Oral administration of alpha-lipoic acid did not affect lipid peroxidation and antioxidant biomarkers in rheumatoid arthritis patients.

Rheumatoid arthritis (RA) is a chronic inflammatory disease in which oxidative stress could play a substantial pathological role. Alpha-lipoic acid (ALA) has been known as a "universal" and "ideal" antioxidant. The purpose of this study was to investigate the effects of oral administration of Alpha-lipoic acid (ALA) on lipid peroxidation and antioxidant biomarkers in Rheumatoid arthritis (RA) patients. The study was a randomized, double-blinded, placebo-controlled clinical trial. 70 RA patients were randomized 1:1 to two groups using blocked randomization method and received 1200 mg/day ALA or placebo for 8 weeks. Fasting blood samples were obtained before and after the intervention to analyze total antioxidant capacity (TAC), antioxidant enzymes [superoxide dismutase (SOD), glutathione peroxidase (GSH-Px) and arylesterase (ARE) activities] and malondialdehyde (MDA). We observed significant increase in serum TAC (0.11 mmol/L; p=0.033) and ARE (13.76 U/mL; p=0.046) and significant decline in MDA (-0.36 nmol/L; p=0.002), in ALA group. However, these changes in ALA-treated group were not statistically significant when compared with placebo-treated group (p > 0.05). Also, within- and between-group differences of whole blood SOD and GSH-Px were not statistically significant (p > 0.05). In conclusion, unexpectedly, ALA therapy did not affect the oxidative status of RA patients in the present clinical trial. It seems that more comprehensive clinical trials in RA patients are still warranted to clarify the effectiveness of ALA which has been known as a potent antioxidant.

Effects of Alpha-Lipoic Acid Supplementation on Inflammatory Biomarkers and Matrix Metalloproteinase-3 in Rheumatoid Arthritis Patients.

OBJECTIVE: Although many studies have considered alpha-lipoic acid (ALA) as a potent antioxidant with anti-inflammatory functions in oxidative stress-associated inflammatory diseases, few studies have evaluated its efficacy in rheumatoid arthritis (RA). Therefore, we aimed to examine the effects of ALA on serum biomarkers of joint damage and inflammation in women with RA. METHODS: We performed a randomized, double-blind, placebo-controlled clinical trial in which RA patients (n = 70) aged 20-50 years were randomly assigned 1:1 to receive either ALA (1200 mg/day) or placebo for 8 weeks. Fasting blood samples were taken before and after the study to analyze inflammatory biomarkers including serum high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and serum matrix metalloproteinase-3 (MMP-3) as a marker of joint erosion. Moreover, 3-day dietary records, the International Physical Activity Questionnaire (IPAQ), and the Spielberger State-Trait anxiety inventory form Y (STAI-Y) were assessed before and after the intervention. RESULTS: Sixty-five RA patients completed the trial. No statistically significant differences were observed in serum levels of hs-CRP, TNF-α, IL-6, and MMP-3 within and between the ALA and placebo groups (p > 0.05). There were no statistically significant differences in dietary intakes, physical activity, and anxiety levels between groups at baseline and they remained statistically unchanged during the study period (p > 0.05). CONCLUSION: Although in theory ALA supplementation could serve as a beneficial nutraceutical in RA patients, in the present study serum inflammatory biomarkers and MMP-3 were not significantly affected by 8 weeks of ALA supplementation.

Stachys schtschegleevii tea, matrix metalloproteinase, and disease severity in female rheumatoid arthritis patients: a randomized controlled clinical trial.

