Sex hormone-binding globulin may explain sex differences for glucose homeostasis and incidence of type 2 diabetes: the KORA study.

Research has indicated that sex hormone-binding globulin (SHBG) is associated with glucose homeostasis and may play a role in the etiology of type 2 diabetes (T2D). While it is unclear whether SHBG may mediate sex differences in glucose control and subsequently, incidence of T2D. We used observational data from the German population-based KORA F4 study (n = 1937, mean age: 54 years, 41% women) and its follow-up examination KORA FF4 (median follow-up 6.5 years, n = 1387). T2D was initially assessed by self-report and validated by contacting the physicians and/ or reviewing the medical charts. Mediation analyses were performed to assess the role of SHBG in mediating the association between sex (women vs. men) and glucose- and insulin-related traits (cross-sectional analysis) and incidence of T2D (longitudinal analysis). After adjustment for confounders, (model 1: adjusted for age; model 2: model 1 + smoking + alcohol consumption + physical activity), women had lower fasting glucose levels compared to men (ß = -4.94 (mg/dl), 95% CI: -5.77, -4.11). SHBG levels were significantly higher in women than in men (ß = 0.47 (nmol/l), 95% CI:0.42, 0.51). Serum SHBG may mediate the association between sex and fasting glucose levels with a proportion mediated (PM) of 30% (CI: 22-41%). Also, a potential mediatory role of SHBG was observed for sex differences in incidence of T2D (PM = 95% and 63% in models 1 and 2, respectively). Our novel findings suggest that SHBG may partially explain sex-differences in glucose control and T2D incidence.

Calcium Hydroxylapatite (CaHA) and Aesthetic Outcomes: A Systematic Review of Controlled Clinical Trials.

Background: This study aimed to systematically review and summarize the available controlled clinical trials on the effectiveness of calcium hydroxylapatite (CaHA) in terms of aesthetic outcomes, skin-aging-related outcomes, and patient/investigator satisfaction. Methods: We included controlled clinical trials involving at least 10 human adults that examined the effects of CaHA on aesthetic and skin-aging-related outcomes and satisfaction. Due to the high heterogeneity among the included studies, only a qualitative analysis is provided. Results: Out of 2935 relevant references, 13 studies were included, of which 8 studies focused on facial areas and 5 on dorsum of hand. CaHA injection was associated with enhancements in global aesthetic improvement scale, whether applied in facial regions or on the dorsum of hands. The findings suggested high patients' satisfaction following CaHA when applied to facial areas. Studies highlighted improvements in hand grading scales and a reduction in facial wrinkles. Conclusions: Current evidence suggests that CaHA injections improve aesthetic results, including facial areas, such as nasolabial folds and jawline, and hands, with high levels of satisfaction. Considering the methodological limitations and heterogeneous comparisons groups, additional controlled clinical trials would contribute to a better understanding of the applications and advantages offered by CaHA.

Skin regeneration-related mechanisms of Calcium Hydroxylapatite (CaHA): a systematic review.

Introduction: Calcium Hydroxylapatite (CaHA) is a common dermal filler used in aesthetic medicine for volumizing and contouring. Understanding mechanisms of actions of CaHA can help improve our understanding of its clinical applications. Methods: We performed a systematic review to summarize the skin-regeneration related mechanisms of CaHA. Five bibliographic databases were searched for English-language publications that evaluated CaHA in skin regeneration outcomes including neocollagenesis, cell proliferation and growth factors, angiogenesis, vascular dynamic and inflammatory markers, among others. Methodological rigor of included studies was assessed. Results: Of 2,935 identified citations, 12 studies were included for final analysis. Collagen production was reported by nine studies, cell proliferation by four, elastic fibers and/or elastin by four, and three studies on angiogenesis, while limited studies were available on the other outcomes. Six were clinical/observational studies. Only seven studies had a control group. Overall, studies showed CaHA resulted in increased cell proliferation, increased collagen production and angiogenesis, as well as in higher elastic fiber and elastin formation. Limited and inconclusive evidence was available on the other mechanisms. The majority of the studies had methodological limitations. Discussion: Current evidence is limited but indicates several mechanisms through which CaHA could lead to skin regeneration, volume enhancement, and contouring. Systematic review registration: https://doi.org/10.17605/OSF.IO/WY49V.

