Research
Safety Profile & Toxicology
Cissuslean® safety has been evaluated through laboratory research and controlled human studies including normal-cell viability testing, clinical laboratory monitoring, adverse-event assessment and therapy-adherence data — supporting a favorable tolerability profile under the conditions studied.
Toxicology and preclinical safety
Normal-cell viability
An MTT assay using normal HFF-1 human fibroblast cells showed high viability across tested Cissuslean® concentrations. No visible morphological signs of cytotoxicity were reported under the experimental conditions.
Animal observations
In a high-fat-diet C57BL/6J mouse model, oral doses of 25, 50 and 100 mg/kg were assessed. Cissuslean® reduced diet-associated elevations in ALT and AST relative to the untreated HFD group, with dose-dependent mitigation of obesity-related liver and metabolic abnormalities.
A numerical acute oral LD50, 90-day NOAEL, Ames test, chromosomal-aberration test and reproductive-toxicity study were not provided in the reviewed materials and are not claimed on this page.
Human tolerability
Cissuslean® was evaluated in a 12-week, randomized, double-blind, placebo-controlled clinical trial in overweight or obese adults (PPS: 45 Cissuslean® vs 41 placebo). Safety monitoring included adverse events, hematology, clinical biochemistry, vital signs, therapy adherence and therapy-related discontinuations.
Mild adverse events were reported in both groups and were considered unrelated to the study supplement. No serious adverse events were reported and there were no clinically significant laboratory changes. Therapy adherence remained high with no therapy-related discontinuations.
A separate 84-day randomized, double-blind, placebo-controlled study evaluated Cissuslean® at 300 mg in adults with knee osteoarthritis, with safety monitored as a study objective.
Regulatory status by region
| United States | Intended use and regulatory classification must be assessed for the finished product. GRAS status was not documented. |
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| European Union | Suitability must be evaluated against applicable food-supplement, novel-food and contaminant requirements. |
| India | Use must comply with applicable FSSAI ingredient category, conditions of use and finished-product requirements. |
| Other markets | Regulatory acceptance should be confirmed for the proposed dose, application and claims. |
Disclaimer: This information summarizes research documents supplied for Cissuslean® and is intended for professional B2B use. It does not constitute medical advice or automatic regulatory authorization. Finished-product manufacturers are responsible for confirming legal status, permitted dosage, labelling and claims in each target market.