# Comparative Efficacy and Pharmacokinetic Parameters of Micronized Creatine Monohydrate (KleanCREATINE™) in Active Men: A Randomized, Controlled Clinical Study

**Authors:** Pravin Aggarwal, Ramshyam Agarwal

PMC · DOI: 10.7759/cureus.103091 · Cureus · 2026-02-06

## TL;DR

A clinical study found that micronized creatine monohydrate (KleanCREATINE™) improves muscle strength, endurance, and body composition more effectively than standard creatine in active men.

## Contribution

Demonstrates superior pharmacokinetics and efficacy of micronized creatine monohydrate compared to conventional formulations in active individuals.

## Key findings

- KleanCREATINE™ showed higher bioavailability and faster absorption compared to standard creatine.
- It significantly reduced body fat and increased muscle mass over eight weeks.
- Users reported lower perceived exertion and improved chest press endurance.

## Abstract

Introduction

This two-phase clinical study evaluated KleanCREATINE™ (micronized creatine monohydrate) for its pharmacokinetic properties, safety, and efficacy in active men.

Materials and methods

Phase I was a randomized, open-label, crossover study comparing its pharmacokinetic profile with a marketed creatine monohydrate in 10 healthy men. Phase II was a randomized, double-blind, parallel-arm trial in 52 active men over eight weeks, assessing the safety and efficacy of KleanCREATINE™ on muscle strength, endurance, hypertrophy, body composition, and perceived exertion.

Results

In Phase I, KleanCREATINE™ demonstrated better pharmacokinetics profile with higher Cmax (8.10 vs 4.80 nmol/UI), quicker Tmax (2 vs 3 hours), and greater relative bioavailability (160.42% in sequence one and 175.45% in sequence two) over the marketed formulation. Phase II revealed significant effectiveness of KleanCREATINE™ over eight weeks: significant reduction in body fat percentage (14.45%), increase in skeletal muscle (10.46%), and enhanced muscle hypertrophy. KleanCREATINE™ showed greater chest press endurance (60.05% vs 49.29%). Perceived exertion decreased more with KleanCREATINE™ (26.4% vs 13.46%). Both formulations demonstrated safety and tolerability, with no adverse effects reported.

Conclusions

Micronized KleanCREATINE™ exhibited faster absorption, higher bioavailability, and greater efficacy in improving strength, endurance, and body composition compared to standard creatine monohydrate, with an excellent safety profile. These findings suggest KleanCREATINE™ as a promising alternative for athletes and fitness enthusiasts.

## Linked entities

- **Chemicals:** creatine monohydrate (PubChem CID 80116)

## Full-text entities

- **Genes:** MYH14 (myosin heavy chain 14) [NCBI Gene 79784] {aka DFNA4, DFNA4A, FP17425, MHC16, MYH17, NMHC II-C}
- **Diseases:** Muscle Hypertrophy (MESH:C536106), muscle (MESH:D019042), renal or liver dysfunction (MESH:D008107), neurodegenerative diseases (MESH:D019636), bone loss (MESH:D001847), cardiovascular disease (MESH:D002318), fibromyalgia (MESH:D005356), cancer (MESH:D009369), hypertrophy (MESH:D006984), Fatigue (MESH:D005221)
- **Chemicals:** phosphate (MESH:D010710), caffeine (MESH:D002110), CP (-), ADP (MESH:D000244), triglycerides (MESH:D014280), CrM. (MESH:D003401), PCr (MESH:D010725), lactate (MESH:D019344), amino acid (MESH:D000596), lipid (MESH:D008055), water (MESH:D014867), ATP (MESH:D000255), cholesterol (MESH:D002784), creatinine (MESH:D003404), calcium (MESH:D002118), alcohol (MESH:D000438)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

8 figures with captions in the complete paper: https://tomesphere.com/paper/PMC12968080/full.md

## References

19 references — full list in the complete paper: https://tomesphere.com/paper/PMC12968080/full.md

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Source: https://tomesphere.com/paper/PMC12968080