Prognostic models in COVID-19 infection that predict severity: a systematic review.

Current evidence on COVID-19 prognostic models is inconsistent and clinical applicability remains controversial. We performed a systematic review to summarize and critically appraise the available studies that have developed, assessed and/or validated prognostic models of COVID-19 predicting health outcomes. We searched six bibliographic databases to identify published articles that investigated univariable and multivariable prognostic models predicting adverse outcomes in adult COVID-19 patients, including intensive care unit (ICU) admission, intubation, high-flow nasal therapy (HFNT), extracorporeal membrane oxygenation (ECMO) and mortality. We identified and assessed 314 eligible articles from more than 40 countries, with 152 of these studies presenting mortality, 66 progression to severe or critical illness, 35 mortality and ICU admission combined, 17 ICU admission only, while the remaining 44 studies reported prediction models for mechanical ventilation (MV) or a combination of multiple outcomes. The sample size of included studies varied from 11 to 7,704,171 participants, with a mean age ranging from 18 to 93 years. There were 353 prognostic models investigated, with area under the curve (AUC) ranging from 0.44 to 0.99. A great proportion of studies (61.5%, 193 out of 314) performed internal or external validation or replication. In 312 (99.4%) studies, prognostic models were reported to be at high risk of bias due to uncertainties and challenges surrounding methodological rigor, sampling, handling of missing data, failure to deal with overfitting and heterogeneous definitions of COVID-19 and severity outcomes. While several clinical prognostic models for COVID-19 have been described in the literature, they are limited in generalizability and/or applicability due to deficiencies in addressing fundamental statistical and methodological concerns. Future large, multi-centric and well-designed prognostic prospective studies are needed to clarify remaining uncertainties.

Circulating lipoprotein (a) and all-cause and cause-specific mortality: a systematic review and dose-response meta-analysis.

AIMS: To investigate the association between circulating lipoprotein(a) (Lp(a)) and risk of all-cause and cause-specific mortality in the general population and in patients with chronic diseases, and to elucidate the dose-response relations. METHODS AND RESULTS: We searched literature to find prospective studies reporting adjusted risk estimates on the association of Lp(a) and mortality outcomes. Forty-three publications, reporting on 75 studies (957,253 participants), were included. The hazard ratios (HRs) and 95% confidence intervals (95%CI ) for the top versus bottom tertile of Lp(a) levels and risk of all-cause mortality were 1.09 (95%CI: 1.01-1.18, I2: 75.34%, n = 19) in the general population and 1.18 (95%CI: 1.04-1.34, I2: 52.5%, n = 12) in patients with cardiovascular diseases (CVD). The HRs for CVD mortality were 1.33 (95%CI: 1.11-1.58, I2: 82.8%, n = 31) in the general population, 1.25 (95%CI: 1.10-1.43, I2: 54.3%, n = 17) in patients with CVD and 2.53 (95%CI: 1.13-5.64, I2: 66%, n = 4) in patients with diabetes mellitus. Linear dose-response analyses revealed that each 50 mg/dL increase in Lp(a) levels was associated with 31% and 15% greater risk of CVD death in the general population and in patients with CVD. No non-linear dose-response association was observed between Lp(a) levels and risk of all-cause or CVD mortality in the general population or in patients with CVD (Pnonlinearity > 0.05). CONCLUSION: This study provides further evidence that higher Lp(a) levels are associated with higher risk of all-cause mortality and CVD-death in the general population and in patients with CVD. These findings support the ESC/EAS Guidelines that recommend Lp(a) should be measured at least once in each adult person's lifetime, since our study suggests those with higher Lp(a) might also have higher risk of mortality.

The effects of sesame, canola, and sesame-canola oils on cardiometabolic markers in patients with type 2 diabetes: a triple-blind three-way randomized crossover clinical trial.

