Creatine Pure+: Ingredient Evidence Dossier

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§1 Key points

• What it is: an unflavored creatine monohydrate powder, one ingredient, 5 g (5,000 mg) per 1-scoop serving, 50 servings per container. → §3
• This product itself has not been tested in a clinical trial: the research described here was conducted on creatine (creatine monohydrate), sometimes at different amounts or in different forms. → §4
• Where the human evidence is strongest and weakest: the human research is strongest for muscle strength and high-intensity exercise performance (high certainty at the ingredient level), moderate for gains in lean body mass alongside resistance training, and lower and more mixed for cognition. → §2
• Dose honesty: our 5 g per day is the standard maintenance amount used across the human studies — this is one of the few ingredients where our amount matches the studied amount directly. An optional "loading" phase (about 20 g/day for 5–7 days) is described in the literature but is not required. → §2
• Safety headline: creatine is one of the most-studied supplements and has been well tolerated in healthy adults; talk to a healthcare professional first if you are pregnant or nursing, under 18, have a kidney condition, or take prescription medication. → §6
• Testing: the current lot (R604400) was third-party tested for identity/potency, heavy metals and microbial safety, and passed; lot results are available by lot number on request. → §7

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

§2 At a glance

Caption: "Certainty describes how confident we are in the published human research on the ingredient, not the tested effect of this product. See Methods and the certainty scale (Appendix A of this document)."

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

§3 Formula and label facts

Transcribed from the Supplement Facts panel (label artwork on file). Values marked TBD await confirmation of the physical label revision (see Open Items).

• Serving size: 1 scoop (5.6 g) · Servings per container: 50 · Net weight: ~250 g · Directions (as on label): "TBD — transcribe verbatim from label" (typical use: mix 1 scoop in 8–12 oz of water or juice once daily).
• Because the directions are one serving per day, per-serving and per-day amounts are the same.
• Scoop-vs-servings note: the scoop is 5.6 g and the supplier panel states 50 servings; 250 g net ÷ 5.6 g ≈ 44.6 scoops. This is a supplier-label inconsistency carried on the panel; the dossier reports the panel figure (50 servings) and flags the arithmetic (see Open Items).
• Scoop-mass note: a 5.6 g scoop delivers 5,000 mg of creatine monohydrate, leaving ~0.6 g (~11%) of scoop mass unaccounted for on a single-ingredient label — most likely scoop-fill tolerance or moisture rather than an undeclared ingredient. To be reconciled with the supplier (see Open Items).

Supplement Facts (text version of the panel), per 1-scoop (5.6 g) serving:

† Daily Value not established.

• Other ingredients (as labeled): none declared — single-ingredient, unflavored powder (confirm from physical label).
• Allergen and label statements (as labeled): none declared (confirm from physical label).
• Label warnings (verbatim): "TBD — transcribe from label."
• Sourcing note: manufactured in a cGMP facility in the USA. No branded/trademarked creatine grade is claimed, and no raw-material country-of-origin claim is made (see §8).
• Ingredient regulatory status (short): creatine monohydrate is marketed as a dietary ingredient; specific regulatory status is recorded in the internal evidence file and nothing is asserted here beyond what is documented.

§4 Evidence by ingredient

This product itself has not been tested in a clinical trial. The research described here was conducted on creatine (creatine monohydrate), sometimes at different amounts or in different forms.

How to read this section: The section below lists human studies in generally healthy adults, the amount and form studied, what was measured, and who paid for the study where declared. The certainty rating describes the research on the ingredient, not a tested effect of this product.

4.1 Creatine monohydrate (5,000 mg per serving)

How to read this: the questions below are the ones customers and AI assistants ask most — "What does the research show?", "Is the amount here the same as in the studies?", "What is not known?".

• Short answer: High certainty that creatine monohydrate supports muscle strength and high-intensity exercise performance in generally healthy adults, at the 5 g/day amount used here; Moderate certainty that it supports gains in lean body mass alongside resistance training; the cognition evidence is Low and mixed. Creatine's role in the cellular energy (ATP) system is a well-established mechanism.
• What it is: Creatine is a compound the body makes from amino acids and also gets from meat and fish. In muscle it is stored as phosphocreatine, which rapidly regenerates ATP — the cell's short-term energy currency — during brief, intense effort. Supplementing raises muscle creatine and phosphocreatine stores [1][2].

