Tier 3 — preclinical

Safety of Hyaluronan 35 in Healthy Human Subjects: A Pilot Study

Annette Bellar, Sean P Kessler, Dana R Obery, Naseer Sangwan, Nicole Welch, Laura E Nagy, Srinivasan Dasarathy, Carol de la Motte
Nutrients 2019 11(5):1135

Bibliography

PubMed
PMID 31121841
PubMed Central
PMC6566413
Trial registry
View on ClinicalTrials.gov Registered trial — results not yet published in a peer-reviewed journal.
Funding
Major support from NIH P01 HL107417-S1 with additional NIH grants and a Mikati Foundation grant.
Competing interests
The paper reports that funders had no role in study design, data collection, analysis, interpretation, writing or publication decisions.

Study snapshot

DesignProspective open-label human safety and tolerability pilot
ModelHealthy adults
Samplen=20
InterventionPharmaceutical-grade 35 kDa sodium hyaluronate 140 mg/day orally
Duration7 days dosing; follow-up to day 28
EndpointsAdverse events; Clinical chemistry; Metabolic function; Gut permeability; Stool microbiome composition

What the study showed, in plain terms

Twenty healthy adults took 140 mg/day of 35 kDa sodium hyaluronate for seven days. The product was well tolerated with no serious adverse events and no major adverse laboratory, metabolic or microbiome signal through follow-up. This is useful direct human safety evidence, but it is too small and short to establish long-term supplement safety.

Key findings

What this study can and cannot tell us

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