AIMS: To compare the effects of replacing regular dietary oils intake with sesame (SO), canola (CO), and sesame-canola (SCO) oils (a novel blend), on cardiometabolic markers in adults with type 2 diabetes mellitus (T2DM), in a triple-blind, three-way, randomized, crossover clinical trial. METHODS: Participants were assigned to receive SO, CO, and SCO in three 9-week phases (4 weeks apart). Cardiometabolic makers (serum lipids, Apolipoprotein, cardiovascular risk scores, kidney markers, and blood pressure) were considered at the beginning and the end of intervention phases. RESULTS: Ninety-two, ninety-five, and ninety-five participants completed the SO, SCO, and CO periods, respectively. After CO consumption, serum Apo A-1 concentrations were significantly higher compared with the SCO period in the whole population (p < 0.05). A considerable reduction in visceral adiposity index values was seen in the CO compared with the SO period in males (p < 0.05). Serum high-density lipoprotein concentration was also significantly higher after the SO intake compared with SCO in females (p < 0.05). The between-period analysis showed a substantial reduction in diastolic blood pressure in the SCO period compared with the CO and SO periods and lower systolic blood pressure after SCO versus CO intake in males (p < 0.05). CONCLUSIONS: Canola oil might protect CVD through improving Apo A-1 levels in patients with T2DM (particularly in females) and visceral adiposity index in male patients. However, the blend oil might beneficially affect blood pressure in men. Future sex-specific studies might warrant the current findings. REGISTRY OF CLINICAL TRIALS: This trial was registered in the Iranian Registry of Clinical Trials (IRCT, registration ID: IRCT2016091312571N6).

Validity and Reproducibility of a Semiquantitative Multiple-Choice Food Frequency Questionnaire in Iranian Adults.

Previous multiple-choice food-based food frequency questionnaires (FFQs) were not validated against weighed dietary records (WDRs) in Iran. This study investigated the validity and reproducibility of a multiple-choice semi-quantitative food frequency questionnaire (SQ-FFQ) in adults living in central Iran. Patients with diabetes and their spouses were asked to complete 3 SQ-FFQs by interview, and nine 3-day WDRs, over 9 months. They provided 2 blood samples to assess serum calcium, magnesium, zinc, and vitamin C levels. The Pearson and intraclass correlation coefficients were calculated to assess reproducibility and validity. The degree of misclassification was explored using a contingency table of quartiles which compare the information between third FFQ and WDRs. The method of triads was incorporated to assess validity coefficients between estimated intakes using third FFQ, WDRs, and biochemical markers and assumed true intakes. A total of 180 participants aged 48.9 ± 8.4 years completed the study. Compared to WDRs, FFQs overestimated all nutrient intakes except for iron. The median intraclass correlation between FFQs was 0.56. The median de-attenuated, age, sex, and education adjusted partial correlation coefficients for validity were 0.17 and 0.26 for FFQ1-WDRs and FFQ3-WDRs, respectively. The FFQ3 validity coefficients for vitamin C, calcium, magnesium, and zinc were 0.13, 0.62, 0.89, and 0.66, respectively, using the triads method. The median exact agreement and complete disagreement between FFQ3 and WDRs were 33% and 6%, respectively. The SQ-FFQ seems to be an acceptable tool to assess the long-term dietary intake for future large-scale studies in this population.

The effect of sesame, canola, and sesame-canola oils on cardiometabolic risk factors in overweight adults: a three-way randomized triple-blind crossover clinical trial.

Limited data exist on the cardiometabolic effects of sesame oil compared with canola oil. In the present study, 77 overweight adults were randomized to replace their regularly consumed oils with canola (CO), sesame (SO), and sesame-canola oils (SCO, 40% SO, and 60% CO) in three 9-week phases. Blood pressure, visceral adiposity index, serum apo-proteins (APOs) and lipid profile, glycemic control markers, kidney markers, liver enzymes, and cardiovascular disease risk scores were assessed at baseline and endline. After adjustment for confounders, SO significantly reduced serum alkaline aminotransferase (ALT) compared to CO (p ≤ 0.05) in all participants, increased serum urea compared to SCO in males, and decreased serum alkaline phosphatase compared to other oils in males, and improved serum high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG) compared to SCO, and eGFR compared with CO in females (p ≤ 0.05). Canola oil significantly improved serum Apo A1 and APO B/A ratio compared with SO, in males (p ≤ 0.05). Sesame-canola oil significantly reduced serum urea compared to other oils in all participants (p ≤ 0.05). Sesame oil and SCO might beneficially affect serum ALT and urea, respectively. Intervention oils might have different cardiometabolic effects in each gender. Further studies are needed to confirm our results (Trial registration code: IRCT2016091312571N6).

