Safety evaluation of an effervescent curcuminoids-ascorbic acid-polysaccharide-β-cyclodextrin (CUR-A-Poly-β-CD) inclusion complex powder in healthy volunteers: A non-placebo-controlled pilot study.

Colorectal cancer (CRC) is a prevalent and aggressive malignancy with a high mortality rate. Although chemotherapy can improve survival outcomes, it is frequently associated with undesirable side effects. Curcuminoids, the principal polyphenol derived from Curcuma longa L., have demonstrated promising potential as an alternative anticancer agent. Previous studies have shown that the effervescent curcuminoid-ascorbic acid-polysaccharide-β-cyclodextrin (CUR-A-Poly-β-CD) inclusion complex exerts anticancer effects against colorectal cancer cells, with no acute toxicity observed in animal models. In this study, the safety of the CUR-A-Poly-β-CD effervescent powder (equivalent to 500 mg of curcuminoids) was evaluated in healthy volunteers. Of the 20 individuals screened, 16 participants completed the 90-day intervention. Clinical assessments indicated stable hematological, biochemical, and electrolyte parameters throughout the study period. No signs of allergic reactions to the CUR-A-Poly-β-CD effervescent powder were observed. The adverse drug reactions (ADRs) observed in this study included somnolence and mild gastrointestinal symptoms such as transient diarrhea (18.75%) and nausea (6.25%); all were self-limiting and required no medical intervention. This non-placebo-controlled pilot study provides preliminary evidence supporting the safety of the CUR-A-Poly-β-CD effervescent powder for consumption and its considerable potential as a therapeutic agent or dietary supplement for patients with colorectal cancer.