Abstract
BACKGROUND: Available evidence regarding effect of Cornus mas L. fruit extract (CMFE) as an anthocyanins source on glycemic control, insulin resistance, and adiponectin levels among metabolic dysfunction-associated steatotic liver disease (MASLD) patients is limited and controversial. Thus, this study aimed to assess effect of CMFE on glycemic control, insulin resistance, and adiponectin levels in MASLD patients. METHODS: This double-blind, randomized controlled clinical trial was carried out among 50 MASLD patients for 12 weeks. The participants were randomly categorized into the CMFE (CMFE, 20 cc/day; providing 32 mg/day total anthocyanin) or the placebo groups. Fasting plasma glucose and insulin levels, adiponectin, homeostatic model assessment of insulin resistance, triglyceride and glucose index, metabolic score for insulin resistance, quantitative insulin sensitivity check index, and visceral adiposity index were evaluated at baseline and after 12 weeks. Finally, a total number of 40 individuals completed the study (CMFE group: n = 18, placebo group: n = 22). RESULTS: Adiponectin levels significantly reduced after 12 weeks versus baseline in the placebo group among total population (ITT approach: baseline: 610.0 (430.0 to 710.0), after 12 weeks: 460.0 (390.0 to 580.0); P = 0.01) and among women (ITT approach: baseline: 675.0 (605.0 to 742.50), after 12 weeks: 435.0 (417.5 to 582.50), P = 0.01) without any significant difference in compared with the CMFE group. Moreover, a significant decreasing trend for changes of adiponectin levels was found in the placebo group versus the CMFE group only in women at the end of study (ITT approach: Placebo group: -220.0 (-290 to -37.50), CMFE group: -10.0 (-210.0 to 172.5); P = 0.01). However, CMFE consumption had no significant effect on glycemic control and insulin resistant indices (P > 0.05). CONCLUSIONS: CMFE consumption may have a beneficial impact on adiponectin levels especially in women. However, CMFE had no significant effect on glycemic control and insulin resistant indices. To clarify our vision, further studies with longer durations, larger sample sizes and different extract dosages are required. Moreover, mechanistic investigations should be conducted in this field. TRIAL REGISTRATION: Registered on 30/09/2018 at Iranian Registry of Clinical Trials under code IRCT20180419039359N1, with URL: https://www.irct.ir/trial/30707 .