OptiCreatine for Creatine Supplementation

Overseen By Abbie E. Smith-Ryan, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: TSI Group LTD

Must not be taking: Diuretics, Corticosteroids

Disqualifiers: Chronic kidney disease, Liver disease, others

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

Compensation: Varies

Number of Visits: 4

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests OptiCreatine, a new creatine supplement combined with other ingredients to improve absorption and reduce stomach issues. It compares OptiCreatine with regular creatine (creatine monohydrate) to determine which raises creatine levels in the blood more effectively, how they affect stomach comfort, and how they alter fluid levels in the body. Healthy adults who exercise at least 30 minutes a week and do not have kidney, liver, or lung diseases may be suitable candidates. Participants will take both supplements at different times to observe their body's reactions. As an unphased trial, this study provides an opportunity to contribute to understanding the benefits of new supplement combinations.

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

The trial requires you to stop taking certain medications like diuretics and corticosteroids, as they may affect the study's outcomes. If you're currently using creatine monohydrate, you also need to stop.

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

Studies have shown that creatine monohydrate is generally safe for most people and has been used for years to enhance exercise performance. Some individuals might experience mild side effects like stomach cramps or diarrhea, but these are usually not serious.

Regarding OptiCreatine, less research is available, but it combines creatine with other ingredients to improve absorption and reduce stomach issues. This combination suggests it might be gentler on the stomach than regular creatine. The trial's advanced phase indicates sufficient safety information to test it in healthy adults. Overall, both treatments appear safe for most people, with only minor side effects expected. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

OptiCreatine is unique because it combines creatine with other bioactive compounds to potentially enhance absorption, setting it apart from standard creatine monohydrate supplements. Most creatine supplements focus on delivering creatine alone, but OptiCreatine aims to improve how well the body absorbs and utilizes creatine. Researchers are excited about this treatment because it could lead to quicker and more effective results, providing an edge over traditional creatine options.

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

Research has shown that OptiCreatine, one of the treatments in this trial, might help the body absorb creatine more effectively and cause fewer stomach issues than regular creatine monohydrate, the other treatment arm in this trial. OptiCreatine combines creatine with other ingredients that enhance absorption. This could result in higher creatine levels in the blood and fewer digestive problems. Users of creatine monohydrate have experienced increased muscle energy and improved performance. OptiCreatine aims to deliver these benefits with added comfort and efficiency. ^{4 6 7 8 9}

Who Is on the Research Team?

John A Rathmacher, Ph.D.

Principal Investigator

TSI Group LTD

Are You a Good Fit for This Trial?

This trial is for healthy, recreationally active adults interested in the effects of creatine supplementation. Participants should be willing to consume two different forms of creatine orally and undergo tests measuring plasma levels and fluid distribution.

Inclusion Criteria

I am between 18 and 45 years old.

Body mass index of less than 35 kg/m2

Recreationally active (≥30 minutes of moderate-intensity physical activity per week as defined by the International Physical Activity Questionnaire)

Exclusion Criteria

Has severely impaired hearing or speech or inability to speak English

I have chronic kidney disease, liver disease, COPD, or cancer.

I am currently taking diuretics or corticosteroids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Phase

Participants are randomly assigned to consume either OptiCreatine or creatine monohydrate in a cross-over design. Blood samples are collected at various time points post-ingestion.

1 week

2 visits (in-person)

Chronic Phase

Participants undergo a 5-day creatine loading phase with either OptiCreatine or creatine monohydrate. Baseline and post-testing evaluations are conducted.

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of GI symptoms and fluid distribution.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Creatine Monohydrate
• OptiCreatine

Trial Overview The study is testing OptiCreatine against Creatine Monohydrate to see which one increases plasma creatine more effectively while minimizing gastrointestinal discomfort. It's a blind test where neither participants nor researchers know who gets which supplement during the trial.

How Is the Trial Designed?

Group I: OptiCreatine Experimental Treatment 1 Intervention

Combines creatine with other bioactive compounds purported to enhance absorption.

Group II: Creatine monohydrate Active Control 1 Intervention

Who Is Running the Clinical Trial?

TSI Group LTD

Lead Sponsor

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225335

Impact of OptiCreatine on Plasma Creatine and ... Primary outcomes include plasma creatine concentrations, gastrointestinal symptomatology, and fluid distribution measured through bioelectrical ...

2. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1424972/full

The effects of creatine supplementation on cognitive ... The meta-analysis results (Figure 3) indicate that creatine supplementation does not have a significant impact on overall cognitive function.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11275561/

The effects of creatine supplementation on cognitive function ... Current evidence suggests that creatine monohydrate supplementation may confer beneficial effects on cognitive function in adults.

4. medicaldevicenavigator.com medicaldevicenavigator.com/upcoming_clinical_trial_opticreatine_effects/

Upcoming Clinical Trial to Explore OptiCreatine's Impact on ... The upcoming clinical trial will examine the role of OptiCreatine, a dietary supplement, in enhancing plasma creatine levels in healthy adults.

5. researchforme.unc.edu researchforme.unc.edu/study-details?rcid=6789

Creatine Supplementation in Healthy Adults OptiCreatine combines creatine with other ingredients that may help the body absorb it more easily and reduce digestive issues. In this study, healthy men and ...

6. tsigroupltd.com tsigroupltd.com/opticreatine/

OptiCreatine OptiCreatine is an advanced creatine processing technology engineered to elevate solubility, clarity, and user experience.

7. targetmol.com targetmol.com/attachment/SDS/3B282ADC-C9EB-4404-8B45-D054BE082692/T22300

Safety Data Sheet ACCIDENTAL RELEASE MEASURES. 6.1. Personal precautions, protective equipment and emergency procedures. Avoid dust formation.

8. precision.fda.gov precision.fda.gov/ginas/app/ui/substances/241Y7MZO9U

GSRS

9. nutraceuticalbusinessreview.com nutraceuticalbusinessreview.com/tsi-s-myhmb-receives-regulatory-approval-from-korea-as

TSI's myHMB receives regulatory approval from Korea as a ... The Korea's Ministry of Food and Drug Safety (MFDS) required extensive safety and efficacy data as well as detailed information about TSI's ...