scholarly journals Effects of a Multispecies Probiotic Mixture on Glycemic Control and Inflammatory Status in Women with Gestational Diabetes: A Randomized Controlled Clinical Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-8 ◽  
Author(s):  
Sadegh Jafarnejad ◽  
Sadaf Saremi ◽  
Farzan Jafarnejad ◽  
Arman Arab
Keyword(s):  
Glycemic Control ◽  
Gestational Diabetes ◽  
Inflammatory Markers ◽  
Glycosylated Hemoglobin ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Model Assessment ◽  
Insulin Levels ◽  
Inflammatory Status

Objective. This trial aims to examine the effects of a Probiotic Mixture (VSL#3) on glycemic status and inflammatory markers, in women with GDM.Materials and Methods.Over a period of 8 weeks, 82 women with gestational diabetes were randomly assigned to either an intervention group (n=41) which were given VSL#3 capsule or to a control group which were given placebo capsule (n=41). Fasting plasma glucose, homeostatic model assessment of insulin resistance, glycosylated hemoglobin, high-sensitivity C-reactive protein, tumor necrosis factor-α, interleukin-6, Interferon gamma, and interleukin-10 were measured before and after the intervention.Results.After 8 wk of supplementation FPG, HbA1c, HOMA-IR, and insulin levels remained unchanged in the probiotic and placebo groups. The comparison between the two groups showed no significant differences with FPG and HbA1c, but there were significant differences in insulin levels and HOMA-IR (16.6±5.9;3.7±1.5, resp.). Unlike the levels of IFN-g (19.21±16.6), there was a significant decrease in levels of IL-6 (3.81±0.7), TNF-α(3.10±1.1), and hs-CRP (4927.4±924.6). No significant increase was observed in IL-10 (3.11±5.7) in the intervention group as compared with the control group.Conclusions.In women with GDM, supplementation with probiotics (VSL#3) may help to modulate some inflammatory markers and may have benefits on glycemic control.

scholarly journals The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Zahra Barati ◽  
Mina Iravani ◽  
Majid Karandish ◽  
Mohammad Hosein Haghighizadeh ◽  
Sara Masihi
Keyword(s):  
Clinical Trial ◽  
Blood Glucose ◽  
Gestational Diabetes ◽  
Fasting Blood Glucose ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Standard Diet ◽  
Oat Bran ◽  
Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

scholarly journals The effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes: A clinical trial

F1000Research ◽  
2018 ◽  
Vol 7 ◽  
pp. 282 ◽  
Author(s):  
Mehrafza Gharachourlo ◽  
Zohreh Mahmoodi ◽  
Mahnaz Akbari Kamrani ◽  
Maryam Tehranizadeh ◽  
Kourosh Kabir
Keyword(s):  
Clinical Trial ◽  
Health Literacy ◽  
Gestational Diabetes ◽  
Intervention Group ◽  
Trial Registration ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Unhealthy Lifestyle ◽  
Pregnancy Care ◽  
The Mean

Background: Gestational diabetes is a common pregnancy disorder that affects the mother’s and neonate’s health. The present study was conducted to investigate the effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes. The present randomized controlled clinical trial was conducted in 2017 using a parallel design. The subjects included 84 eligible women presenting to Alborz and Kamali Hospitals, Karaj, Iran. Methods: Convenience sampling was first used to select the subjects. They were then assigned to an intervention or control group based on randomized blocks of four. Both groups attended counselling sessions. The mothers in the intervention group attended six sessions of counselling with a health literacy approach in addition to counselling on routine pregnancy care. The control group attended counselling sessions on safe pregnancy care and received a training package containing all the subjects discussed in the intervention group. The Lifestyle Questionnaire and the Iranian Health Literacy Questionnaire were completed by the mothers at the beginning and at the end of the sessions as well as three weeks after the sessions. The data obtained were analyzed in SPSS-19. Results: According to the study findings, the scores of lifestyle (P=0.8) and health literacy (P=0.423) showed no significant differences between the intervention and control groups before the intervention. Significant differences were, however, observed in the mean scores of lifestyle and health literacy between the two groups immediately and three weeks after the intervention. Comparing the means showed a higher increase in the mean scores in the intervention group (P<0.001). Conclusions: Providing counselling services by midwives can significantly help modify mothers’ unhealthy lifestyle choices and increase their health literacy; therefore, reducing maternal and neonatal consequences, especially in high-risk pregnancies. Trial registration number: IRCT2017021427728N3 Trial registry: Iranian Registry of Clinical Trials Trial registration date: 5th April 2017

