Inflammatory markers response to crocin supplementation in patients with type 2 diabetes mellitus: A randomized controlled trial

Abstract

Inflammation and oxidative stress is a risk factor for the development of long-term consequences in patients with type 2 diabetes mellitus (T2DM). This study was designed to investigate the effects of crocin consumption on oxidative stress and inflammatory markers in patients with T2DM. In this clinical trial with a parallel-group design, 50 patients with T2DM were randomly assigned to either the crocin or the placebo group. The crocin group received 15 mg crocin twice daily, whereas the placebo group received corresponding placebos. At baseline and the end of week 12, serum high sensitive C-reactive protein (hs-CRP), interleukin-6 (IL-6), tumor necrosis factor-ɑ (TNF-ɑ), nuclear factor-κB (NF-κB), and malondialdehyde (MDA) were measured. Compared with placebo group, crocin reduced hs-CRP (−1.03 vs. 1.42, p = .007), TNF-ɑ (−0.8 vs. 0.28, p = .009), and NF-κB (−0.39 vs. 0.01, p = .047) after 12 weeks intervention; these improvements were also significant in comparison with the baseline values. Plasma IL-6 decreased significantly in the crocin group at the end of week 12 compared to baseline (p = .037), whereas no significant change was observed in the placebo group. Plasma concentration of MDA did not change within and between groups after intervention. This study indicates that daily administration of 30 mg crocin supplement to patients with T2DM reduces the concentrations of hs-CRP, TNF-ɑ, and NF-κB which are involved in the pathogenesis of complications of T2DM.

Effect of saffron supplementation on oxidative stress markers (MDA, TAC, TOS, GPx, SOD, and pro-oxidant/antioxidant balance): An updated systematic review and meta-analysis of randomized placebo-controlled trials

“…The dosage used for saffron intervention was between 30 and 1,000 mg/day, and that for crocin was between 15 and 30 mg/day. The selected trials included participants with coronary artery disease ( 44 ), type 2 diabetes ( 45 – 49 ), COPD ( 17 ), multiple sclerosis ( 50 ), ulcerative sclerosis ( 51 ), non-alcoholic fatty liver ( 52 ), overweight/obese prediabetic patients ( 20 , 53 , 54 ), rheumatoid arthritis ( 55 ), Alzheimer’s Disease ( 56 ), and methadone maintenance treatment patients ( 57 ).…”

Effect of crocin of Crocus sativus L. on serum inflammatory markers (IL-6 and TNF-α) in chronic obstructive pulmonary disease patients: a randomised, double-blind, placebo-controlled trial

“…Different clinical trials on inflammatory factors have reported different effects of saffron and crocin as active ingredients. Shahbazian et al found saffron and crocin to improve serum levels of CRP in healthy individuals and patients with diabetes (14,33,34) . The serum levels of CRP, however, were not significantly changed after the intervention according to Azimi (patients with diabetes) (35) , Mousavi (patients with schizophrenia) (36) , Kermani (metabolic syndrome subjects) (37) and Ebrahimi (diabetic patients) (38) .…”

A randomized clinical trial of beetroot juice consumption on inflammatory markers and oxidative stress in patients with type 2 diabetes

“…So, targeting inflammation pathways could potentially be a component of the new therapeutic strategies to prevent and control metabolic disorders, including T2DM (Wu & Ballantyne, 2020). Inflammation in patients with T2DM is caused by elevated levels of glucose, which can accelerate several mechanisms, including increased intracellular production of advanced glycation end products (AGEs), formation of mitochondrial reactive oxygen species, activation of nuclear factor κB (NF‐κB), and activation of protein kinase C (Behrouz et al., 2021; Mazzone et al., 2008). Beetroot is a rich source of phytochemical compounds that may provide health‐related benefits associated with antioxidant, anti‐inflammatory, and other physiological effects, particularly for disorders characterized by chronic inflammation (Clifford et al., 2015).…”

“…To estimate the sample size, we used the standard formula suggested for randomized clinical trials based on the power (1‐β) of 80% and type one error (α) of 0.05. According to a previous study (Behrouz et al., 2021) and considering the TNF‐α as a key variable with a pooled standard deviation of 0.6 pg/ml, the current study needed 22 patients in each group to have 80% study power. Assuming a 20% potential loss of samples in each group, we calculated to have 26 participants per group.…”