A randomized, triple-blind, placebo-controlled clinical trial, evaluating the sesamin supplement effects on proteolytic enzymes, inflammatory markers, and clinical indices in women with rheumatoid arthritis

Inflammation is one of the main characteristics of rheumatoid arthritis. Based on the antiinflammatory properties of sesame, this study was conducted to evaluate the sesamin supplement effects on serum levels of some proteolytic enzymes, inflammatory biomarkers, and clinical indices in women with rheumatoid arthritis. In this randomized, triple‐blind, placebo‐controlled clinical trial, 44 patients were randomly divided in intervention and control groups. Patients received 200‐mg/day sesamin supplement or placebo in the intervention and control group for 6 weeks. Serum levels of proteolytic enzymes (hyaluronidase, aggrecanase, and matrix metalloproteinases‐3) and inflammatory biomarkers (hs‐CRP, IL‐1β, IL‐6, TNF‐α, and cyclooxygenase‐2) were measured with enzyme‐linked immunosorbent assay method at the beginning and end of the study. After intervention, serum levels of hyaluronidase and matrix metalloproteinases‐3 decreased significantly in sesamin group. Also, serum levels of hs‐CRP, TNF‐α, and cyclooxygenase‐2 in intervention group were significantly decreased in intervention group compared with placebo group. Sesamin supplementation also caused a significant reduction in the number of tender joints and severity of pain in these patients. According to the results, it seems that the sesamin by reducing inflammatory mediators can relieve clinical symptoms and pathological changes that caused by inflammatory impairment in patients with rheumatoid arthritis. KEYWORDS inflammatory factors, proteolytic enzymes, rheumatoid arthritis, sesami

Effect of a high-protein diet with β-cryptoxanthin supplementation on metabolic risk factors, oxidative and inflammatory biomarkers in non-alcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled clinical trial

Abstracts Background Excessive hepatic fat is associated with increased metabolic risk factors, production of inflammatory factors, and oxidative stress. High protein intake might trigger an increased hepatic lipid oxidation through an increase in hepatic energy expenditure. Furthermore, the majority of randomized controlled trials (RCT) in humans have failed to show whether carotenoids can be used to prevent and treat non-alcoholic fatty liver disease (NAFLD). However, it is notable and contradictory that NAFLD is rapidly escalating in Iran and other countries with lower intakes of fruit and vegetables (as sources of β-cryptoxanthin [β-CX] and carbohydrates) and higher intake of carbohydrates (as an agent of NAFLD); and the effects of β-CX and a high protein diet (HPD) on NAFLD need to be investigated further. Methods/design This study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for 12 weeks to receive daily β-CX 6 mg supplementation combined with a HPD on levels of metabolic factors, β-CX, glycemic and lipid profiles, inflammatory factors, adipocytokines, and body composition. Ninety-two eligible patients, aged 18–60 years, of both genders, who are obese and overweight (body mass index [BMI] 25–40 kg/m2) will be randomly assigned to four groups as follow: HPD + placebo; normal protein diet + β-CX (NPD + β-CX); HPD + β-CX; and NPD + placebo (control group). Two populations will be analyzed in this work. The intention-to-treat (ITT) population includes all patients who will be randomized, while the per-protocol (PP) population includes all individuals who complete the 12- week intervention (i.e. study completers). Discussion Our findings from this trial will contribute to the knowledge of the relationship between β-CX supplementation and a HPD on NAFLD patients and determination of optimal macronutrient ratios without energy restriction. Trial registration Iran clinical trials registry, IRCT2017060210181N10. Registered on 20 June 2017

The effect of vitamin D supplement on quality of sleep in adult people with sleep disorders

Background: Sleep quality may be directly related with vitamin D serum level. Some studies found that people with lower vitamin D serum level experienced a lower sleep quality. Consequently, this study aimed at determining the effect of vitamin D supplements on sleep point and quality in 20-50 year-old people with sleep disorders. Methods: This double-blind, clinical trial was performed in Golestan Hospital of Ahvaz Jundishapur Medical Sciences University from November 2015 to February 2016 on 89 people with sleep disorders based on Pittsburgh Sleep quality index (PSQI). Participants of the study were selected based on inclusion and exclusion criteria. Patients under study were divided into two groups of vitamin D supplement and placebo recipients by random allocation. At the end of the study, the data on 89 subjects (44 in intervention group and 45 people in placebo group) were examined. Participants in intervention group received four edible pearls, each 50000 IU vitamin D, one in a fortnight. To placebo group, a placebo capsule (edible paraffin) was given one in a fortnight. Before and after intervention, Petersburg’s sleep quality questionnaire, Depression Anxiety Stress Scale (DASS-21) questionnaire, international physical activity questionnaire, general information questionnaire, sun exposure, vitamin D serum level and three-day food record questionnaire were assessed and recorded for all participants. To analyze data, Student's t-test, Chi-square test, ANCOVA, Mann-Whitney U test and Wilcoxon statistical tests were used. Results: Mean score of Pittsburgh sleep quality questionnaire before and after intervention was 9.45±2.44 and 6.75±2.97 respectively (P=0.001) in interventional group and 10.51±3.14 and 9.73±3.04 respectively (P=0.18) in controls. Based on the results of the present study, at the end of the study score of Pittsburgh sleep quality questionnaire reduced significantly in vitamin D recipients as compared with placebo recipients (P=0.001). Conclusion: This study shows that the use of vitamin D supplement reduced sleep score (PSQI) or improved sleep score, reduced sleep latency, increased sleep duration and increased subjective sleep quality after modifying confounding variables in adult people with sleep disorder