A. Muscle stores and dosing (pharmacokinetics)

B. Strength, power and high-intensity performance

C. Lean body mass (with resistance training)

D. Cognition (healthy adults)

• Certainty: High for muscle strength and high-intensity performance — several RCTs summarized in systematic reviews and meta-analyses [4][5][6] and a narrative review [7] (not itself a primary trial), plus a society position stand [3], all consistent, within the studied dose range and in the studied form (creatine monohydrate). Moderate for lean body mass with resistance training [4][8]. Established mechanism for the cellular-energy (ATP/phosphocreatine) role [1][2]. Low for cognition — few, small, mixed human trials, with clearer signals only under stressors such as sleep deprivation [11].
• Our amount vs studied amounts: studied 3–5 g/day maintenance (optional ~20 g/day loading for 5–7 days); ours 5 g per serving → Within range (5 g is the standard studied maintenance dose). Form: Same (creatine monohydrate — the form used in the large majority of the human research).
• Mixed or null findings: cognitive outcomes are inconsistent across studies [10]; creatine's performance benefit is specific to short, high-intensity efforts, not endurance [3][4]. Response varies between people, and those who already eat a lot of meat/fish may respond less [3].
• What is not known: the size of any cognitive effect at a 5 g/day maintenance dose in healthy adults, and long-term outcomes beyond the durations studied.

§5 How the ingredient works

This section explains why creatine is offered as a single ingredient at 5 g. It describes a formulation rationale, not a demonstrated effect of this product.

Creatine Pure+ is a single-ingredient product: creatine monohydrate at 5 g, the amount and form most used in the human research [3][14]. There is no blend and no proprietary mixture — the rationale is simply to deliver the studied ingredient at the studied maintenance dose, in the studied form, without additives. Creatine is studied for its role in the phosphocreatine system, which regenerates ATP during brief, intense effort [1][2].

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

§6 Safety

Summary: creatine monohydrate is one of the most extensively studied dietary supplements and has been well tolerated in healthy adults in both short- and long-term studies; the practical points below are the common, minor effects and the situations where a clinician should be consulted first.

Per-ingredient safety table:

• Long-term data: long-term creatine supplementation did not significantly affect clinical markers of health in the studied populations [12], and reviews of common concerns (kidney function, hydration, cramping, hair loss) have not found support for them in healthy people [13].
• Talk to a healthcare professional before use if you: are pregnant or nursing; are under 18; have a kidney condition or take medications that affect the kidneys; take prescription medication; or have a scheduled surgery.
• Allergens: none declared (confirm from label). Label warnings: TBD — transcribe verbatim from the label.
• Hydration: because creatine draws water into muscle, drink adequate fluids.
• Report a problem: contact Stellar Health Labs (hello@stellarhealthlabs.com); adverse events can also be reported to FDA MedWatch (https://www.fda.gov/safety/medwatch).

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

§7 Quality and lab testing

The label specification and the lot result are shown as separate columns. A missing value renders as "not tested on this lot", never as an inferred default.

• Lot: R604400 · Tested: May 2026 (identity/assay 2026-05-08; microbial 2026-05-11; heavy metals 2026-05-12)
• Laboratory: an independent third-party laboratory. The heavy-metals screen used an ISO/IEC 17025-accredited ICP-MS/MS method (separate report, lot 500100525629A). The laboratory and the ingredient supplier are not named because the certificate identifies the supplier; the accreditation body and certificate number are pending on file (see Open Items).
• Availability: Current lot R604400 — lab results on request. The COA PDF is not hosted publicly because it identifies the supplier; lot results are provided by lot number on request (`/pages/request-coa`).

Testing — lot R604400:

• Not tested on this lot: the creatine-specific impurity panel (creatinine, dicyandiamide, dihydrotriazine) was not measured on lot R604400. These impurities were measured within limits on a prior production lot, but a certificate reports only the results for the lot and tests listed, so no impurity value is claimed for R604400 here. A certificate of analysis reports results for the lot and tests listed. It does not show how the product will affect any individual.
• Testing program: each production lot is third-party tested for identity, contaminants, heavy metals and microbial safety; lot-specific results are made available by lot number on request.

§8 Manufacturing

• Made by: manufactured in a cGMP facility in the USA from globally sourced ingredients, operating under FDA's dietary-supplement current Good Manufacturing Practice rule (21 CFR Part 111). The manufacturer's name is held confidential.
• Facility certifications (issuer · standard · certificate # · expiry): cGMP; specific facility certificate documentation is pending on file.
• Key raw material: creatine monohydrate. No branded/trademarked creatine grade, and no raw-material country-of-origin claim, is made.
• Packaged in / country of manufacture: USA.
• (This is a dietary supplement; it is not approved or registered as a drug by the FDA, and no such status — nor any country-of-origin claim beyond USA manufacture — is claimed.)

