The effect of acarbose on inflammatory cytokines and adipokines in adults: a systematic review and meta-analysis of randomized clinical trials.

BACKGROUND: Although a large number of trials have observed an anti-inflammatory property of acarbose, the currently available research remains controversial regarding its beneficial health effects. Hence, the purpose of this study was to examine the effect of acarbose on inflammatory cytokines and adipokines in adults. METHODS: PubMed, Web of Science, and Scopus were systematically searched until April 2023 using relevant keywords. The mean difference (MD) of any effect was calculated using a random-effects model. Weighted mean difference (WMD) and 95% confidence intervals (CIs) were calculated via the random-effects model. RESULTS: The current meta-analysis of data comprised a total of 19 RCTs. Meta-analysis showed that acarbose significantly decreased tumor necrosis factor-alpha (TNF-α) (weighted mean difference [WMD]) = - 4.16 pg/ml, 95% confidence interval (CI) - 6.58, - 1.74; P = 0.001) while increasing adiponectin (WMD = 0.79 ng/ml, 95% CI 0.02, 1.55; P = 0.044). However, the effects of acarbose on TNF-α concentrations were observed in studies with intervention doses ≥ 300 mg/d (WMD = - 4.09; 95% CI - 7.00, - 1.18; P = 0.006), and the adiponectin concentrations were significantly higher (WMD = 1.03 ng/ml, 95%CI 0.19, 1.87; P = 0.016) in studies in which the duration of intervention was less than 24 weeks. No significant effect was seen for C-reactive protein (CRP; P = 0.134), interleukin-6 (IL-6; P = 0.204), and leptin (P = 0.576). CONCLUSION: Acarbose had beneficial effects on reducing inflammation and increasing adiponectin. In this way, it may prevent the development of chronic diseases related to inflammation. However, more studies are needed.

The interaction between MALAT1 and TUG1 with dietary fatty acid quality indices on visceral adiposity index and body adiposity index.

We aimed to investigate the interaction between the transcript levels of taurine-upregulated gene 1 (TUG1) and metastasis-associated lung adenocarcinoma transcript 1 (MALAT1) and the Cholesterol-Saturated Fat Index (CSI) in relation to the visceral adiposity index (VAI) and body adiposity index (BAI). This cross-sectional study involved 346 women classified as obese and overweight, aged between 18 and 48 years. Dietary intake and the quality of dietary fat were assessed using a validated and reliable 147-item semi-quantitative food frequency questionnaire, with the Cholesterol-Saturated Fat Index (CSI) used as an indicator. Transcription levels of MALAT1 and TUG1 were evaluated through real-time polymerase chain reaction following the criteria outlined in the Minimum Information for Publication of Quantitative standards. Serum profiles were measured using standard protocols. We observed a positive association between transcription level of MALAT1 and VAI in both crude (ß = 3.646, 95% CI 1.950-5.341, p < 0.001) and adjusted (ß = 8.338, 95% CI 6.110-10.566, p < 0.001) models. Furthermore, after adjusting for confounders, a significant positive interaction was noted between MALAT1 expression and CSI on BAI (ß: 0.130, 95% CI 0.019, 0.240, p = 0.022), with a marginal positive interaction observed on VAI (ß: 0.718, 95% CI - 0.028, 1.463, p = 0.059). It seems that there may be a positive interaction between MALAT1 transcription level and CSI on VAI and BAI among overweight and obese women. However, no associations were seen between TUG1 mRNA level and the above-mentioned outcomes. Further functional studies are still required to elucidate this concept.

Examining the effectiveness of home-based cardiac rehabilitation programs for heart failure patients with reduced ejection fraction: a critical review.

