The effect of curcumin and high-content eicosapentaenoic acid supplementations in type 2 diabetes mellitus patients: a double-blinded randomized clinical trial.

BACKGROUND/OBJECTIVES: The present study investigated the effect of curcumin and eicosapentaenoic acid, as one the main components of omega-3 polyunsaturated fatty acids, on anthropometric, glucose homeostasis, and gene expression markers of cardio-metabolic risk in patients with type 2 diabetes mellitus. SUBJECTS/METHODS: This clinical trial was conducted at the Endocrinology Clinic of Imam Reza Hospital in Tabriz. It aimed to determine the impact of Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), and curcumin supplements on various health indicators in patients with Type 2 Diabetes Mellitus (DM2) from 2021.02.01 to 2022.02.01. The study was a randomized double-blinded clinical trial and conducted over 12 weeks with 100 participants randomly divided into four groups. Stratified randomization was used to assign participants to two months of supplementation based on sex and Body Mass Index (BMI). The study comprised four groups: Group 1 received 2 capsules of 500 mg EPA and 200 mg DHA, along with 1 nano-curcumin placebo; Group 2 received 1 capsule of 80 mg nano-curcumin and 2 omega 3 Fatty Acids placebos; Group 3 received 2 capsules of 500 mg EPA and 200 mg DHA, and 1 capsule of 80 mg nano-curcumin; Group 4, the control, received 2 omega 3 Fatty Acids placebos and 1 nano-curcumin placebo. RESULTS: After twelve weeks of taking EPA + Nano-curcumin supplements, the patients experienced a statistically significant reduction in insulin levels in their blood [MD: -1.44 (-2.70, -0.17)]. This decrease was significantly greater than the changes observed in the placebo group [MD: -0.63 (-1.97, 0.69)]. The EPA + Nano-curcumin group also showed a significant decrease in High-Sensitivity C-Reactive Protein (hs-CRP) levels compared to the placebo group (p < 0.05). Additionally, the EPA + Nano-curcumin group had a significant increase in Total Antioxidant Capacity (TAC) levels compared to the placebo group (p < 0.01). However, there were no significant differences in Fasting Blood Sugar (FBS), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, Quantitative Insulin Sensitivity Check Index (QUICKI), or Hemoglobin A1c (HbA1C) levels between the four groups (all p > 0.05). There were significant differences between the Nano-curcumin and EPA groups [MD: -17.02 (-32.99, -1.05)], and between the Nano-curcumin and control groups [MD: -20.76 (-36.73, -4.79)] in terms of lowering the serum cholesterol level. The difference in Triglycerides (TG) serum levels between the EPA + Nano-curcumin and placebo groups were not statistically significant (p = 0.093). The Nano-curcumin group showed significant decreases in Low-Density Lipoprotein (LDL) levels compared to the EPA group [MD: -20.12 (-36.90, -3.34)] and the control group [MD: -20.79 (-37.57, -4.01)]. There was a near-to-significant difference in High-Density Lipoprotein (HDL) serum levels between the EPA + Nano-curcumin and EPA groups (p = 0.056). Finally, there were significant differences in the decrease of serum Vascular Endothelial Growth Factor (VEGF) levels between the EPA and Nano-curcumin groups [MD: -127.50 (-247.91, -7.09)], the EPA and placebo groups [MD: 126.25 (5.83, 246.66)], the EPA + Nano-curcumin and Nano-curcumin groups [MD: -122.76 (-243.17, -2.35)], and the EPA + Nano- curcumin and placebo groups [MD: 121.50 (1.09, 241.92)]. CONCLUSIONS: The findings of the present study suggest that 12-week supplementation with EPA and Nano-curcumin may positively impact inflammation, oxidative stress, and metabolic parameters in patients with diabetes. The supplementation of EPA and Nano-curcumin may be a potential intervention to manage diabetes and reduce the risk of complications associated with diabetes. However, further research is needed to validate the study's findings and establish the long-term effects of EPA and Nano-curcumin supplementation in patients with diabetes.

Effects of adjuvant ozone autohemotherapy combined with routine treatment on clinical and paraclinical features of mechanically ventilated COVID-19 patients in the intensive care unit: a pilot randomized controlled trial.

