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Technical Analysis Details
Key Findings
This systematic review concluded that oral L-ornithine (L-Orn) hydrochloride is safe for healthy adults at doses up to 12,000 mg/day, identified as the no observed adverse effect level (NOAEL). Gastrointestinal disorders were the primary adverse events (AEs), but integrated analysis showed no statistically significant increase in risk with supplementation versus control (risk difference: 0.00; 95% CI: ±0.02; P = 1.00). No severe AEs were reported across all included studies.
Study Design
The study was a systematic review (PROSPERO: UMIN000033371) analyzing clinical trials of oral L-Orn in healthy subjects. Databases searched included PubMed, Cochrane Library, Ichushi-Web, and EBSCOhost. Of 22 eligible articles identified, all involved healthy human participants. The review synthesized data from these trials but did not conduct new primary research. Participant demographics (e.g., age, sex) were not aggregated in the summary.
Dosage & Administration
L-Orn was administered orally as L-Orn hydrochloride. Doses ranged up to 14,025 mg/person/day, with administration durations spanning single doses to 156 days (maximum). The review focused exclusively on oral intake in healthy individuals, excluding intravenous or diseased populations.
Results & Efficacy
No efficacy outcomes were assessed, as this was a safety-focused review. Key safety results:
- Maximum tested dose: 14,025 mg/day (hydrochloride form).
- Primary AEs: Mild gastrointestinal disorders (e.g., diarrhea, nausea).
- NOAEL: 12,000 mg/person/day for L-Orn hydrochloride.
- Risk difference for GI disorders: 0.00 (95% CI: −0.02 to +0.02; P = 1.00), indicating no significant association between L-Orn intake and GI events.
Limitations
The review’s limitations include:
1. Heterogeneity: Varied study designs, doses, and durations across the 22 included trials.
2. Short-term focus: Maximum duration was 156 days; long-term safety (>6 months) remains unassessed.
3. Population specificity: Only healthy subjects were analyzed; safety in clinical populations (e.g., liver disease) is unknown.
4. Publication bias: Potential underreporting of minor AEs in primary studies.
Future research should address long-term use and diverse populations.
Clinical Relevance
For supplement users, this review supports the short-term safety of oral L-Orn hydrochloride at doses ≤12 g/day in healthy adults, with minimal GI risk. However, it does not validate efficacy claims (e.g., for muscle recovery or sleep). Users should:
- Avoid exceeding 12 g/day based on current safety data.
- Consult healthcare providers before use if managing health conditions.
- Recognize that safety in non-healthy populations is unstudied. This evidence applies only to acute/short-term use in healthy individuals.
Original Study Reference
Safety assessment of L-ornithine oral intake in healthy subjects: a systematic review.
Source: PubMed
Published: 2025-05-05
📄 Read Full Study (PMID: 40323503)