Whole-diet interventions and cardiovascular risk factors in postmenopausal women: A systematic review of controlled clinical trials.

OBJECTIVES: Menopause is accompanied by many metabolic changes, increasing the risk of cardiometabolic diseases. The impact of diet, as a modifiable lifestyle factor, on cardiovascular health in general populations has been well established. The purpose of this systematic review is to summarize the evidence on the effects of whole diet on lipid profile, glycemic indices, and blood pressure in postmenopausal women. METHODS: Embase, Medline, Cochrane Central Register of Controlled Trials, and Google Scholar were searched from inception to February 2021. We included controlled clinical trials in postmenopausal women that assessed the effect of a whole-diet intervention on lipid profile, glycemic indices, and/or blood pressure. The risk of bias in individual studies was assessed using RoB 2 and ROBINS-I tools. SUMMARY OF EVIDENCE: Among 2,134 references, 21 trials met all eligibility criteria. Overall, results were heterogenuous and inconsistent. Compared to control diets, some studies showed that participants experienced improvements in total cholesterol (TC), low-density lipoprotein cholesterol (LDL), systolic blood pressure (SBP), fasting blood sugar (FBS), and apolipoprotein A (Apo-A) after following fat-modified diets, but some adverse effects on triglycerides (TG), very low-density lipoprotein cholesterol (VLDL), lipoprotein(a) (Lp(a)), and high-density lipoprotein cholesterol (HDL) concentrations were also observed. A limited number of trials found some effects of the Paleolithic, weight-loss, plant-based, or energy-restricted diets, or of following American Heart Association recommendations on TG, TC, HDL, insulin, FBS, or insulin resistance. CONCLUSION: Current evidence suggests that diet may affect levels of some lipid profile markers, glycemic indices, and blood pressure among postmenopausal women. However, due to the large heterogeneity in intervention diets, comparison groups, intervention durations, and population characteristics, findings are inconclusive. Further well-designed clinical trials are needed on dietary interventions to reduce cardiovascular risk in postmenopausal women.

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.

Double-counting of effect sizes and inappropriate exclusion of studies in "The influence of vitamin D supplementation on IGF-1 levels in humans: A systematic review and meta-analysis".

We read with interest the review by Kord-Varkaneh et al. which examined the effects of vitamin D supplementation on IGF-1 levels in humans. We believe that the article suffers from severe methodological faults and subsequently the conclusions are likely to be biased. Thus, the authors should address the mentioned limitations and update the analyses to provide robust and trustful estimates. We are concerned that without correction, the analyses may lead to erroneous findings and conclusions.

Canola oil compared with sesame and sesame-canola oil on glycaemic control and liver function in patients with type 2 diabetes: A three-way randomized triple-blind cross-over trial.

BACKGROUND: This study aimed to compare the effects of sesame (SO), canola (CO), and sesame-canola (SCO: a blend) oils on glycaemic control markers and liver function enzymes in adults with type 2 diabetes. METHODS: In this randomized, triple-blind, three-way, cross-over clinical trial, participants replaced their usual oil with the intervention oils for 9 weeks. Serum fasting blood sugar, fasting serum insulin (FSI), insulin resistance (HOMA2-IR), beta-cell function (HOMA2-%B), insulin sensitivity (HOMA2-%S), quantitative insulin sensitivity check index (QUICKI), as well as serum liver function enzymes were measured at baseline and end of intervention periods. RESULTS: Ninety-two participants completed all treatment periods. After adjusting for confounders, all treatment oils resulted in significant improvements in FSI and HOMA2-%S (p < 0.05). SO and SCO led to favourable changes in HOMA2-IR and QUICKI (p < 0.05). Following CO and SCO, there was a significant decrease in HOMA2-%B (p < 0.05). The sex-stratified analysis revealed that FSI and HOMA2-IR were decreased after SO compared to CO in males (p = 0.024). Serum gamma-glutamyltransferase (GGT) was significantly lower following SO compared to CO in females (p = 0.02), however, the difference in change values was not significant (p = 0.058). CONCLUSIONS: SO consumption appears to improve glycaemic control markers in males and serum GGT in females compared with CO in patients with type 2 diabetes (registration code: IRCT2016091312571N6).