Until the availability of an effective and practical vaccine, there is a serious need to recognize alternative treatments for coronavirus disease 2019 (COVID-19). This study aimed to determine whether major ozonated autohemotherapy (MOAH) can improve the clinical and paraclinical parameters in critically-ill patients with COVID-19 requiring mechanical ventilation. In this controlled trial, we enrolled 40 critically ill COVID-19 patients receiving invasive mechanical ventilation. The enrolled patients were then randomized into the MOAH and control groups. The patients in the MOAH group received MOAH three times per week (10 times in total) in addition to routine treatment and standard critical supportive care. Patients in the control group were only given regular treatment and standard critical supportive care. The patients in the MOAH group had more days of breathing with no aid than those in the control group. Moreover, the length of stay in the intensive-care unit was significantly lower in the MOAH group than in the control group. MOAH resulted in higher ventilation-free days and less intensive-care unit stay compared with the control treatment. In COVID-19 patients undergoing mechanical ventilation, MOAH with routine treatment resulted in more ventilator-free days and less intensive-care unit stay compared with the standard therapy.

The effect of probiotic supplementation on the clinical and para-clinical findings of multiple sclerosis: a randomized clinical trial.

Multiple Sclerosis (MS) is a chronic demyelination disease of the central nervous system (CNS). The gut-brain axis involves communication between the nervous, endocrine, and immune systems. Probiotics can positively impact immune and inflammatory responses by regulating gut microbiota. A total of 40 MS patients (average age of 34.38 ± 6.65) were examined to determine the effect of the Saccharomyces boulardii supplement for four months compared to a placebo. The results showed that the Saccharomyces boulardii significantly decreased the inflammatory marker high-sensitivity C-reactive protein (hs-CRP) compared to the placebo (P < 0.001). The serum antioxidant capacity (TAC) also increased significantly in the probiotic group compared to the placebo (p = 0.004). Both the probiotic and placebo groups showed a reduction in the oxidative stress indicator malondialdehyde (MDA), but there was no significant difference between the two groups. Pain intensity (measured by Visual Analogue Scale) and fatigue severity (measured by Fatigue Severity Scale) significantly decreased in the probiotic group compared to the placebo (p = 0.004 and p = 0.01, respectively). The probiotic group experienced significant improvement in some quality of life scales (measured by 36-Item Short Form Survey) and somatic and social dysfunction subscale of General Health Questionnaire scores compared to the placebo group (p = 0.01). The study suggests that the Saccharomyces boulardii probiotic supplement may benefit inflammatory markers, oxidative stress indicators, pain, fatigue, and quality of life in MS patients.

The Relationship Between Usual Daily Physical Activity With Serum Markers Related to Bone Metabolism and Demographic Characteristics in Postmenopausal Women Aged 50-65 Years.

BACKGROUND: Bone turnover markers can predict subsequent changes in bone status. This study aimed to investigate the relationship between usual daily physical activity (PA) with bone markers. METHODS: This cross-sectional study was conducted on 500 postmenopausal women aged 50-65 years in Tabriz-Iran in 2018. The women were recruited by a simple random method. The International Physical Activity Questionnaire was used to assess PA. The laboratory tests of 25-Hydroxyvitamin D3, alkaline phosphatase, calcium, and phosphorus were also used to examine bone function. RESULTS: The education, income, employment status, sun exposure, and history of exercise were significantly correlated with PA. Among reproductive characteristics, only menopausal age showed a significant relationship with total PA levels (r = .285, P = .048). None of the anthropometric indices showed a statistically significant relationship with total PA. Serum calcium (r = -.242) and phosphorus (r = -.045) levels showed negative and inverse relationships with total PA. The intensity of this association was statistically significant only for the calcium (ß = -0.108, 95% confidence interval, -0.117 to 0.098; P = .023). 25-Hydroxyvitamin D3 (r = .007) and alkaline phosphatase (r = .046) were directly and positively but nonsignificantly correlated to the intensity of total PA. CONCLUSION: Usual daily physical activity with any levels has no effect on bone markers except for calcium. Despite of the beneficial effects of PA, our findings showed that usual daily physical activity without increasing total PA cannot affect bone health. For maximal effects of PA on bone health, it seems that a degree of intensity, continuity, and regularity of PA programs should be considered to stimulate bone formation.

