-of-concentrace-trace-mineral-drops-on-gut-health/

A Clinical Trial to Evaluate the Effect of ConcenTrace Trace ... Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in.

5. traceminerals.com traceminerals.com/blogs/nutrition/why-concentrace%C2%AE-trace-mineral-drops-is-our-best-selling-product?srsltid=AfmBOoo5mflHgog9YqbuvD9Uptishftwk9wVBnEhxHa3Ef7m68e_Njcz

Why ConcenTrace® Trace Mineral Drops Is Our Best ... Bone, Joint & Health–Taken as directed, many people have experienced dramatic results in improving and strengthening bones, joints and teeth, ...

6. uploads-ssl.webflow.com uploads-ssl.webflow.com/5e62782cdbb4cf45a4777d5b/5ed1216f592a1f86bcb67ba5_ConcenTrace-AC-ConcenTrace-AC-Granulated_TraceMinerals-SDS-US-V4.7English-US.pdf

SAFETY DATA SHEET ConcenTrace AC, ConcenTrace AC Granulated ... : No known significant effects or critical hazards. Persistence and degradability. Soil/water partition coefficient ...

7. everydayhealth.com everydayhealth.com/nutritional-supplements/side-effects-of-trace-mineral-supplements/

Side Effects of Trace Mineral Supplements Trace minerals are an important part of good health, but excess amounts from consuming a trace mineral supplement can bring about dangerous health risks.

8. amazon.com amazon.com/Trace-Minerals-Research-Concentrace-Mineral/dp/B000AMUWLK

Trace Minerals ConcenTrace Trace Mineral Drops This item is non-returnable due to potential safety risk as an ingestible product, but if the item arrives damaged or defective, you may request a refund or ...

9. traceminerals.com traceminerals.com/products/concentrace-trace-mineral-drops?srsltid=AfmBOooYvoOzhXB59vOCw78yaF6LDSGTVKz-vRyioumD8PnijWu_xzCU

ConcenTrace® Trace Mineral Drops Key Features: • Purest, highest-value liquid trace minerals on the market • We harvest our own ionic trace minerals from seawater