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).

The effects of Canola oil on cardiovascular risk factors: A systematic review and meta-analysis with dose-response analysis of controlled clinical trials.

BACKGROUND AND AIMS: Canola oil (CO) is a plant-based oil with the potential to improve several cardiometabolic risk factors. We systematically reviewed controlled clinical trials investigating the effects of CO on lipid profiles, apo-lipoproteins, glycemic indices, inflammation, and blood pressure compared to other edible oils in adults. METHODS AND RESULTS: Online databases were searched for articles up to January 2020. Forty-two articles met the inclusion criteria. CO significantly reduced total cholesterol (TC, -0.27 mmol/l, n = 37), low-density lipoprotein cholesterol (LDL-C, -0.23 mmol/l, n = 35), LDL-C to high-density lipoprotein cholesterol ratio (LDL/HDL, -0.21, n = 10), TC/HDL (-0.13, n = 15), apolipoprotein B (Apo B, -0.03 g/l, n = 14), and Apo B/Apo A-1 (-0.02, n = 6) compared to other edible oils (P < 0.05). Compared to olive oil, CO decreased TC (-0.23 mmol/l, n = 9), LDL-C (-0.17 mmol/l, n = 9), LDL/HDL (-0.39, n = 2), and triglycerides in VLDL (VLDL-TG, -0.10 mmol/l, n = 2) (P < 0.05). Compared to sunflower oil, CO improved LDL-C (-0.14 mmol/l, n = 11), and LDL/HDL (-0.30, n = 3) (P < 0.05). In comparison with saturated fats, CO improved TC (-0.59 mmol/l, n = 11), TG (-0.08 mmol/l, n = 11), LDL-C (-0.49 mmol/l, n = 10), TC/HDL (-0.29, n = 5), and Apo B (-0.09 g/l, n = 4) (P < 0.05). Based on the nonlinear dose-response curve, replacing CO with ~15% of total caloric intake provided the greatest benefits. CONCLUSION: CO significantly improved different cardiometabolic risk factors compared to other edible oils. Further well-designed clinical trials are warranted to confirm the dose-response associations.

The combined effects of cholesteryl ester transfer protein (CETP) TaqIB gene polymorphism and canola, sesame and sesame-canola oils consumption on metabolic response in patients with diabetes and healthy people.

Introduction: Cholesteryl ester transfer protein (CETP) is a key regulating enzyme in the lipid metabolism pathway, and its gene polymorphism may be a candidate for modulating the metabolic responses to dietary intervention. We thus examined whether the effects of the CETP TaqIB polymorphism on metabolic profiles were modified by dietary plant oils. Methods: This is a retrospective analysis of data collected during a randomized triple-blind cross over trial. A total of 95 patients with type 2 diabetes and 73 non-diabetes individuals completed a 9-weekof the intake of sesame, canola and sesame-canola oils. Blood samples were collected at the beginning and at the end of each intervention period for biochemical analysis. Genotyping was done using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method. Results: In diabetes patients, B1B1 homozygotes of the CETP TaqIB polymorphism compared with B2 carriers (B1B2 + B2B2) had significantly lower diastolic blood pressure, apoB and apoB: apoA-1,and higher Lp(a) after the intake of sesame-canola oil, as well as lower insulin and HOMA-IR after the intake of sesame oil. There was also a significant effect of genotype on adjusted changes of apoB, apoB: apoA-1, insulin, HOMA-IR and QUICKI. A significant genotype-dietary oils combined effects were observed for diastolic blood pressure, and LDL: HDL, TC: HDL and TG: HDL ratios in diabetes patients. No independent or combined effects of dietary oils and genotypes on outcomes were found in healthy people. Conclusion: There was a modulatory effect of the CETP TaqIB polymorphism on some metabolic traits in response to plant oils in patients with diabetes. Taken together, the intake of sesame-canola and canola oils showed more favorable effects in diabetes patients with B1B1 genotype. Future investigations are needed to confirm these results.