Efficacy of nanomicelle curcumin, Nigella sativa oil, and their combination on bone turnover markers and their safety in postmenopausal women with primary osteoporosis and osteopenia: A triple-blind randomized controlled trial.

Literature supports the potential effects of nanomicelle curcumin and Nigella sativa on the amelioration of osteoporosis, a health concern of postmenopausal women. This study aimed to evaluate the impacts of nanomicelle curcumin (CUR), Nigella sativa oil (NS), and their combination on bone turnover biomarkers and assess their safety. This triple-blind randomized controlled trial was performed on 120 postmenopausal women aged 50-65 with primary osteoporosis or osteopenia. The subjects were randomly allocated to receive microcrystalline cellulose (placebo), 80 mg of CUR, 1000 mg of NS, or their combination (CUR-NS) for 6 months. All patients were also treated with alendronate (70 mg) and calcium (500 mg), vitamin D (400 IU) supplements. The serum levels of alkaline phosphatase (ALP), osteocalcin (OC), and osteopontin (OP) were measured at the baseline and after the intervention. For safety assessment, the hepatic enzyme levels of aspartate transaminase and alanine transaminase as well as serum urea and creatinine were evaluated. ALP levels were significantly reduced in the NS (p = .029) and CUR-NS (p = .015) groups compared with those in the placebo. After adjustment for the covariates, this effect was still significant in the CUR-NS group (p = .004). The OC levels were decreased in the placebo, CUR, and NS groups, and the OP concentration also was attenuated in all groups through the trial. However, the intergroup differences were not significant for both biomarkers. Evaluating the key renal metabolites and hepatic enzyme levels indicated no toxicity of the administered doses. This study reveals the beneficial effects of CUR-NS on the improvement of some bone turnover biomarkers. These compounds seem to be safe at the current dosage for supplementation in postmenopausal women.

Effect of berry-based supplements and foods on cognitive function: a systematic review.

In the current decade, a growing body of evidence has proposed the correlation between diet and cognitive function or dementia in the ageing population. This study was designed to appraise discoveries from the randomized controlled trials to confirm the effects of berry-based supplements or foods on cognitive function in older adults. PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, EMBASE, Google Scholar, and ProQuest as well as SID, Magiran, and Iranmedex electronic databases were explored for human interventional studies up to March 2021. In total, eleven articles were identified using frozen blueberry (n = 4 studies), blueberry concentrate (n = 2), beverage (n = 3), capsule (n = 1), extract and powder (n = 1). These studies had been performed among older people with no recognized cognitive impairment or mild cognitive impairment (MCI). The primary outcomes included global cognitive function, psychomotor function, learning and memory, working memory capacity, executive functions, and brain perfusion/activity. To our knowledge, this is the first systematic review of available clinical trials on the effects of berry-based supplements and foods on cognitive performances as well as brain perfusion parameters among the elderly with normal cognition or MCI. Existing evidence concludes that berry-based supplements and foods have beneficial effects on resting brain perfusion, cognitive function, memory performance, executive functioning, processing speed, and attention indices.

Nutraceutical supplements in management of pain and disability in osteoarthritis: a systematic review and meta-analysis of randomized clinical trials.

