Impact of OptiCreatine on Plasma Creatine and Gastrointestinal Effects in Males and Females

NCT07225335 | Completed

• 1 other identifier: 25-2972
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the novel OptiCreatine formulation, which combines creatine with other bioactive compounds purported to enhance absorption and reduce gastrointestinal (GI) discomfort. Using a randomized, double-blind, crossover design, the study will compare the acute and chronic effects of OptiCreatine versus Creatine monohydrate in healthy, recreationally active adults. Participants will be asked to orally consume both the OptiCreatine and the creatine monohydrate. Primary outcomes include plasma creatine concentrations, gastrointestinal symptomatology, and fluid distribution measured through bioelectrical impedance spectroscopy.

Conditions

Creatine Absorption in Healthy Adults

Keywords

Absorption; creatine; Healthy adults

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic Outcomes: Concentration maximum (Cmax)

  the maximum observed plasma concentration (Cmax)

  Over a period of 5 hrs. post dose of creatine

• Pharmacokinetic Outcomes: Time to concentration maximum (Tmax)

  The time to reach the maximum observed plasma concentration

  Over a period of 5 hrs. post dose of creatine

• Pharmacokinetic Outcomes: Area Under the Curve (AUC)

  The area under the concentration-time curve (AUC)

  Over a period of 5 hrs. post dose of creatine

Secondary Outcomes (3)

• Digestion-associated Quality of Life Questionnaire (DQLQ) assessment

  6 days

• Self-perception questionnaire for assessment of bloating

  6 days

• Gastrointestinal Symptom Rating Scale (GSRS)

  6 days

Other Outcomes (5)

• Fluid distribution, Total Body water

  Baseline and after 6 days

• Height

  Baseline at day 6

• Weight

  Baseline and Day 6

Study Arms (2)

OptiCreatine

EXPERIMENTAL

Combines creatine with other bioactive compounds purported to enhance absorption.

Dietary Supplement: OptiCreatine

Creatine monohydrate

ACTIVE COMPARATOR

Dietary Supplement: Creatine Monohydrate

Interventions

OptiCreatine DIETARY_SUPPLEMENT

OptiCreatine is a formulation, which combines creatine with other bioactive compounds purported to enhance absorption.

OptiCreatine

Creatine Monohydrate DIETARY_SUPPLEMENT

Creatine monohydrate (Creapure®)

Creatine monohydrate

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between the ages of 18-45 yrs
• Body mass index of \<35 kg/m2
• Recreationally active \[≥30 minutes of moderate-intensity physical activity per week as defined by the International Physical Activity Questionnaire (IPAQ)\]
• Participant is healthy and free from disease as determined by a health history questionnaire.
• Participant agrees to abstain from caffeine (24 hrs. prior), tobacco (24 hrs. prior), and alcohol (24 hrs. prior) before testing days

You may not qualify if:

• Has chronic kidney disease, liver disease, chronic obstructive pulmonary disease, or cancer
• Currently using medications that may directly impact the primary outcomes including: diuretics and corticosteroids)
• Currently using creatine monohydrate
• Has severely impaired hearing or speech or inability to speak English

Sponsors & Collaborators

• TSI Group LTD: lead
• University of North Carolina: collaborator

Study Sites (1)

Applied Physiology Laboratory (Fetzer Hall, Room 025)

Chapel Hill, North Carolina, 27599-8700, United States

Location

MeSH Terms

Interventions

Creatine

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• John A Rathmacher, Ph.D.

  TSI Group LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Acute: In a randomized double-blind, cross-over design, participants will be randomly assigned using a using a computer-generated randomization scheme to consume either OptiCreatine or creatine monohydrate supplement. All participants will complete both treatments, including a minimum of a 3-day washout period. Chronic: In a randomized double-blind design, participants will be randomly assigned using block randomization in a 1:1 fashion to participants in a creatine loading dose of OptiCreatine or creatine monohydrate.

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 6, 2025
• Study Start: November 5, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)