BACKGROUND: Heart failure (HF) is the most common cardiovascular reason for hospital admission, particularly among patients older than 60 years old. Heart failure with reduced ejection fraction (HFrEF) comprises approximately 50% of all heart failure cases. Home-based cardiac rehabilitation (HBCR) is an alternative option to enhance the participation rate in cardiac rehabilitation (CR) interventions for patients who are not able to attend center-based cardiac rehabilitation (CBCR). The purpose of this review is to clarify the extent to which present studies of HBCR align with the core components defined by both the European Society of Cardiology (ESC) and the British Association for Cardiac Prevention and Rehabilitation (BACPR). METHODS: A critical review was conducted through four databases, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews, to identify randomized controlled trials up until June 2022. We scrutinized the commonalities between BACPR and ESC and developed a list of standards. The risk of bias was assessed using the RoB 2 tool. RESULTS: Among the 87 papers selected for full-text screening, 11 studies met the inclusion criteria. Six papers possessed a high proportion of fidelity to essential standards, four studies had a medium alliance, and one intervention had a low level of alliance. CONCLUSION: Overall, the majority of included studies had medium to high alignment with standards and core components. However, a need for more attention to long-term strategy as an important standard is revealed. Rapid identification and initial assessment are the most met standards; however, lifestyle risk factor management and long-term outcomes were recognized as the least met standards.

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine (FAKHRAVAC®) in healthy adults aged 18-55 years: Randomized, double-blind, placebo-controlled, phase I clinical trial.

Background: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity. Methods and findings: In this double-blind, placebo-controlled, phase I trial, we randomly assigned 135 healthy adults between 18 and 55 to receive vaccine strengths of 5 or 10 µg/dose or placebo (adjuvant only) in 0-14 or 0-21 schedules. This trial was conducted in a single center in a community setting. The safety outcomes in this study were reactogenicity, local and systemic adverse reactions, abnormal laboratory findings, and Medically Attended Adverse Events (MAAE). Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels.The most frequent local adverse reaction was tenderness (28.9%), and the most frequent systemic adverse reaction was headache (9.6%). All adverse reactions were mild, occurred at a similar incidence in all six groups, and were resolved within a few days. In the 10-µg/dose vaccine group, the geometric mean ratio for neutralizing antibody titers at two weeks after the second injection compared to the placebo group was 9.03 (95% CI: 3.89-20.95) in the 0-14 schedule and 11.77 (95% CI: 2.77-49.94) in the 0-21 schedule. The corresponding figures for the 5-µg/dose group were 2.74 (1.2-6.28) and 5.2 (1.63-16.55). The highest seroconversion rate (four-fold increase) was related to the 10-µg/dose group (71% and 67% in the 0-14 and 0-21 schedules, respectively). Conclusions: FAKHRAVAC® is safe and induces a strong humoral immune response to the SARS-CoV-2 virus at 10-µg/dose vaccine strength in adults aged 18-55. This vaccine strength was used for further assessment in the phase II trial.Trial registrationThis study is registered with https://www.irct.ir; IRCT20210206050259N1.

The effect of acarbose on lipid profiles in adults: a systematic review and meta-analysis of randomized clinical trials.

PURPOSE: Dyslipidemia, characterized by elevated levels of triglycerides (TG), low-density lipoprotein (LDL), total cholesterol (TC), and reduced levels of high-density lipoprotein (HDL), is a major risk factor for cardiovascular diseases (CVD). Several studies have shown the potential of acarbose in improving serum lipid markers. However, there have been conflicting results on the topic in adults. Therefore, a comprehensive systematic review and meta-analysis was conducted to assess the impact of acarbose on lipid profiles. METHODS: The random-effects approach was used to combine the data, and the results were provided as weighted mean difference (WMD) with 95% confidence intervals (CI). RESULTS: Our meta-analysis included a total of 74 studies with a combined sample size of 7046 participants. The results of the analysis showed that acarbose resulted in a reduction in levels of TG (WMD = - 13.43 mg/dl, 95% CI: - 19.20, - 7.67; P < 0.001) and TC (WMD = - 1.93 mg/dl, 95% CI: - 3.71, - 0.15; P = 0.033), but did not affect other lipid markers. When conducting a nonlinear dose-response analysis, we found that acarbose was associated with an increase in levels of HDL (coefficients = 0.50, P = 0.012), with the highest increase observed at a dosage of 400 mg/d. Furthermore, our findings suggested a non-linear relationship between the duration of the intervention and TC (coefficients = - 18.00, P = 0.032), with a decline observed after 50 weeks of treatment. CONCLUSION: The findings of this study suggest that acarbose can reduce serum levels of TG and TC. However, no significant effects were observed on LDL or HDL levels.