This study designed to evaluate the effect of nutraceutical supplementation on pain intensity and physical function in patients with knee/hip OA. The MEDLINE, Web of Science, Cochrane Library, Scopus, EMBASE, Google Scholar, Science direct, and ProQuest in addition to SID, Magiran, and Iranmedex were searched up to March 2020. Records (n = 465) were screened via the PICOS criteria: participants were patients with hip or knee OA; intervention was different nutritional supplements; comparator was any comparator; the outcome was pain intensity (Visual analogue scale [VAS]) and physical function (Western Ontario and McMaster Universities Arthritis [WOMAC] index); study type was randomized controlled trials. The random effects model was used to pool the calculated effect sizes. The standardized mean difference (SMD) of the outcome changes was considered as the effect size. The random effects model was used to combine the effect sizes. Heterogeneity between studies was assessed by Cochran's (Q) and I2 statistics. A total of 42 RCTs were involved in the meta-analysis. Nutritional supplementation were found to improve total WOMAC index (SMD = - 0.23, 95% CI - 0.37 to - 0.08), WOMAC pain (SMD = - 0.36, 95% CI - 0.62 to - 0.10) and WOMAC stiffness (SMD = - 0.47, 95% CI - 0.71 to - 0.23) subscales and VAS (SMD = - 0.79, 95% CI - 1.05 to - 0.05). Results of subgroup analysis according to the supplementation duration showed that the pooled effect size in studies with < 10 months, 10-20 months and > 20 months supplementation duration were 0.05, 0.27, and 0.36, respectively for WOMAC total score, 0.14, 0.55 and 0.05, respectively for WOAMC pain subscale, 0.59, 0.47 and 0.41, respectively for WOMAC stiffness subscale, 0.05, 0.57 and 0.53, respectively for WOMAC physical function subscale and 0.65, 0.99 and 0.12, respectively for VAS pain. The result suggested that nutraceutical supplementation of patients with knee/hip OA may lead to an improvement in pain intensity and physical function.

Comparison of efficacy of corticosteroid injection versus extracorporeal shock wave therapy on inferior trigger points in the quadratus lumborum muscle: a randomized clinical trial.

BACKGROUND: In this study, we aimed to compare the efficacy of corticosteroid trigger point injection (TPI) versus extracorporeal shock wave therapy (ESWT) on inferior trigger points in the quadratus lumborum (QL) muscle. METHODS: In this single-blind randomized clinical trial, 54 low back pain patients with myofascial trigger points on QL muscle were investigated. Participants were randomly allocated into two groups with A and B pockets. Patients in group A underwent radial ESWT and received 5 treatment sessions (1 per week) and actually were not followed-up. However, patients in group B received corticosteroid TPI and received one session of corticosteroid treatment and followed-up for 4 weeks after injection. Oswestry Disability Index (ODI), visual analogue scale (VAS), pain pressure threshold (PPT) and short form (36) health survey (SF-36) were measured in both groups before, two weeks after and four weeks after intervention. RESULTS: The between group comparison indicated that corticosteroid TPI leaded to significant higher improvements of ODI (P-value< 0.01), VAS (P value< 0.001), and PPT (P-value = 0.001) scores compared to the ESWT group at two-week follow-up time-point. ESWT group recorded significant higher improvement of ODI (P-value< 0.01) and SF-36 (P-value< 0.001) compared to the corticosteroid TPI at 4th week post treatment evaluation. At four-week follow-up time-point, the patients in the ESWT group were 1.46 times more likely to achieve 30% reduction in VAS, 2.67 times more likely to achieve 30% reduction in ODI, and 2.30 times more likely to achieve 20% improvement in SF-36 compared to the participants in corticosteroid TPI group. These results refer to large effect size for all study outcomes in ESWT group (d = 4.72, d = 1.58, d = 5.48, and d = 7.47 for ODI, PPT, SF-36, and VAS, respectively). CONCLUSION: Corticosteroid TPI was more effective compared to ESWT in short-term controlling of pain and disability caused by myofascial pain syndrome of QL muscle. However, after 4 weeks treatment, ESWT further improved the quality of life and disability and was related with more probability of achievement the minimal clinically important difference concerning pain, disability and quality of life and large effect size for all study outcomes in treated patients compared to corticosteroid TPI. TRIAL REGISTRATION: www.irct.ir , IRCT20100827004641N14 , retrospectively registered 2019-01-19.

Ginger (Zingiber officinale) and turmeric (Curcuma longa L.) supplementation effects on quality of life, body composition, bone mineral density and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis: a study protocol for a randomized controlled clinical trial.