scholarly journals Effect of Raja Yoga Meditation on the Distress and Anxiety Levels of Women with Breast Cancer

Religions ◽  
2021 ◽  
Vol 12 (8) ◽  
pp. 590
Author(s):  
Raquel Vilanova Araújo ◽  
Ana Fátima Carvalho Fernandes ◽  
Regina Célia Vilanova Campelo ◽  
Renan Alves Silva ◽  
Inez Sampaio Nery
Keyword(s):  
Breast Cancer ◽  
Intervention Group ◽  
Vital Signs ◽  
Educational Activity ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Specialized Center ◽  
Care Practices ◽  
Anxiety Depression ◽  
Yoga Meditation

Objective: To evaluate the effect of Raja yoga meditation on the level of distress and anxiety in women with breast cancer. Method: A randomized, controlled, clinical trial was carried out in a specialized center between February and December 2019. The patients in the intervention group (n = 25) participated in four group meditation sessions for one month, and the participants in the control group (n = 25) were exposed to an educational activity for the same period and frequency. Cohen’s d was used to evaluate the effect size. Results: A significant reduction in the level of distress and anxiety was found in the intervention group (p < 0.001). The effect of meditation was average in reducing distress, anxiety, depression, and vital signs. There was also an average effect on the increase in saturation of peripheral oxygen (SPO2). Conclusion: The practice of meditation reduced distress and anxiety more effectively than the usual care practices.

scholarly journals The effect of vitamin D and magnesium supplementation on the mental health status of attention-deficit hyperactive children: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mostafa Hemamy ◽  
Naseh Pahlavani ◽  
Alireza Amanollahi ◽  
Sheikh Mohammed Shriful Islam ◽  
Jenna McVicar ◽  
...  
Keyword(s):  
Mental Health ◽  
Vitamin D ◽  
Attention Deficit ◽  
Controlled Trial ◽  
Neurodevelopmental Disorder ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Magnesium Supplementation ◽  
Children With Adhd

Abstract Background Attention-Deficit / Hyperactivity Disorder (ADHD) is a neurodevelopmental disorder, characterized by varying severity in attention deficit and hyperactivity. Studies have shown deficiencies in the serum level of magnesium and vitamin D in people with ADHD. The aim of this study is to determine the effect of vitamin D and magnesium supplementation on mental health in children with ADHD. Methods We conducted a randomized, double blind, placebo-controlled clinical trial of 66 children with ADHD. Participants were randomly allocated to receive both vitamin D (50,000 IU/week) plus magnesium (6 mg/kg/day) supplements (n = 33) or placebos (n = 33) for 8-weeks. Strengths and difficulties questionnaire was used to evaluate children’s mental health at baseline and the end of the study. Results After eight weeks of intervention, the serum levels of 25-hydroxy-vitamin D3 and magnesium increased significantly in the intervention group compared with the control group. Also, children receiving vitamin D plus magnesium showed a significant reduction in emotional problems (p = 0.001), conduct problems (p = 0.002), peer problems (p = 0.001), prosocial score (p = 0.007), total difficulties (p = 0.001), externalizing score (p = 0.001), and internalizing score (p = 0.001) compared with children treated with the placebo. Conclusion Vitamin D (50,000 IU/week) and magnesium (6 mg/kg/day) co-supplementation for a duration of 8-weeks could improve the behavioral function and mental health of children with ADHD. However, further well-designed studies with a larger sample size are needed. Trial registration IRCT2016030326886N1.

