Effectiveness of the pomegranate extract in improving hepatokines and serum biomarkers of non-alcoholic fatty liver disease: A randomized double blind clinical trial.

BACKGROUND AND AIM: Pomegranate as a functional food has various properties and effects on health. The aim of the study was to evaluate the effect of pomegranate extract on serum levels of liver enzymes, hepatokines, interleukin-6 (IL-6), and total antioxidant capacity in non-alcoholic fatty liver disease (NAFLD). METHODS: In this double-blind randomized clinical trial, 44 patients with NAFLD were divided into two groups: pomegranate extract tablets and placebo. The intervention period was 12 weeks. At the beginning and end of the study, serum levels of alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), fetuin-A, fibroblast growth factor 21 (FGF-21), interleukin-6 (IL-6), and total antioxidant capacity were assessed in both groups. RESULTS: Pomegranate extract reduced the level of ALT (P < 0.001), AST (P < 0.001), GGT (P < 0.001), fetuin-A (P < 0.001), FGF-21(P < 0.001) and IL-6 (P = 0.04) compared to the placebo. Pomegranate extract also led to an increase in total antioxidant capacity (P˂0.001) but had no effect on ALP. CONCLUSION: It seems that the pomegranate extract improves several markers of NAFLD, and can be useful as a treatment supplement. The clinical trial approved by Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences (grant No. NRC-9811). TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT), IRCT20140107016123N14, https://www.irct.ir/trial/42739.

Effects of propolis supplementation on irritable bowel syndrome with constipation (IBS-C) and mixed (IBS-M) stool pattern: A randomized, double-blind clinical trial.

Background: Recent evidence indicates that propolis can modulate gastrointestinal (GI) function. This trial aims to assess the efficacy of propolis supplementation on the severity of irritable bowel syndrome (IBS) symptoms. Methods: This clinical trial was conducted on 56 subjects with IBS diagnosed by Rome IV criteria. Eligible subjects were randomly assigned to receive either 900 mg/day of propolis or matching placebo tablets for 6 weeks. The IBS symptom severity scale (IBS-SSS) was used to evaluate IBS severity in five clinically applicable items. Results: After adjusting anxiety scores, a significant reduction was observed in the overall score of IBS symptoms (-98.27 ± 105.44), the severity of abdominal pain (-24.75 ± 28.66), and the frequency of abdominal pain (-2.24 ± 3.51) with propolis treatment as compared to placebo (p-value < .05). Patients in the propolis group were 6.22 times more likely to experience improvement in IBS symptoms than those in the placebo group (95% CI: 1.14-33.9; p-value: .035). There was no significant change in anthropometric measurements and dietary intakes in both groups (p-value > .05). Conclusions: Our results showed that propolis supplementation might have a beneficial effect on constipation subtype of IBS (IBS-C) and mixed subtype of IBS (IBS-M) severity by reducing the severity and frequency of abdominal pain in patients with irritable bowel syndrome (IBS).

The effect of pomegranate extract on anthropometric indices, serum lipids, glycemic indicators, and blood pressure in patients with nonalcoholic fatty liver disease: A randomized double-blind clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease. The beneficial effects of pomegranate have been shown on insulin resistance and obesity, which are linked to NAFLD pathogenesis. The aim of this study was to investigate the efficacy of pomegranate extract in patients with NAFLD. Forty-four NAFLD patients were randomly assigned to receive two pomegranate extract tablets or placebo for 12 weeks. Anthropometric measurements, serum lipids, glycemic indicators, and blood pressure were assessed at baseline and the end of the study. Pomegranate was associated with a reduction in the total cholesterol (p Ë‚ .001), triglyceride (p Ë‚ .001), low-density lipoprotein cholesterol (LDL-C)-to-high-density lipoprotein cholesterol (HDL-C) ratio (p Ë‚ .003), fasting blood sugar (p Ë‚ .001), homeostatic model assessment of insulin resistance (p = .02), diastolic blood pressure (p = .04), weight (p Ë‚ .001), body mass index (p Ë‚ .001), and waist circumference (p = .002), as compared to placebo. A significant increase was observed in serum HDL-C (p Ë‚ .001) after intervention with the pomegranate extract. However, no significant difference was shown between the two groups in serum insulin and LDL-C. The pomegranate extract supplement could be used as a complementary therapy along with existing therapies to improve glycemic indicators, serum lipids, anthropometric indices, and blood pressure in patients with nonalcoholic fatty liver.

The effect of melatonin on treatment of patients with non-alcoholic fatty liver disease: a randomized double blind clinical trial.