OBJECTIVES: Phytomedicine is widely suggested for the prevention of chronic disease, but evidence for a favorable effect on bone health is lacking. The present study will investigate the Zingiber officinale (ZO) and Curcuma longa L. (CL) supplementation effects on quality of life, body composition, bone mineral density (BMD) and osteoporosis related biomarkers and micro-RNAs in women with postmenopausal osteoporosis (PMO). METHODS: This study protocol is designed as prospective triple-blind randomized controlled trial. One hundred and 20 patients with PMO will be enrolled in a 4 month, prospective, triple-blind, placebo-controlled trial and randomly assigned to four groups: ZO (500 mg b.i.d.) + CL (500 mg b.i.d.) (ZO + CL); ZO (500 mg b.i.d.) + placebo CL (b.i.d.) (ZO + P); placebo ZO (b.i.d.) + CL (500 mg b.i.d.) (CL + P); and placebo ZO (b.i.d.) + placebo CL (b.i.d.) (P + P). Quality of life, body composition and BMD will be defined as the primary endpoints and osteoporosis related serum biomarkers and circulating micro-RNAs will be defined as the secondary endpoints. The ANCOVA statistical method will be used to investigate the effect of the interventional variables on the response variable. CONCLUSION: To our knowledge, this trial is the first clinical study exploring the effect of Ginger and turmeric on quality of life, body composition, BMD and osteoporosis related biomarkers and micro-RNAs in women with PMO. The findings of this trial could be the basis for the development of harmless and inexpensive preventive and therapeutic approaches for PMO.

Relative Effectiveness of Electroacupuncture and Biofeedback in the Treatment of Neck and Upper Back Myofascial Pain: A Randomized Clinical Trial.

OBJECTIVE: To determine the differences between clinical effects of electroacupuncture and biofeedback therapy in addition to conventional treatment in patients with cervical myofascial pain syndrome (MPS). DESIGN: Randomized clinical trial. SETTING: Physical medicine and rehabilitation clinic of a university hospital. PARTICIPANTS: Fifty patients (N=50) aged 25-55 years of both sexes with chronic neck pain diagnosed with MPS (characterized by trigger points within taut bands) were randomly assigned to 2 equal groups of 25 individuals. INTERVENTIONS: The patients in electroacupuncture group were treated with standard acupuncture and concomitant electrical stimulation; those in biofeedback group received visual electromyography biofeedback therapy for muscle activity and relaxation. Both groups received the intervention 2 times a week for a total of 6 sessions. Basic exercise training and medicines were administered for all the patients. MAIN OUTCOME MEASURES: Pain severity based on the visual analog scale (VAS), functional status using Neck Disability Index (NDI), cervical range of motion (ROM) using and inclinometer, and pressure pain threshold (PPT) using an algometer were evaluated before and at 3 and 12 weeks after the treatment. Primary outcome was defined as 20% reduction in the 3-month neck pain and dysfunction compared to baseline, assessed through the NDI. RESULTS: Fifty patients (39 women, 11 men) with a mean age (years) ± SD of 39.0±5.5 and neck pain duration (weeks) of 6.0±2.2 were analyzed. All parameters, except for PPT of the lower trapezius and paravertebral muscles were improved significantly in both groups, while baseline values were controlled. The primary outcome was achieved more significantly in the acupuncture group than in the biofeedback group: 20 (80.0%) vs 10 (40.0%); rate ratio=2 with 95% confidence interval (CI), 1.19-3.36; number needed to treat (NNT)=2.5 with 95% CI, 1.54-6.58. Advantages of acupuncture over biofeedback were observed according to values obtained from the NDI, VAS, extension and left lateral-bending ROM, and PPT on the left upper trapezius after the last session of intervention until 3 months (P<.05). CONCLUSIONS: Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment. However, intergroup differences showed priority of acupuncture in some parameters vs biofeedback. Thus, electroacupuncture seems to be a better complementary modality for treatment of MPS in the neck and upper back area.

The effects of probiotic Saccharomyces boulardii on the mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in patients with multiple sclerosis: study protocol for a double-blind randomized controlled clinical trial.

