Effects of sesame, canola and sesame-canola oils on body weight and composition in adults with type 2 diabetes mellitus: a randomized, triple-blind, cross-over clinical trial.

BACKGROUND: Recent investigations have proposed that sesame and canola oils might affect body fat distribution. The present study aimed to examine the effects of sesame, canola and sesame-canola (a blend of sesame and canola oils) oils on body weight and composition in adults with type 2 diabetes mellitus in the context of a randomized, triple-blind, three-way, cross-over clinical trial. RESULTS: Eligible participants were randomized to replace their regular dietary oil with sesame oil (SO), canola oil (CO) and sesame-canola oil (SCO) (with 40% SO and 60% CO). Treatment periods lasted 9 weeks and were separated by 4-week wash-out periods. Body weight and composition were measured at the beginning, in the middle and at the end of each intervention phase. In total, 93 participants completed the study. After adjustment for confounders, within-period changes were observed following SO and CO intake for body weight (0.34 ± 0.16 kg and 0.33 ± 0.17 kg) and visceral fat (0.13 ± 0.06% and 0.13 ± 0.05%, P < 0.05), respectively. Body mass index was increased within SO intake (0.13 ± 0.05 kg m-2 , P = 0.031). All of the treatment oils resulted in reduced waist circumference and index of central obesity (P < 0.05). A significant difference in change values was observed for visceral fat between SCO (-0.14 ± 0.07%) and SO (0.12 ± 0.08%) treatment periods in females (P = 0.02). CONCLUSION: Sesame and canola oils might lead to a modest favorable body fat redistribution by reducing central adiposity, particularly in females; however, the changes were of little clinical importance. © 2021 Society of Chemical Industry.

The effect of canola, sesame and sesame-canola oils on body fat and composition in adults: a triple-blind, three-way randomised cross-over clinical trial.

The present study aimed to examine the effect of replacing edible oils with sesame oil (SO), canola oil (CO) and sesame-canola oil (SCO) on body weight and composition in adults. Adults without any chronic diseases (n = 77) were entered a 4-week run-in period and then were randomised to receive SO, CO and SCO for their household use in 9-week intervention periods (separated by 4-week washout intervals). Anthropometric measurements, as well as body composition markers, were assessed at baseline, middle and after each intervention period. In total, 73 participants completed the study. Although significant time effects were seen for waist and hip circumference, waist-to-hip ratio, central obesity index, body adiposity index, muscle mass and body fat percent (ptime<.05), the treatment and treatment × time effects were not significant (p>.05). The present clinical trial revealed that CO, SO and SCO might not differently affect body fat and composition. Trial registration code: IRCT2016091312571N6 (http://en.irct.ir/trial/12622).

Effects of synbiotic supplementation on gut microbiome, serum level of TNF-α, and expression of microRNA-126 and microRNA-146a in patients with type 2 diabetes mellitus: study protocol for a double-blind controlled randomized clinical trial.

BACKGROUND: The dramatic increase in the prevalence of type 2 diabetes mellitus (T2DM) is a global major challenge to health. Circulating microRNAs have been suggested as promising biomarkers for different disorders such as diabetes. Imbalances in the gut microbiome have been revealed to contribute to the progression of multiple diseases including T2DM. Recently, the consumption of probiotics and synbiotics in the treatment of various diseases has shown a substantial growth. The anti-diabetes and anti-inflammatory effects of synbiotics have been indicated, which may be due to their beneficial effects on the gut microbiome. However, further research is needed to assess the effects of synbiotics on the microbiota and their impacts on expression of microRNAs relating to T2DM. Thus, we will aim to assess the effects of synbiotics on microbiota, serum level of tumor necrosis factor-α (TNF-α), and expression of microRNA-126 and microRNA-146a in patients with T2DM. METHODS: Seventy-two patients with T2DM will be recruited in this double-blind randomized parallel placebo-controlled clinical trial. After block matching based on age and sex, participants will be randomly assigned to receive 1000 mg/day synbiotic (Familact) or placebo for 12 weeks. The microRNA-126 and microRNA-146a expression levels will be measured by real-time polymerase chain reaction and serum TNF-α level will be assessed by enzyme-linked immunosorbent assay kit at the beginning and at the end of the study. Determination of the gut microbiota will be done by quantitative polymerase chain reaction methods at baseline and at the end of the trial. Biochemical assessments (glycemic and lipid profiles) will also be conducted at onset and end of the study. DISCUSSION: This is the first randomized controlled trial that will determine the effect of synbiotic supplementation on the gut microbiota and its probable impacts on serum levels of TNF-α and expression of related microRNAs in patients with T2DM. TRIAL REGISTRATION: Iranian Registry of Clinical Trials: IRCT20180624040228N2. Registered on 27 March 2019. http://www.irct.ir/trial/38371.