OBJECTIVES: Many factors implicated in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) are including oxidative stress, insulin resistance and abnormal production of adipokines. The aim of this clinical trial was to evaluate the effect of melatonin supplement on some important biochemical markers and signs related to NAFLD. DESIGN: A randomized double-blind, placebo-controlled, clinical trial. SETTING: Twenty-four participants in the melatonin group and 21 participants in the placebo group completed the study. INTERVENTION: Participants received 6 mg melatonin or placebo daily, 1 h before bedtime. The intervention period was 12 weeks. MAIN OUTCOME MEASURES: Anthropometric measurements, systolic and diastolic blood pressure, liver enzymes, high sensitive C­reactive protein (hs-CRP), fatty liver grade, also leptin and adiponectin serum levels, were measured at the baseline and the end of intervention. RESULTS: A significant improvement was observed in weight (p = 0.043), waist circumference (p = 0.027), abdominal circumference (p = 0.043), systolic (p = 0.039), and diastolic (p = 0.015) blood pressure, leptin serum levels (p = 0.032), hs-CRP (p = 0.024), alanine aminotransferase (p = 0.011), aspartate aminotransferase (p = 0.034), also the grade of fatty liver (p = 0.020) in melatonin treated group compared with the placebo. CONCLUSIONS: Administration of 6 mg/day melatonin had improvement effect on many factors related to NAFLD such as liver enzymes, hs-CRP, anthropometric measurements, blood pressure, leptin serum levels and the grade of fatty liver.

Effects of Concurrent Omega-3 and Cranberry Juice Consumption Along with Standard Antibiotic Therapy on the Eradication of Helicobacter pylori, Gastrointestinal Symptoms, Some Serum Inflammatory and Oxidative Stress Markers in Adults with Helicobacter pylori Infection: A Study Protocol for a Randomized Controlled Trial.

BACKGROUND: It seems alternative treatments such as antioxidant intervention and anti-inflammatory intervention adjuvant to antibiotic regimens may enhance cancer prevention approaches and decrease adverse side effects related to therapeutic antibiotic regimens. So, we will evaluate the effects of concurrent omega-3 and cranberry juice supplementation along with standard antibiotic therapy on the eradication of Helicobacter pylori, gastrointestinal symptoms, some serum inflammatory and oxidative stress markers in adults with HP infection. METHODS: We will conduct a 4-week double-blinded randomized clinical trial. The subjects will be randomly stratified according to sex and BMI using a permuted block randomization procedure by Random Allocation Software (RAS). They will be assigned to one of the four study groups: (1) cranberry juice fortified with omega-3 Intervention (n=23), (2) cranberry juice intervention group (n=23), (3) placebo beverage fortified with omega-3 intervention group (n=23), and (4) placebo beverage intervention (control group) (n=23). All statistical analyses will be performed using IBM SPSS Statistics software. DISCUSSION: A combination of alternative therapies may have a synergistic effect compared to a single approach. It could potentially be more effective in promoting the efficacy of standard antibiotic therapy in eradicating HP infection. TRIAL REGISTRATION: Iranian Registry of Clinical Trials (IRCT20151128025274N3, www.irct.ir/trial/28997). TRIAL STATUS: This study is in the early stages of sampling.

Evaluation of argon plasma coagulation in healing of a solitary rectal ulcer in comparison with conventional therapy: a randomised controlled trial.

INTRODUCTION: Argon plasma coagulation (APC) has been reported to be effective in the treatment of solitary rectal ulcer syndrome (SRUS). However, it has not appeared to be effective in healing ulcers. AIM: This study aimed at assessing the effectiveness of APC in controlling rectal ulcer-induced bleeding, and at examining the ultimate effect of this approach in healing these lesions. MATERIAL AND METHODS: This randomised, controlled trial was conducted on 99 patients with SRUS. Patients were randomly enrolled into two groups of APC therapy (intervention) and conventional therapy (control). The control group (n = 58) received a high-fibre diet, laxatives, behaviour therapy, and sucralfate enemas, and the intervention group (n = 41) were treated with APC plus conventional therapy; in fact they received directed and focused argon gas in addition to a high-fibre diet and laxatives. RESULTS: Responses to treatment in the control group and in the APC-receiving group were 29.3% and 75.6%, respectively. The continuation of ulcer healing after 3 months in the control group was 10.3%, and it was 70.7% in the APC-treated group. There was a significant statistical difference between the two groups (p < 0.004), i.e. bleeding was controlled more frequently in the group receiving APC plus conventional therapies than in the group receiving only the conventional therapies. However, the results showed no statistically significant difference between the two groups in terms of pain relief (p < 0.36). CONCLUSIONS: Argon plasma coagulation not only controlled bleeding in patients with SRUS, but also, in comparison with the conventional methods of treating SRUS, led to healing and continuation of healing of rectal ulcers.