BACKGROUND: The relationship between gut dysbiosis and inflammatory diseases including multiple sclerosis (MS) is presently recognized as an important health issue. It has been established that some bacterial probiotic strains are effective in treating MS. This study will investigate the effect of yeast probiotic Saccharomyces boulardii (SB) supplements on mental health, quality of life, fatigue, pain, and indices of inflammation and oxidative stress in MS patients. METHODS/DESIGN: In this double-blind randomized controlled two-group parallel trial, 50 MS patients who meet the inclusion criteria will be recruited from outpatient settings. They will be randomly allocated to 4 months of daily placebo or the SB probiotic intervention. Blood samples will be taken from each participant at the baseline and after the intervention period to assess inflammation and oxidative stress. The primary endpoint will be the changes in their mental health evaluated by the 28-item General Health Questionnaire. The secondary endpoints include changes in: (1) quality of life, evaluated by the 36-item Short Form Questionnaire, (2) fatigue, evaluated by the Fatigue Severity Scale, (3) pain, evaluated by a visual analogue scale, and (4) serum levels of indices of inflammatory stress (high-sensitivity C-reactive protein) and oxidative stress (malondialdehyde and total antioxidant capacity). Moreover, any adverse events and side effects due to the intervention will be documented. DISCUSSION: There is a need to discover safe and practical methods for managing the symptoms of MS. This trial will gather evidence on the effects of a probiotic. TRIAL REGISTRATION: Iranian Clinical Trial Registry, IRCT20161022030424N1 . Registered on 9 April 2018.

Maternal and Neonatal Metabolic Outcomes of Vitamin D Supplementation in Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis.

INTRODUCTION: Many scientists have revealed the association between vitamin D deficiency and gestational diabetes mellitus (GDM). The purpose of this review was to evaluate the impact of vitamin D supplementation on maternal and neonatal health measures in GDM. METHODS: A comprehensive systematic literature search in the electronic databases including Cochrane Central Register of Controlled Trials, MEDLINE (PubMed), Scopus, Web of Sciences, EMBASE, Google Scholar, Clininaltrial.gov, and ProQuest as well as SID, Magiran, Irandoc, and Iranmedex for Persian literature review carried out up to January 2018. All RCTs and quasi-experimental studies that compared vitamin D supplementation with placebo or without supplementation on GDM women were included in this review. RESULTS: Five randomized controlled trials involving 310 women were included in the meta-analysis. There were significant differences in fasting Plasma Glucose (FPG; mean difference [MD] -12.54, 95% CI -15.03 to -10.05; 3 trials, 223 participants); total cholesterol (TC; MD -24.77, 95% CI -32.57 to -16.98; 3 trials, 223 participants); low-density lipoprotein (LDL) cholesterol (MD -18.92, 95% CI -24.97 to -12.88; 3 trials, 223 participants); high-density lipoprotein (HDL) cholesterol (MD, 3.87, 95% CI 1.20-6.55; 3 trials, 223 participants); high sensitivity C-reactive protein -(hs-CRP; MD -1.35, 95% CI -2.41 to -0.28; 2 trials, 126 participants); and Newborns' hyperbilirubinemia (OR 0.33, 95% CI 0.13-0.80; 2 trials, 129 participants). CONCLUSIONS: Supplementation of GDM women with vitamin D may lead to an improvement in FPG, TC, LDL, HDL, hs-CRP serum levels as well as in newborns' hyperbilirubinemia.

Effect of hippotherapy simulator on pain, disability and range of motion of the spinal column in subjects with mechanical low back pain: A randomized single-blind clinical trial.

BACKGROUND: Hippotherapy is a form of therapeutic exercise for conservative treatment of lumbar spine segmental instability and/or hypomobility in subjects with low back pain (LBP). OBJECTIVE: The current study evaluates the effects of a hippotherapy simulator on pain, disability, and range of motion (ROM) of the spinal column in subjects with mechanical LBP. METHODS: In a randomized clinical trial, 80 subjects were randomly assigned to either the control or intervention groups. All subjects underwent routine physiotherapy. In addition, the intervention group underwent hippotherapy with a hippotherapy simulator for 15 sessions, each lasting 15 minutes. Pain, disability, and ROM of the lumbar spinal column of the subjects were measured in the first and last physiotherapy sessions respectively. RESULTS: Improvement in pain intensity was higher in the hippotherapy simulator group over the first eight days of treatment (Hippotherapy vs. Control Point changes: Day 12: p= 0.010; after treatment: p= 0.005). The hippotherapy simulator group had significantly higher improvement in disability score in comparison to the control group (p< 0.001); mean changes in the modified Schober test were not significant (p= 0.423). CONCLUSION: The hippotherapy simulator decreased pain and disability in subjects with LBP; however, no additional improvement in lumbar spine ROM was observed.