The association between dietary pattern and visceral adiposity index, triglyceride-glucose index, inflammation, and body composition among Iranian overweight and obese women.

The aim of the present study was to investigate the association between dietary patterns, derived through latent class analysis (LCA), with visceral adiposity index (VAI), Triglyceride-Glucose Index (TyG), inflammation biomarkers, and body composition in overweight and obese Iranian women. For this cross-sectional study, dietary exposure was assessed using a validated 147-item semi-quantitative food frequency questionnaire (FFQ). Dietary patterns were derived through LCA. Binary logistic was performed to test the associations of dietary patterns with VAI, TyG, inflammation biomarkers, and body composition. Health centers in Tehran, Iran. 376 obese and overweight women, aged > 18 years. Two dietary patterns were identified using LCA modeling: healthy and unhealthy. Women in the unhealthy class were characterized by higher consumption of fast food, sweetened beverages, grains, unhealthy oils, butter and margarine, and snacks. Compared with the healthy class, the unhealthy class was associated with an increased risk of higher fasting blood sugar (FBS) (OR = 6.07; 95% CI: 1.33-27.74, P value = 0.02), c-reactive protein (CRP) (OR = 1.72; 95% CI: 1.05-2.80; P value = 0.02), and lower fat free mass index (FFMI) (OR = 0.56; 95% CI: 0.35-0.88, P value = 0.01), after adjusting for confounders. We found that adherence to an unhealthy dietary pattern was associated with decreased FFMI and increased FBS and CRP using LCA, but not with the rest of the variables. Further studies should be conducted to confirm the veracity of these findings.

Interactions Between Genetic Risk Score and Healthy Plant Diet Index on Cardiometabolic Risk Factors Among Obese and Overweight Women.

People with higher genetic predisposition to obesity are more susceptible to cardiovascular diseases (CVDs) and healthy plant-based foods may be associated with reduced risks of obesity and other metabolic markers. We investigated whether healthy plant-foods-rich dietary patterns might have inverse associations with cardiometabolic risk factors in participants at genetically elevated risk of obesity. For this cross-sectional study, 377 obese and overweight women were chosen from health centers in Tehran, Iran. We calculated a healthy plant-based diet index (h-PDI) in which healthy plant foods received positive scores, and unhealthy plant and animal foods received reversed scores. A genetic risk score (GRS) was developed based on 3 polymorphisms. The interaction between GRS and h-PDI on cardiometabolic traits was analyzed using a generalized linear model (GLM). We found significant interactions between GRS and h-PDI on body mass index (BMI) (p = 0.02), body fat mass (p = 0.04), and waist circumference (p = 0.056). There were significant gene-diet interactions for healthful plant-derived diets and BMI-GRS on high-sensitivity C-reactive protein (p = 0.03), aspartate aminotransferase (p = 0.04), alanine transaminase (p = 0.05), insulin (p = 0.04), and plasminogen activator inhibitor 1 (p = 0.002). Adherence to h-PDI was more strongly related to decreased levels of the aforementioned markers among participants in the second or top tertile of GRS than those with low GRS. These results highlight that following a plant-based dietary pattern considering genetics appears to be a protective factor against the risks of cardiometabolic abnormalities.

Investigation of the interaction between Genetic Risk Score (GRS) and fatty acid quality indices on mental health among overweight and obese women.

