Efficacy of nanocurcumin supplementation on insulin resistance, lipids, inflammatory factors and nesfatin among obese patients with non-alcoholic fatty liver disease (NAFLD): a trial protocol

Abstract

ObjectivesDifferent studies have been conducted on the role of curcumin in health since having multiple properties, including antioxidant and anti-inflammatory effects. Due to the lack of studies regarding curcumin effects on obese patients with non-alcoholic fatty liver disease (NAFLD), our protocol was designed to assess nanocurcumin impacts on blood sugar, lipids, inflammatory indices, insulin resistance and liver function, especially by nesfatin.SettingThis trial will be conducted in the Oil Company central hospital of Tehran, Iran with a primary level of care.Participants84 obese patients with NAFLD diagnosed using ultrasonography will be employed according to the eligibility criteria‎.InterventionsThe patients will be randomly divided into two equal groups (nanocurcumin and placebo, two 40 mg capsules per day with meals for 3 months, follow-up monthly). Also, lifestyle changes (low-calorie diet and physical activity) will be advised.Measures of the primary and secondary outcomesA general questionnaire, 24 hours food recall (at the beginning, middle and end) and short-form International Physical Activity Questionnaire will be completed. Blood pressure, anthropometrics, serum sugar indices (fasting blood sugar and insulin, insulin resistance and sensitivity and glycosylated haemoglobin), lipids (triglyceride, total cholesterol and low-density and high-density lipoprotein-cholesterol, inflammatory profiles (interleukin-6, high-sensitivity C-reactive protein, and tumour necrosis factor-alpha), liver function (alanine and aspartate transaminase) and nesfatin will be measured at the beginning and end of the study.ConclusionThis trial would be the first experiment to determine nanocurcumin efficacy on certain blood factors among obese patients with NAFLD. Nevertheless, studying the potential consequences of curcumin in various diseases, especially NAFLD, is required for clinical use.Trial registration numberIRCT2016071915536N3; pre-results.

Does turmeric/curcumin supplementation improve serum alanine aminotransferase and aspartate aminotransferase levels in patients with nonalcoholic fatty liver disease? A systematic review and meta‐analysis of randomized controlled trials

“…Among the initial 13,900 publications that were obtained by electronic search (5,535 duplicates), 8,355 were excluded because they were unrelated to present meta‐analysis according to our inclusion criteria. After reading the full text of the remaining 10 studies, four studies were also excluded for the following reasons: two studies did not report data on liver enzymes (Basu et al, ; Jazayeri‐Tehrani et al, ), one study was a duplicate report (Ghaffari, Rafraf, Navekar, & Asghari‐Jafarabadi, ), and one study was published as protocol (Jazayeri‐Tehrani et al, ). Finally, six eligible RCTs (Chirapongsathorn et al, ; Jarahzadeh & Hosain, ; Moradi et al, ; Navekar et al, ; Panahi et al, ; Rahmani et al, ) were included in our analysis.…”

“…After reading the full text of the remaining 10 studies, four studies were also excluded for the following reasons: two studies did not report data on liver enzymes (Basu et al, 2013;Jazayeri-Tehrani et al, 2018), one study was a duplicate report (Ghaffari, Rafraf, Navekar, & Asghari-Jafarabadi, 2018), and one study was published as protocol (Jazayeri-Tehrani et al, 2017). Finally, six eligible RCTs (Chirapongsathorn et al, 2012;Jarahzadeh & Hosain, 2017;Moradi et al, 2016;Navekar et al, 2017;Panahi et al, 2017;Rahmani et al, 2016) were included in our analysis.…”

Effect of Liposomal Curcumin on Acetaminophen Hepatotoxicity by Down-regulation of Oxidative Stress and Matrix Metalloproteinases

“…Both LCC concentrations were more efficient than silymarin pretreatment (Table I, Figure 3). TNF-α reduction was also demonstrated by oral curcumin administration or by other curcumin nanoformulations (66)(67)(68). The liposomal formulation of curcumin can enhance its anti-inflammatory properties through down-regulation of TNF-α due to its higher bioavailability, and a better distribution in therapeutic concentration at the injury site (69).…”

Metabolic and Clinical responses to Bunium Persicum (Black Caraway) supplementation in overweight and obese patients with type 2 diabetes: a double-blind randomized placebo-controlled clinical trial

“…Nesfatin gene expression is activated by peroxisome proliferator-activated receptors (PPARs), especially PPARγ (11,12) . Nesfatin-1 can decrease food intake when administered into the third cerebral ventricle of rats (13) .…”