The effect of resveratrol supplementation on serum levels of asymmetric de-methyl-arginine and paraoxonase 1 activity in patients with type 2 diabetes: A randomized, double-blind controlled trial.

The present study sought to investigate the effect of micronized resveratrol supplementation on serum levels of asymmetric de-methyl-arginine (ADMA) and paraoxonase-1 (PON1) activity in patients with type 2 diabetes (T2D). In this double-blinded randomized trial, 76 patients with T2D were recruited. Participants were randomly assigned to consume 1,000 mg resveratrol or placebo capsules (methylcellulose) per day, for 8 weeks. Serum levels of ADMA and PON1 enzyme activity were measured at the beginning and end of the intervention using the enzyme-linked immunosorbent assay method. In total, 71 participants completed the study. Our results showed that resveratrol significantly decreased serum levels of ADMA (-0.16 ± 0.11, p < .001) and improved PON1 enzyme activity (15.39 ± 13.99, p < .001) compared with placebo, after adjusting for confounding factors (age, sex, and baseline body mass index). Our findings suggest that 8-week resveratrol supplementation may produce beneficial effects on serum levels of ADMA and PON1 enzyme activity in patients with T2DM. However, further research is needed to confirm the veracity of these results.

The Effect of Resveratrol Supplementation on Cardio-Metabolic Risk Factors in Patients with Type 2 Diabetes: A Randomized, Double-Blind Controlled Trial.

The aim of the present randomized controlled trial was to evaluate the effect of a micronized resveratrol supplement on glycemic status, lipid profile, and body composition in patients with type 2 diabetes mellitus (T2DM). A total of 71 overweight patients with T2DM (body mass index ranged 25-30) were randomly assigned to receive 1000 mg/day trans-resveratrol or placebo (methyl cellulose) for 8 weeks. Anthropometric indices and biochemical indices including lipid and glycemic profile were measured before and after the intervention. In adjusted model (age, sex, and baseline body mass index), resveratrol decreased fasting blood sugar (-7.97±13.6 mg/dL, p=0.05) and increased high density lipoprotein (3.62±8.75 mg/dL, p=0.01) levels compared with placebo. Moreover, the mean difference in insulin levels reached significance (-0.97±1.91, µIU/mL, p= 0.02). However, no significant differences were observed for anthropometric measures. It was found that 8-week resveratrol supplementation produced useful effects on some cardio-metabolic parameters in patients with T2DM. More studies are needed to confirm these findings.

Dose vitamin D supplementations improve peripheral diabetic neuropathy? A before-after clinical trial.