BACKGROUND & AIMS: Mental disorders are associated with dietary fatty acids and genome-wide association studies have found multiple risk loci robustly related to depression, anxiety, and stress. The aim of this study is to investigate the interaction of genetic risk score (GRS) and dietary fat quality indices on mental health. METHODS: This cross-sectional study included 279 overweight and obese women for N6/N3 ratio and 378 overweight and obese women for CSI aged 18-68 years. Using reliable and verified standard protocols, body composition, anthropometric indices, blood pressure, physical activity, and dietary fat quality were measured. Serum samples were used to determine biochemical tests. A genetic risk score (GRS) was calculated using the risk alleles of the three SNPs. A generalized linear model (GLM) was applied to assess the interactions between GRS and fat quality indices. Mental health was evaluated using Depression Anxiety Stress Scales (DASS-21). RESULTS: The mean (± SD) age and BMI of our participants were 36.48 (8.45) and 30.73 (3.72) kg/m2 respectively. There was a marginally significant mean difference among tertiles of the CSI in terms of stress (P = 0.051), DASS-21 (P = 0.078) in the crude model. After adjusting for age, energy intake, physical activity and BMI in model 1, there was a positive interaction between GRS and T3 of N6/N3 ratio on anxiety (ß = 0.91, CI = 0.08,1.75, P = 0.031), depression (ß = 1.05, CI = 0.06,2.04, P = 0.037), DASS-21 (ß = 2.22, CI= -0.31,4.75, P = 0.086). CONCLUSION: Our findings indicate that higher ratio of N-6 to N-3 considering genetics were predictive of mental disorder in our population.

The effects of hesperidin supplementation on cardiovascular risk factors in adults: a systematic review and dose-response meta-analysis.

Hesperidin is a naturally occurring bioactive compound that may have an impact on cardiovascular disease risks, but the evidence is not conclusive. To investigate further, this study aimed to explore the effects of hesperidin supplementation on cardiovascular risk factors in adults. A comprehensive search was conducted up to August 2022 using relevant keywords in databases such as Scopus, PubMed, Embase, Cochrane Library, and ISI Web of Science for all randomized controlled trials (RCTs). The results showed that hesperidin supplementation had a significant effect on reducing serum triglyceride (TG), total cholesterol (TC), low-density cholesterol (LDL), tumor necrosis factor-alpha (TNF-α), and systolic blood pressure (SBP), whereas weight was increased. However, no significant effect was observed on high-density cholesterol (HDL), waist circumference (WC), fasting blood glucose (FBG), insulin, homeostatic model assessment for insulin resistance (HOMA-IR), C-reactive protein (CRP), interleukin-6 (IL-6), body mass index (BMI), and diastolic blood pressure (DBP). The study also found that an effective dosage of hesperidin supplementation was around 1,000 mg/d, and a more effective duration of supplementation was more than eight weeks to decrease insulin levels. Furthermore, the duration of intervention of more than six weeks was effective in decreasing FBG levels.

Safety and efficacy of the FAKHRAVAC compared with BBIBP-Corv2 against SARS-CoV-2 in adults: a non-inferiority multi-center trial.