Association of rs670 variant of APOA-1 gene with cardiometabolic markers after consuming sesame, canola and sesame-canola oils in adults with and without type 2 diabetes mellitus.

BACKGROUND & AIMS: The inter-individual variations of the metabolic markers in response to dietary interventions may be mediated by genetic factors. We examined whether the type of dietary oils can modulate the effects of -75G/A polymorphism in APOA-1 gene on cardiometabolic markers. METHODS: This study was a randomized, triple-blind, cross-over clinical trial. Participants with and without type 2 diabetes were randomly assigned to replace their regular oil with sesame oil, canola oil and sesame-canola oil for 9 weeks. Genotyping was conducted using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) method. RESULTS: Ninety-five diabetes patients and 73 healthy individuals completed the study protocol. In patients with type 2 diabetes, the A allele carriers experienced greater decrease in systolic blood pressure compared with GG homozygotes following sesame-canola oil intake. Serum levels of HDL-C and TG: HDL ratio was increased and decreased following canola oil intake in patients carrying the A allele rather than non-A allele carriers, respectively. More reductions for risk of cardiovascular diseases and mortality, except risk of stroke were found in the A allele carriers compared with GG homozygotes after intakes of canola and sesame-canola oils, but not sesame oil. There was also a significant genotype effect as well as genotype-dietary oil interactions on cardiovascular risk scores. In healthy individuals, a considerable decrease in visceral fat was accompanied by a significant increase in HDL-C levels in the A allele carriers compared with non-A allele carriers after sesame oil intake. CONCLUSION: Patients with diabetes carrying the A allele might benefit from canola and sesame-canola oils intakes, and healthy A allele carriers from sesame and sesame-canola oils intakes as well. Future clinical trials are recommended to warrant current findings.

The effect of canola oil compared with sesame and sesame-canola oil on cardio-metabolic biomarkers in patients with type 2 diabetes: Design and research protocol of a randomized, triple-blind, three-way, crossover clinical trial.

BACKGROUND: Both canola and sesame oils consumption have been associated with favorable effects on cardio-metabolic biomarkers. However, to the best of our knowledge, no study has compared their effects on cardiovascular risk factors. The present study aimed to assess the effect of canola, sesame, and sesame-canola oils consumption on cardio-metabolic biomarkers in patients with type 2 diabetes mellitus (T2DM). METHODS: This study was a randomized, triple-blind, three-way, crossover clinical trial. The study participants included 102 individuals with T2DM. Their spouses were also included in the study. The participants were entered into a 4-week run-in period. After that, their regular dietary oil was replaced with canola, sesame, or sesame-canola oils (a blend of sesame and canola oils) in three 9-week phases, which were separated by two 4-week washout periods (sunflower oil was consumed during the run-in and the washout periods). Dietary, physical activity, blood pressure, and anthropometric measurements were assessed at the beginning, in the middle (week 4-5), and at the end of each treatment phase. Blood samples were taken at the beginning and at the end of each phase. Serum, plasma, buffy coat, and whole blood samples were extracted and kept at -80 ºC for further analysis. Serum fasting blood sugar (FBS), triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) were selected as the primary outcomes. RESULTS: 102 participants with T2DM were randomly assigned to one of the 6 rolling methods. Through them, 93 individuals (91.2%) completely participated in all phases. CONCLUSION: The present study will provide an exceptional opportunity to examine the effect of canola, sesame, and sesame-canola oil on cardio-metabolic markers in adults with and without T2DM. This trial will also provide a good medium for the investigation of gene-dietary oils interaction in the future.