OBJECTIVE: Peripheral neuropathy is a common complication of diabetes mellitus. This study was set to assess the effect of vitamin D supplementation on peripheral neuropathy in patients with type 2 diabetes (T2DM). MATERIALS AND METHODS: This study was a quasi-experimental trial in Yazd diabetic research center. Sixty T2DM subjects (30-65 years old) with painful diabetic neuropathy enrolled in this study from March 2017 till April 2018. Patients received weekly 50000 IU of vitamin D3 for 12 weeks orally. Evaluation of diabetic neuropathy was performed by using Michigan Neuropathy Screening Instrument (MNSI) before and after trial. Also fasting plasma glucose, HbA1c, calcium and vitamin D checked before and after the trial. SPSS version 20 software was used for statistical analysis. P ≤ 0.05 was considered to be statistically significant. RESULTS: Among 60 T2DM patients, 58 completed the study. Most of them (53.4%) were male. At the end of study, HbA1c, vitamin D, MNSI (both questionnaire and physical examination) improved that is statistically significant (p-value: <0.001). CONCLUSION: Oral supplementation of vitamin D 3 (50,000 IU) once weekly for 12 weeks was associated with improvement in the serum level of vitamin D and significant decrease in the symptoms and sign of diabetic neuropathy. So serum vitamin D level should be checked in persons with diabetic neuropathy and low levels of it should be corrected in order to reducing neuropathy severity.

Effects of an Herbal Combination on Glycemic Control and Lipid Profile in Diabetic Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

The present study was conducted to explore the efficacy and safety of a herbal combination in the treatment of women with hyperlipidemic type 2 diabetes. The herbal combination capsule (600 mg) contained Terminalia chebula fruit extract (200 mg), Commiphora mukul (200 mg), and Commiphora myrrha oleo-gum-resin (200 mg), and the placebo capsule contained 600 mg toast powder. The patients in one group took the herbal combination and those in the other group took placebo capsules 3 times a day for 3 months. In the herbal combination-treated patients, the fasting blood glucose, total cholesterol, and low-density lipoprotein cholesterol levels were decreased and hidh-density lipoprotein cholesterol levels was increased significantly at the endpoint compared with the placebo and baseline. Other blood parameters such as glycosylated hemoglobin, triglyceride, blood urea nitrogen, creatinine, SGOT, and SGPT levels were not significantly changed after 3 months in both groups. In conclusion, the herbal combination improves glycemic control and lipid profile in women with hyperlipidemic type 2 diabetes without any adverse events.

Effects of bee propolis supplementation on glycemic control, lipid profile and insulin resistance indices in patients with type 2 diabetes: a randomized, double-blind clinical trial.

BACKGROUND: Propolis, a natural resinous substance made by bees from material extracted from plants, flowers and bee's wax, has shown great therapeutic effects and been widely used in food and drug industries. Recently, some researchers have studied the effect of this substance in the treatment of diabetes. OBJECTIVE: The purpose of this trial was to determine the effect of bee propolis on glycemic control, serum lipid profile and insulin resistance indices in patients with type 2 diabetes (T2D). DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: This randomized clinical trial involved 66 patients with T2D, which were randomly divided into two groups of intervention (IG) and placebo (PG). IG received 300 mg three times a day for a total of 900 mg/d of propolis pills, while PG received similar pills, lacking propolis, on the same schedule for 12 weeks. MAIN OUTCOME MEASURES: Fasting blood glucose (FBG), hemoglobin A1c (HbA1c), total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride (TG), serum insulin and insulin resistance indices were the main outcome measures. RESULTS: The mean change in FBG between the IG ((17.76 ± 27.72) mg/dL decrease) and the PG ((6.48 ± 42.77) mg/dL increase) was significantly different (P = 0.01). Change in mean HbA1c had a similar pattern to FBG. The mean change in TC between the IG ((5.16 ± 43.80) mg/dL increase) and the PG ((28.9 ± 27.4) mg/dL increase) was also significantly different (P = 0.01), showing the protective role of propolis against the increase in TC. The change in mean LDL was similar to mean TC. There was no significant difference in other lipids or insulin resistance indices between the two groups. CONCLUSION: Based on this study, the daily intake of 900 mg of bee propolis supplement for 12 weeks results in improvement of glycemic and some serum lipid levels in patients with T2D. TRIAL REGISTRATION: This study is registered on the website of Iranian Ministry of Health (www.irct.ir) with proprietary code of IRCT2014080218659N1.