Oral supplementation with crocin (a constituent of saffron) in subjects with cigarette smoking: a clinical trial.

Smoking is one of the main causes of death in the world. Cigarette use is related with various components of metabolic syndrome (e.g., insulin resistance, raised blood pressure, dyslipidemia, oxidative stress, inflammation state) and psychiatric disorders. This study was conducted to determine the effect of crocin (Cro) supplementation on nicotine dependence, anxiety, depression, and metabolic indices in smokers. A total of 50 smokers were selected and randomly categorized into two groups (crocin and placebo). The intervention group received crocin (30 mg per day; n = 25) and placebo (containing Avicel; n = 25) once a day. The primary (nicotine dependence, depression, and anxiety inventory) and secondary (metabolic indices) outcomes were assessed at the start of the intervention and after the 3 months. Multiple linear regression models were used to assess the treatment effects on the outcomes adjusting for confounding variables. The primary outcome results such as nicotine dependence, depression, and anxiety inventory did not have a significant difference among the intervention groups (P > 0.05). Also in the secondary outcomes, fasting plasma glucose (FPG), insulin, and homeostasis model of assessment-insulin resistance (HOMA-IR) levels did indicate a significant difference by Cro intervention (β - 3.27 mg/dL; 95% CI, - 5.23, - 1.31; P = 0.002; β - 0.76 μIU/mL; 95% CI, - 1.38, - 0.15; P = 0.01; β - 0.18; 95% CI, - 0.29, - 0.07; P = 0.002), respectively. There were also significant reductions in serum levels of high-sensitivity C-reactive protein (hs-CRP) (β - 0.72 mg/L; 95% CI, - 1.37, - 0.07; P = 0.03), compared with the placebo. Cro intake may have favorable effects on the level of FPG, insulin, HOMA-IR, and hs-CRP in smokers. However, due to the small sample size and limited scientific reports on smokers, further studies are necessary. ClinicalTrial.gov Identifier: IRCT20170420033551N11.