Effect of probiotic supplements in women with gestational diabetes mellitus on inflammation and oxidative stress biomarkers: a randomized clinical trial.

BACKGROUND AND OBJECTIVES: Very little is known about the use of probiotics among pregnant women with gestational diabetes mellitus (GDM) especially its effect on oxidative stress and inflammatory indices. The aim of present study was to measure the effect of a probiotic supplement capsule on inflammation and oxidative stress biomarkers in women with newly-diagnosed GDM. METHODS AND STUDY DESIGN: 64 pregnant women with GDM were enrolled in a double-blind placebo controlled randomized clinical trial in the spring and summer of 2014. They were randomly assigned to receive either a probiotic containing four bacterial strains of Lactobacillus acidophilus LA-5, Bifidobacterium BB-12, Streptococcus Thermophilus STY-31 and Lactobacillus delbrueckii bulgaricus LBY-27 or placebo capsule for 8 consecutive weeks. Blood samples were taken pre- and post-treatment and serum indices of inflammation and oxidative stress were assayed. The measured mean response scales were then analyzed using mixed effects model. All statistical analysis was performed using Statistical Package for Social Sciences (SPSS) software (version 16). RESULTS: Serum high-sensitivity C-reactive protein and tumor necrosis factor-α levels improved in the probiotic group to a statistically significant level over the placebo group. Serum interleukin-6 levels decreased in both groups after intervention; however, neither within group nor between group differences interleukin-6 serum levels was statistically significant. Malondialdehyde, glutathione reductase and erythrocyte glutathione peroxidase levels improved significantly with the use of probiotics when compared with the placebo. CONCLUSIONS: The probiotic supplement containing L.acidophilus LA- 5, Bifidobacterium BB- 12, S.thermophilus STY-31 and L.delbrueckii bulgaricus LBY-2 appears to improve several inflammation and oxidative stress biomarkers in women with GDM.

Nutrition Therapy in Managing Pregnant Women With Gestational Diabetes Mellitus: A Literature Review.

Objective: Gestational diabetes mellitus is the most common metabolic and endocrine perinatal complication and is a growing health problem worldwide. Considering the fetal programming and its contribution as one of the evolutionary origins of human diseases, it is very important to improve the glucose metabolism in pregnant women, determination of other nutrients, preventing excessive accumulation of fetal fats, emphasis on weight loss measures before pregnancy, dietary intake with low-fat healthy food and prevention of abundant weight loss. In this paper, we have provided a brief review on dietary intake and dietary interventions in GDM from the perspective of nutrition science attending the physiopathology and etiology of the disease. Materials and methods: Electronic search for English and Persian articles has been perform in databases, including Google Scholar, PubMed ,Scopus, Cochrane central ,Science direct, ISC, SID, Magiran, Iran Medex, and Med Libby key words: gestational diabetes, gestational diabetes mellitus, nutrition, macronutrient, micronutrient, Diabetes. All available articles (cross-sectional, descriptive-analytic, and clinical studies with desirable design and review quality studies were used. Reference books including Krause's Food and the Nutrition Care, The Williams Obstetrics editions of the 14th (2017) and the 24th edition (2014) were also reviewed. Results: Nutrition therapy and physical activity are the initial treatment of GDM. Proper and flexible methods of nutrition therapy that successfully regulate maternal glycaemia while improving expected fetal growth have extensive concepts. Meanwhile, dietary supplements with proven beneficial effects can play an important role in improving deficiencies and improving the metabolic profile of patients. Conclusion: Nutritional management is the main treatment for gestational diabetes mellitus and overweight/obesity is the principal contest in patient counseling and interventions during pregnancy. Despite extensive researches carried out, this field is an active research area and requires more clinical research to minimize maternal and fetal complications.