§9 Limitations of this dossier

This product itself has not been tested in a clinical trial. The research described here was conducted on creatine (creatine monohydrate), sometimes at different amounts or in different forms.

• Population and outcome fit: most creatine research is in exercising or athletic adults; the strongest outcomes are for short, high-intensity performance and, with resistance training, lean mass. Endurance and cognition are weaker or mixed.
• Individual variation: people who already have high muscle creatine (for example, regular meat/fish eaters) may respond less; some individuals are "non-responders" [3].
• Cognition evidence is Low and mixed [10][11]; no cognitive claim is made beyond "studied for a role in cognition".
• Label transcription pending: directions, other ingredients, warnings, SKU/GTIN and the label revision are pending physical-label artwork; the scoop-vs-servings arithmetic (250 g ÷ 5.6 g ≈ 44.6 vs a stated 50 servings) needs supplier reconciliation.
• Testing scope: the current lot has identity/assay, heavy metals and microbial results, but not the creatine-specific impurity panel; the COA is not published publicly (it names the supplier).
• Funding transparency: many of the primary creatine reports did not state their funding, and several reviews are authored by sports-nutrition researchers with known industry ties. This is noted for transparency; the ratings rest on the consistency of multiple independent trials and meta-analyses, not on any single funded study. Full-text funding statements will be recorded in the internal evidence file before publication.
• Scope: this dossier covers research relevant to normal structure and function in generally healthy adults only.

§10 Methods: how this dossier was prepared

• Search: PubMed/MEDLINE, the Cochrane Library, ClinicalTrials.gov, NIH ODS and the ISSN literature were searched on 2026-09-23 (search strings and counts are kept on file in the internal evidence file). Screening moved from records identified → screened → included, with disease-population and disease-titled records routed to the internal file.
• Inclusion: human studies of creatine (creatine monohydrate) in generally healthy adults, reporting outcomes related to normal structure or function; systematic reviews and meta-analyses first. Laboratory and animal research is labeled as such.
• Verification: every reference was checked against PubMed for existence, bibliographic accuracy, retraction status and disease-title flag using `verify_pmids.py`; every cited PMID returned status OK-MACHINE on 2026-09-23, and each was read for relevance to the ingredient and statement it supports.
• AI-assistance line: Parts of this dossier were drafted with AI assistance. Every reference was verified against PubMed and read by the preparer before publication.
• Certainty ratings: an adaptation of the GRADE approach (Appendix A). There is no overall product score.
• Conflicts of interest: Stellar Health Labs makes and sells this product. Reviewer compensation, if a reviewer is named in a later version, is disclosed with the byline.
• Corrections: errors are corrected promptly and recorded in the version history (§13). Report an error: hello@stellarhealthlabs.com.

§11 Common questions

• How much creatine is in one serving, and how do I take it? Each 1-scoop (5.6 g) serving provides 5,000 mg (5 g) of creatine monohydrate; there are 50 servings per container. Mix one scoop in water or juice once a day. → §3
• Has Creatine Pure+ itself been clinically tested? No. The finished product has not been tested in a clinical trial; the research here is on creatine (creatine monohydrate). → §4
• Is 5 g the amount used in studies? Yes — 3–5 g per day is the standard maintenance amount across the human research, so our 5 g is within the studied range. A loading phase (about 20 g/day for 5–7 days) is optional. → §2
• Do I need to "load"? No. Loading fills muscle stores faster, but a steady 5 g/day reaches the same level over a few weeks [2]. → §4
• What was this lot tested for? Lot R604400 was third-party tested for identity/potency (assayed at 100.44%), heavy metals (none detected) and microbial safety (pass). Results are available by lot number on request. → §7
• Is it safe for my kidneys? Creatine has been well tolerated in healthy people, and long-term studies have not shown harm to clinical health markers [12][13]. If you have a kidney condition or take medications that affect the kidneys, check with a clinician first. → §6
• Who should not take it? Talk to a healthcare professional first if you are pregnant or nursing, under 18, have a kidney condition, take prescription medication, or have surgery scheduled. → §6

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

§12 References

Numbered in order of first citation. Every entry links to PubMed and to the DOI where available. Only citations that passed the public-citation filter appear here.