BACKGROUND: Stachys schtschegleevii (SSC) is a herbal medicine used to treat infections. To date, this is the first study aimed to investigate the effects of SSC tea on disease activity score (DAS), serum inflammatory biomarkers and matrix metalloproteinases (MMP-1 and MMP-3) among women with rheumatoid arthritis (RA). METHODS: This pilot, triple-blind, randomized controlled clinical trial was conducted among forty-four women (age: 30-65 years) diagnosed with moderately active RA. Subjects were randomly assigned (1:1 ratio) into either SSC group (2.4 g/day SSC + 2.4 g/day black tea, n=22) or placebo (2.4 g/day black tea, n=22) for 8 weeks. Serum high-sensitivity C-reactive protein (hs-CRP), interleukin-1 beta (IL-1ß), and MMPs were measured using ELISA. According to the American College of Rheumatology guideline considering hs-CRP, DAS28 was assessed. RESULTS: Both study groups had respondent rates above 94.9%. The SSC intervention caused significant reductions in the number and the percent changes of the tender joints (SSC: -74.39% vs. placebo: -57.15%, mean differences= -0.77; P<0.05) and DAS28 [SSC: -32.44% vs. placebo: -22.32%, mean differences= -0.41, P<0.05). Unlike the intervention within SSC group that showed significant reductions in the mean serum levels of hs-CRP, IL-1ß, and MMP-3, SSC caused significant MMP-3 reductions (SSC: -20.59% vs. placebo: 1.29%, P<0.05). CONCLUSION: The SSC intervention showed an appropriate clinical efficacy for female RA patients, accompanying remarkable reductions in the number of tender and swollen joints, DAS28, and serum levels of MMP-3. This can provide additional insights to the interventional studies controlling RA-related pathological and inflammatory outcomes. Trial registration Prospectively registered at the Iranian Registry of Clinical Trials (IRCT), linked to the WHO Registry Network ( https://en.irct.ir/trial/11602 , IRCT registration number: IRCT2015032011335N5, Registration date:2015-05-12). Key Points • Stachys schtschegleevii improved clinical outcomes and attenuated disease severity in RA patients. • Stachys schtschegleevii ameliorated serum level of MMP-3 in RA patients.

Changes of Insulin Resistance and Adipokines Following Supplementation with Glycyrrhiza Glabra L. Extract in Combination with a Low-Calorie Diet in Overweight and Obese Subjects: a Randomized Double Blind Clinical Trial.

Purpose: Adipose tissue is a highly active endocrine organ which plays a key role in energy homeostasis. The aim of this study was to determine the effects of dried licorice extract along with a calorie restricted diet on body composition, insulin resistance and adipokines in overweight and obese subjects. Methods: Sixty-four overweight and obese volunteers (27 men, 37 women) were recruited into this double-blind, placebo-controlled, randomized, clinical trial. Participants were randomly allocated to the Licorice (n=32) or the placebo group (n=32), and each group received a low-calorie diet with either 1.5 g/day of Licorice extract or placebo for 8 weeks. Biochemical parameters, anthropometric indices, body composition and dietary intake were measured at baseline and at the end of the study. Results: A total of 58 subjects completed the trial. No side effects were observed following licorice supplementation. At the end of the study, waist circumference, fat mass, serum levels of vaspin, zinc-α2 glycoprotein, insulin and HOMA-IR were significantly decreased in the intervention group, but only the reduction in serum vaspin levels in the licorice group was significant when compared to the placebo group (p<0.01). Conclusion: Supplementation with dried licorice extract plus a low-calorie diet can increase vaspin levels in obese subjects. However, the anti-obesity effects of the intervention were not stronger than a low-calorie diet alone in the management of obesity.

The Effect of Dried Glycyrrhiza Glabra L. Extract on Obesity Management with Regard to PPAR-γ2 (Pro12Ala) Gene Polymorphism in Obese Subjects Following an Energy Restricted Diet.

Purpose: Obesity is a multi-factorial health problem which results from the interaction of environmental and genetic factors. The aim of the present study was to determine the effects of dried licorice extract with a calorie restricted diet on anthropometric indices and insulin resistance with nutrigenetic approach. Methods: For this pilot, double-blind, placebo-controlled randomized clinical trial, 72 eligible subjects were randomly allocated to Licorice or placebo group. They received a low-calorie diet either with a 1.5 g/day of Licorice extract or placebo for 8 weeks. Results: There were no significant differences in anthropometric indices and dietary intake in genotype subgroups at the baseline. Findings indicated that supplementation with Licorice extract did not change anthropometric indices and biochemical parameters significantly compared to a hypocaloric diet alone. However, from the nutrigenetic point of view, significant changes in anthropometric indices and QUICKI were observed in the Pro12Pro genotypes compared to the Pro12Ala at the end of the study (p<0.05 in all variables). Moreover, no interactive effect of the Licorice supplement and Pro12Ala genotype was found. Conclusion: In obese subjects, the Pro/Pro polymorphism of the PPAR-γ2 gene seems to induce favourable effects on obesity management. Further studies are needed to clarify whether PPAR-γ2 gene polymorphisms or other obesity genes can affect responses to obesity treatment.

A Combination of Prebiotic Inulin and Oligofructose Improve Some of Cardiovascular Disease Risk Factors in Women with Type 2 Diabetes: A Randomized Controlled Clinical Trial.

PURPOSE: This trial was conducted to evaluate the effects of oligofructose-enriched inulin on some of cardiovascular disease risk factors in women with type 2 diabetes. METHODS: 52 females (25