Effect of Vitamin D Supplement on Anthropometric Indices of Overweight or Obese Individuals Suffering Sleep Disorder: A Randomized Clinical Trial

Background and Objectives: Obesity leads to cardiovascular diseases, diabetes, and hypertension. Sleep disorder can also cause obesity and overweight through changing the levels of neuropeptides, such as ghrelin and leptin as well as other mechanisms. In the present study, the effect of vitamin D supplement, was investigated on anthropometric indices in overweight or obese individuals with sleep disorder. &nbsp; Methods: In this double-blinded clinical trial study, statistical population consisted of 74 overweight or obese women and men (age, 20-50 years) with sleep disorder who referred to Golestan Hospital in Ahvaz city. The mean serum level of vitamin D in the studied subjects was less than 30ng/ml. In the treatment group, 50000 units of vitamin D was taken for 8 weeks (once per week), and in the&nbsp; placebo group, 4 pearls were taken for 8 weeks. Plasma level of 25(OH)D3, weight, body mass index, waist circumference, waist to hip ratio, sunlight exposure period, physical activity, and 3-day food recall, were measured at the beginning of the study and 8 weeks later. &nbsp; Results: Serum level of 25(OH)D3 significantly increased from 24.7ng/ml to 37.6ng/ml after 8 weeks of intervention in the treatment group (p<0.05). Waist circumference had a significantly change in the treatment group after 8 weeks of supplementation (p<0.05). &nbsp; Conclusion: The results of this study showed Vitamin D supplementation increased serum level of Vitamin D and reduced waist circumference in overweight or obese subjects suffering from sleep disorder. &nbsp; &nbsp

The effect of soy isoflavones supplementation on metabolic status in patients with non-alcoholic fatty liver disease: a randomized placebo controlled clinical trial

Abstract Background Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of this study is to evaluate the effect of soy isoflavones supplementation on metabolic status in patients with NAFLD. Methods In this randomized clinical trial, 50 patients with NAFLD were randomly allocated to either soy isoflavone or placebo groups for 12 weeks. The soy isoflavone group took 100 mg/d soy isoflavone and the placebo group took the similar tablets containing starch. Anthropometric indices, blood lipids, glycemic parameters and blood pressure were measured at the beginning and at the end of the study. Results At the end of week 12 the level of serum triglyceride (TG), low density lipoprotein (LDL) and total cholesterol (TC) was significantly decreased only in soy isoflavone group compared to baseline (P  0.05). Conclusions This study revealed that soy isoflavones could significantly reduce TG, LDL TC, WC and HC in NAFLD patients. Trial registration The Ethics committee of Ahvaz Jundishapur University of Medical Sciences approved the protocol of the present clinical research (IR.AJUMS.REC.1401.155). The study was in accordance with the Declaration of Helsinki. This study’s registered number and date are IRCT20220801055597N1 and 20.09.2022, respectively at https://fa.irct.ir

The effect of soy isoflavones on non-alcoholic fatty liver disease and the level of fibroblast growth factor-21 and fetuin A

Abstract A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Subjects were randomized to either receive two tablets of soy isoflavone (100 mg/day) or placebo. At week 12, the serum levels of alanine amino transferase (ALT), aspartate amino transferase (AST) and controlled attenuation parameter (CAP) score were significantly decreased only in the soy isoflavone group (P < 0.05). A significant decline in the gamma glutamyl transferase (GGT) level was observed only in the placebo group (P = 0.017). A significant increase in the serum level of fetuin A was shown in both groups at the end of the trial with a significantly greater increment in the soy isoflavone group compared to the placebo group (P < 0.05). The changes in the serum level of FGF-21 were not significant in any of the two groups. Steatosis grade significantly improved only in the soy isoflavone group (P = 0.045). There was no significant change in the fibrosis grade in the groups. Soy isoflavone intake led to a decrease in ALT, AST, CAP score, steatosis grade and an increase in the level of fetuin A. However, no significant changes were observed in the fibrosis grade and serum levels of GGT and FGF-21