BACKGROUND: We compared Fakhravac and BBIBP-Corv2 vaccines in a phase III trial. METHOD: We conducted a multicenter, parallel-group, active-control, non-inferiority clinical trial with pragmatic considerations assessing the safety and efficacy of Fakhravac and BBIBP-Corv2 vaccines. We started with two randomized double-blind arms and added two non-randomized open-label arms (based on participant preference) because of slow recruitment. The adult population received 0.5 ml (10 µg per dose) intramuscular injections of Fakhravac or BBIBP-Corv-2 vaccines 21 days apart. The primary outcome was the occurrence of PCR-positive symptomatic Covid-19 disease 14 days or more after the second injection. A 10% non-inferiority margin to the reported 72.8% efficacy of BBIBP-Corv2 was assumed. Cox proportional hazard modeling was used to estimate hazard ratios and their 95% confidence intervals. RESULT: We enrolled 24,056 adults in four groups (randomized-Fakhravac: 824, randomized-BBIBP-Corv2: 832; Non-randomized-Fakhravac: 19,429, Non-randomized-BBIBP-Corv2: 2971). All observed local and systemic adverse reactions were generally self-limited and resolved completely. We observed similar Serious Adverse Event (SAE) rates in the BBIBP-Corv2 (2.57, 95% CI 1.33-4.49) and Fakhravac (2.25, 95% CI 1.72-2.89) groups; none of which were related to the vaccines received. We recorded 9815 Medically Attendant Adverse Events (MAAE), 736 of which were categorized as somehow related. The rate of related MAAE in the Fakhravac was similar to the BBIBP-Corv2 groups (0.31 and 0.26 per 1000 person-day) in the randomized and considerably higher (0.24 and 0.07 per 1000 person-day) in the non-randomized arms. We observed 129 (35% of the 365 required by target sample size) events of PCR + symptomatic Covid-19 during four months of active follow-up in the randomized arm, demonstrating that those receiving the Fakhravac vaccine were significantly less likely (HR = 0.69; 95% CI 0.49-0.98) to be diagnosed with PCR + symptomatic Covid-19 compared with those receiving BBIBP-Corv2 vaccine. After adjusting for type I error using the O'Brien Fleming method, the Fakhravac vaccine was non-inferior to the BBIBP-Corv2 (assuming a 10% non-inferiority margin to the reported 72.8% BBIBP-Corv2 vaccine efficacy; HR < 1.35) (One-way test: HR = 0.66; 99.8% CI 0.38-1.15). In the non-randomized arm, the results were inconclusive (HR = 1.23; 95% CI 0.96-1.61). We observed 5 cases of hospitalized Covid-19 in the randomized arm, none of which occurred in the Fakhravac vaccine group. Those receiving the Fakhravac vaccine were four times less likely to go to the hospital because of a Covid-19 diagnosis (HR = 0.24; 95% CI 0.10-0.60). The vaccine efficacy of the Fakhravac vaccine is estimated to be 81.5% (95% CI 81-82.4%). CONCLUSION: Fakhravac inactivated SARS-CoV-2 vaccine has comparable safety and efficacy to the BBIBP-Corv2 vaccine. Trial registration This study was registered with the Iranian Registry of Clinical Trials ( www.irct.ir : IRCT20210206050259N3).

Investigation the interaction of dietary fat quality indices and the MC4R gene in metabolically healthy and unhealthy overweight and obese women.

Obesity has become a common global problem. Some obese people can be metabolically healthy. Gene-environment interaction can be important in this context. This study aimed to assess the interaction between dietary fat quality indices and the Melanocortin 4 receptor (MC4R) gene in metabolically healthy and unhealthy overweight and obese women. This cross-sectional study was conducted on 279 women with overweight and obesity. The definition of metabolically healthy and unhealthy phenotypes was done according to Karelis criteria. Dietary assessment was done using a 147-item validated semi-quantitative food frequency questionnaire and dietary fat quality was assessed by cholesterol-saturated fat index (CSI) and the ratio of omega-6/omega-3 (N6/N3) essential fatty acids. MC4R was genotyped by polymerase chain reaction-restriction fragment length polymorphism technique. A generalized linear model was used to evaluate the interaction between dietary fat quality indices and the MC4R gene in both crude and adjusted models. Study subjects with higher ratio of N6/N3 had higher homeostatic model assessment for insulin resistance (HOMA IR) index (P = 0.03) and other variables showed no difference according to the tertile of CSI and N6/N3. Participants with the C allele of MC4R rs17782313 had lower height (P < 0.001) and higher HOMA index (P = 0.01). We found that the CC genotype of MC4R interacts with the N6/N3 ratio on the metabolically unhealthy phenotype in the crude model (ß = 9.94, CI 2.49-17.39, P = 0.009) and even after adjustment for all confounders (ß = 9.002, CI 1.15-16.85, P = 0.02, ß = - 12.12, CI 2.79-21.46, P = 0.01). The data of this study can justify one inconsistency observed in society, regarding dietary recommendations about metabolic health status. Those with CC genotype, are more likely to have an unhealthy phenotype with an increase in N6/N3 as one fat quality indices than those who do not have CC genotype. We found the interaction of dietary fat quality indices such as N6/N3 and the MC4R gene in metabolically unhealthy overweight and obese women.