1. Harris RC, Söderlund K, Hultman E. Elevation of creatine in resting and exercised muscle of normal subjects by creatine supplementation. Clin Sci (Lond). 1992;83(3):367–374. doi:10.1042/cs0830367 PMID: 1327657. — Used in: §4.1.
2. Hultman E, Söderlund K, Timmons JA, et al. Muscle creatine loading in men. J Appl Physiol (1985). 1996;81(1):232–237. doi:10.1152/jappl.1996.81.1.232 PMID: 8828669. — Used in: §4.1.
3. Kreider RB, Kalman DS, Antonio J, et al. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine. J Int Soc Sports Nutr. 2017;14:18. doi:10.1186/s12970-017-0173-z PMID: 28615996. — Used in: §4.1, §6.
4. Branch JD. Effect of creatine supplementation on body composition and performance: a meta-analysis. Int J Sport Nutr Exerc Metab. 2003;13(2):198–226. doi:10.1123/ijsnem.13.2.198 PMID: 12945830. — Used in: §4.1.
5. Lanhers C, Pereira B, Naughton G, et al. Creatine supplementation and lower limb strength performance: a systematic review and meta-analyses. Sports Med. 2015;45(9):1285–1294. doi:10.1007/s40279-015-0337-4 PMID: 25946994. — Used in: §4.1.
6. Lanhers C, Pereira B, Naughton G, et al. Creatine supplementation and upper limb strength performance: a systematic review and meta-analysis. Sports Med. 2017;47(1):163–173. doi:10.1007/s40279-016-0571-4 PMID: 27328852. — Used in: §4.1.
7. Rawson ES, Volek JS. Effects of creatine supplementation and resistance training on muscle strength and weightlifting performance. J Strength Cond Res. 2003;17(4):822–831. doi:10.1519/1533-4287(2003)017<0822:eocsar>2.0.co;2 PMID: 14636102. — Used in: §4.1.
8. Chilibeck PD, Kaviani M, Candow DG, Zello GA. Effect of creatine supplementation during resistance training on lean tissue mass and muscular strength in older adults: a meta-analysis. Open Access J Sports Med. 2017;8:213–226. doi:10.2147/OAJSM.S123529 PMID: 29138605. — Used in: §4.1.
9. Cooke MB, Rybalka E, Williams AD, et al. Creatine supplementation enhances muscle force recovery after eccentrically-induced muscle damage in healthy individuals. J Int Soc Sports Nutr. 2009;6:13. doi:10.1186/1550-2783-6-13 PMID: 19490606. — Used in: §4.1.
10. Avgerinos KI, Spyrou N, Bougioukas KI, Kapogiannis D. Effects of creatine supplementation on cognitive function of healthy individuals: a systematic review of randomized controlled trials. Exp Gerontol. 2018;108:166–173. doi:10.1016/j.exger.2018.04.013 PMID: 29704637. — Used in: §4.1.
11. Forbes SC, Cordingley DM, Cornish SM, et al. Effects of creatine supplementation on brain function and health. Nutrients. 2022;14(5):921. doi:10.3390/nu14050921 PMID: 35267907. — Used in: §4.1.
12. Kreider RB, Melton C, Rasmussen CJ, et al. Long-term creatine supplementation does not significantly affect clinical markers of health in athletes. Mol Cell Biochem. 2003;244(1–2):95–104. PMID: 12701816. — Used in: §6.
13. Antonio J, Candow DG, Forbes SC, et al. Common questions and misconceptions about creatine supplementation: what does the scientific evidence really show? J Int Soc Sports Nutr. 2021;18(1):13. doi:10.1186/s12970-021-00412-w PMID: 33557850. — Used in: §6.
14. Wax B, Kerksick CM, Jagim AR, et al. Creatine for exercise and sports performance, with recovery considerations for healthy populations. Nutrients. 2021;13(6):1915. doi:10.3390/nu13061915 PMID: 34199588. — Used in: §5.

§13 Review, authorship and disclosures

• Prepared by: Stellar Health Labs. Parts of this dossier were drafted with AI assistance; every reference was verified against PubMed and read by the preparer before publication.
• Independent scientific review of this version: pending.
• Disclosure: This dossier is published by Stellar Health Labs, the company that makes and sells Creatine Pure+.
• Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
• Not medical advice: This document is for information only and is not a substitute for advice from a healthcare professional.
• Copyright: © 2026 Stellar Health Labs. All rights reserved. Brief quotation with attribution and a link to this page is permitted.
• How to cite: Stellar Health Labs. Creatine Pure+: Ingredient Evidence Dossier. Dossier SHL-ED-CRE, version 1.0.0. 2026-09-23. https://stellarhealthlabs.com/pages/evidence/creatine-monohydrate

Version history

Superseded versions: none.

Appendix A — Certainty scale (GRADE-adapted; published with every dossier)

Rated per ingredient, per outcome, for human evidence in generally healthy adults. There is no product-level composite score and there are no letter grades.

Basis: the GRADE Working Group approach (Guyatt et al., BMJ 2008; GRADE Handbook). The adaptation is described openly as ours, not as an official GRADE assessment.