A randomized trial of the effect of peer education on the sexual quality of life in patients with myocardial infarction

2020 ◽  
Vol 17 (3) ◽  
Author(s):  
Ali Abbasi ◽  
Hossein Ebrahimi ◽  
Hossein Bagheri ◽  
Mohammad Hasan Basirinezhad ◽  
Seyedmohammad Mirhosseini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Myocardial Infarction ◽  
Health Care Professionals ◽  
Peer Education ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Sexual Quality Of Life ◽  
Significant Difference

AbstractBackgroundOne of the factors associated with readmission is inappropriate sexual activity after myocardial infarction (MI). This study aimed to assess the effect of peer education on the sexual quality of life (SQOL) in patients with MI.MethodsIn this randomized controlled clinical trial, 70 patients with MI meeting the inclusion criteria were assigned to experimental or control groups using block randomization. Peer education for the intervention group was provided on the third day after MI. Education sessions lasted from 90 to 120 minutes. Data were collected using demographic, sexual quality of life-female (SQOL-F), and sexual quality of life-male (SQOL-M) questionnaires during the fourth week after MI.ResultsThere was no significant difference between the two groups before the intervention in terms of demographic and SQOL. The mean of SQOL in the peer education group was significantly higher than the control group at the 4-week follow-up.ConclusionsAccording to the results, using peer education is recommended for the sexual health care professionals.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

A Randomized Study to Assess the Impact of Pharmacist Counseling of Employer-Based Health Plan Beneficiaries With Diabetes

2011 ◽  
Vol 25 (2) ◽  
pp. 169-179 ◽  
Author(s):  
Dale F. Kraemer ◽  
Wayne A. Kradjan ◽  
Theresa M. Bianco ◽  
Judi A. Low
Keyword(s):  
Diabetes Management ◽  
Statistical Significance ◽  
Glycosylated Hemoglobin ◽  
Randomized Study ◽  
Intervention Group ◽  
Control Group ◽  
Counseling Intervention ◽  
Care Plans ◽  
Pharmacist Counseling ◽  
The Impact

Objective: To assess the impact of pharmacist counseling on empowering people with diabetes to better self-care. Introduction: Community-based pharmacists can play a key role in educating and empowering people in such programs. Methods: A randomized trial compared the effects of pharmacist counseling (intervention group) with printed materials (control group) in diabetic beneficiaries of several employer-based health care plans. All participants also received waiver of out-of-pocket expenses for diabetic-related medications and supplies. Clinical, humanistic, and claim outcomes were evaluated at baseline and at 1 year follow-up. Results: Sixty-seven beneficiaries participated in this study. The 0.50% decrease from baseline in glycosylated hemoglobin (A1c) was statistically significant ( P = .0008) in the intervention group and the difference between the groups approached statistical significance ( P = .076). Beneficiaries in both groups had greater claim costs for diabetic-related medications and supplies during the study year. Both groups also improved in ability to manage their diabetes with the counseling group showing a significantly better understanding of diabetes ( P = .0024). Conclusion: There was a trend toward improvement in A1c in patients counseled by pharmacist with an increased utilization of diabetes-related medications and supplies. Counseling also improved diabetes knowledge and empowered patients to better diabetes management.

scholarly journals The Effects of Tocotrienol-Rich Vitamin E (Tocovid) on Diabetic Neuropathy: A Phase II Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 1522
Author(s):  
Yeek Tat Ng ◽  
Sonia Chew Wen Phang ◽  
Gerald Chen Jie Tan ◽  
En Yng Ng ◽  
Nevein Philip Botross Henien ◽  
...  
Keyword(s):  
Vitamin E ◽  
Nerve Conduction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serum Biomarkers ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Diabetic Patients ◽  
Chronic Hyperglycemia ◽  
Conduction Velocities