The association between cholesterol/saturated fat index (CSI) and quality of sleep, and circadian rhythm among overweight and obese women: a cross-sectional study.

BACKGROUND: The decline in sleep quality is one of the main public health problems affecting the global population. Some studies have shown that a high-fat diet may be linked to changes in circadian rhythm and sleep quality. The cholesterol/saturated fatty acid index (CSI) determines the amount of cholesterol and saturated fatty acid (SFA) in people's dietary patterns and can affect the quality of sleep and circadian rhythm. However, to date, no studies have investigated the effect of this index on these two variables. Therefore, our aim was to investigate the relationship between CSI on circadian rhythm and sleep quality in obese and overweight women. METHOD: This cross-sectional study included 378 adult women who were obese or overweight. Using accepted techniques, anthropometric measurements, blood pressure readings, and biochemical variables were evaluated. A validated and trustworthy semi-quantitative food frequency questionnaire (FFQ 147 items) was used to gauge dietary intake. The CSI was measured to find out how much cholesterol and saturated fats were in the diet. Additionally, to assess circadian rhythm and sleep quality, respectively, the valid morning-evening questionnaire (MEQ) and Pittsburgh sleep quality index (PSQI) questionnaires were utilized. RESULT: The results of the multinomial logistic regression model of our analysis showed that a significant association was observed between circadian rhythm status with CSI score, and participants with one higher unit of CSI had a 7.3% more chance of being in the eveningness group than being in morningness category in the crude model (OR: 1.07; 95% CI 1.00, 1.14; P = 0.026). This association remains marginally significant when adjusting for age, energy intake, BMI, job status, thyroid, and smoking status (OR = 1.08; 95% CI 1.00, 1.16; P = 0.051). The binary logistic regression model showed that after controlling for potentially confounding variables, there was no significant association between sleep quality with CSI score, however, those with one higher unit of CSI had 1.6% more chance of having sleep problems (OR: 1.01; 95% CI 0.96, 1.06; P = 0.503). CONCLUSION: Our results indicated a direct marginally significant association between CSI with evening type in overweight and obese women. Future studies are needed to clarify the precise link between circadian rhythm and sleep behavior with fatty acid quality index.

Oxime Esters: Flexible Building Blocks for Heterocycle Formation.

Oxime esters as the applicable building blocks, internal oxidizing agents, and directing groups in the synthesis of -, S-, and O-containing heterocycle scaffolds have gained great attention in the last decade. This review provides an overview of recent advances in the cyclization of oxime esters with various functional group reagents under transition metal and transition metal-free catalyzed conditions. Moreover, the mechanistic aspects of these protocols are explained in detail.

Comparing the Effects of Differential and Visuo-Motor Training on Functional Performance, Biomechanical, and Psychological Factors in Athletes after ACL Reconstruction: A Randomized Controlled Trial.