Chronic hyperglycemia increases oxidative stress, activates inflammatory pathways and reduces nerve growth factor (NGF) among diabetic patients, which contribute to development of diabetic peripheral neuropathy (DPN). Tocotrienol-Rich Vitamin E (Tocovid) possesses potent antioxidant and anti-inflammatory properties which are postulated to target these pathogeneses in order to ameliorate DPN. This study aims to evaluate the effects of Tocovid on nerve conduction parameters and serum biomarkers among diabetic patients. This multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial was conducted on 80 eligible participants. The intervention group (n = 39) was randomly allocated to receive 200 mg of Tocovid twice a day, and the control group (n = 41) received placebo twice a day. At the end of eight weeks, the nerve conduction parameters, as assessed by nerve conduction study, as well as serum biomarkers (NGF, malondialdehyde, vascular cell adhesion molecule 1, tumor necrosis factor receptor 1 and thromboxane B2) were compared between the two groups. Compared to placebo, Tocovid significantly improves the nerve conduction velocities of all nerves (+1.25 m/s, interquartile range [IQR] 3.35, p < 0.001, median nerve; +1.60 m/s, IQR 1.80, p < 0.001, sural nerve; +0.75 m/s, IQR 2.25, p < 0.001, tibial nerve). Meanwhile, the levels of serum NGF were significantly higher in the Tocovid group as compared to placebo at eight weeks post-intervention. Participants receiving Tocovid illustrated highly significant improvement in terms of nerve conduction velocities for all nerves tested after eight weeks of supplementation. In addition, Tocovid supplementation elevated the levels of serum NGF, in which its increase is postulated to reflect enhanced neuronal functions. This novel finding suggests that Tocovid could be a disease-modifying agent targeting serum NGF to improve nerve conduction velocities.

scholarly journals Curcumin nanomicelle versus curcumin improves lipid profile, stress oxidative factors and inflammatory markers in patients undergoing coronary elective angioplasty; A Randomized Clinical Trial

2019 ◽  
Author(s):  
Bijan Helli ◽  
Hadis Gerami ◽  
Maria Kavianpour ◽  
Habib Heybar ◽  
Seyed Kianoosh Hosseini ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lipid Profile ◽  
Inflammatory Markers ◽  
Interleukin 1 ◽  
Stress Index ◽  
Inflammatory Factors ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Stress Oxidative

Abstract Background: Curcumin exhibited antioxidant and anti-inflammatory effects. The aim of this study, assess and compare curcumin and nano- curcumin effects on lipid profile, oxidative stress index and inflammatory factors of heart patients.Methods: This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted on 90 patients undergoing coronary elective angioplasty. Patients were randomly divided into 3 groups. The first group received a 500 mg capsule of curcumin daily. The second group received an 80 mg capsule of nano- curcumin daily. The placebo group also received capsules similar to curcumin for 8 weeks. Lipid profile, stress oxidative factors and inflammatory markers measured in baseline and end of the investigation.Results: At the end of study, statistically significant changes was seen in the total cholesterol (TC), triglyceride (TG) and low density lipoprotein (LDL) in the intervention groups to the control group (p<0.05). These changes in the nano-curcumin group were greater than the curcumin group. Curcumin and nano-curcumin supplementation also caused a statistically significant improvement in plasma levels of total antioxidant capacity (TAC), malondialdehyde (MDA), Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), high-sensitivity C-reactive protein (hs-CRP), Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) in comparison to the placebo (p<0.05).Conclusion: Complementary therapy of cardiovascular patients with curcumin and nano-curcumin supplements, could improve lipid profile, stress oxidative index and, inflammatory factors. The effects of curcumin on nano formula may be better for cardiac patients due to high bioavailability. However, further investigation is suggested in this regard.

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