Variation during practice is widely accepted to be advantageous for motor learning and is, therefore, a valuable strategy to effectively reduce high-risk landing mechanics and prevent primary anterior cruciate ligament (ACL) injury. Few attempts have examined the specific effects of variable training in athletes who have undergone ACL reconstruction. Thereby, it is still unclear to what extent the variations in different sensor areas lead to different effects. Accordingly, we compared the effects of versatile movement variations (DL) with variations of movements with emphasis on disrupting visual information (VMT) in athletes who had undergone ACL reconstruction. Forty-five interceptive sports athletes after ACL reconstruction were randomly allocated to a DL group (n = 15), VT group (n = 15), or control group (n = 15). The primary outcome was functional performance (Triple Hop Test). The secondary outcomes included dynamic balance (Star Excursion Balance Test (SEBT)), biomechanics during single-leg drop-landing task hip flexion (HF), knee flexion (KF), ankle dorsiflexion (AD), knee valgus (KV), and vertical ground reaction force (VGRF), and kinesiophobia (Tampa Scale of Kinesiophobia (TSK)) assessed before and after the 8 weeks of interventions. Data were analyzed by means of 3 × 2 repeated measures ANOVA followed by post hoc comparison (Bonferroni) at the significance level of p ≤ 0.05. Significant group × time interaction effects, main effect of time, and main effect of group were found for the triple hop test and all eight directions, SEBT, HF, KF, AD, KV, VGRF, and TSK. There was no significant main effect of group in the HF and triple hop test. Additionally, significant differences in the triple hop test and the seven directions of SEBT, HF, KF, KV, VGRF, and TSK were found between the control group and the DL and VMT groups. Between group differences in AD and the medial direction of SEBT were not significant. Additionally, there were no significant differences between VMT and the control group in the triple hop test and HF variables. Both motor learning (DL and VMT) programs improved outcomes in patients after ACL reconstruction. The findings suggest that DL and VMT training programs lead to comparable improvements in rehabilitation.

Phase II randomized, double blind, placebo controlled, clinical trial of safety and immunogenicity of an inactivated SARS-CoV-2 vaccine FAKHRAVAC in adults aged 18-70 years.

BACKGROUND: The FAKHRAVAC®, an inactivated SARS-CoV-2 vaccine, was assessed for safety and immunogenicity in a phase II trial. METHODS: We did a phase II, single-centered, randomized, double-blind, placebo-controlled clinical trial of the FAKHRAVAC inactivated SARS-CoV-2 vaccine on adults aged 18 to 70. The two parallel groups received two intramuscular injections of either a 10-µg vaccine or a placebo at 2-week intervals. The participants' immunogenicity responses and the occurrence of solicited and unsolicited adverse events were compared over the study period of up to 6 months. Immunogenicity outcomes include serum neutralizing antibody activity and specific IgG antibody levels. RESULTS: Five hundred eligible participants were randomly (1:1) assigned to vaccine or placebo groups. The median age of the participants was 36 years, and 75% were male. The most frequent local adverse reaction was tenderness (21.29% after the first dose and 8.52% after the second dose), and the most frequent systemic adverse reaction was headache (11.24% after the first dose and 8.94% after the second dose). Neutralizing antibody titers two and four weeks after the second injection in the vaccine group showed about 3 and 6 times increase compared to the placebo group (GMR = 2.69, 95% CI 2.32-3.12, N:309) and (GMR = 5.51, 95% CI 3.94-8.35, N:285). A four-fold increase in the neutralizing antibody titer was seen in 69.6% and 73.4% of the participants in the vaccine group two and four weeks after the second dose, respectively. Specific ELIZA antibody response against a combination of S1 and RBD antigens 4 weeks after the second injection increased more than three times in the vaccine compared to the placebo group (GMR = 3.34, 95% CI 2.5-4.47, N:142). CONCLUSIONS: FAKHRAVAC® is safe and induces a significant humoral immune response to the SARS-CoV-2 virus at 10-µg antigen dose in adults aged 18-70. A phase III trial is needed to assess the clinical efficacy. TRIAL REGISTRATION: Trial Registry Number: Ref., IRCT20210206050259N2 ( http://irct.ir ; registered on 08/06/2021).

The association of dietary acid load (DAL) with estimated skeletal muscle mass and bone mineral content: a cross-sectional study.

BACKGROUND & AIMS: Dietary patterns that promote mild metabolic acidosis may have a negative effect on bone and muscle, and a high dietary acid load (DAL) may be detrimental to skeletal muscle mass and bone mineral content. However, the association between skeletal muscle mass and bone mineral content with dietary acid load has not been consistently reported in previous studies. The objective of the study was to evaluate the association of potential renal net acid load (PRAL) and net endogenous acid production (NEAP) with bone mineral content and skeletal muscle mass in pre-menopause women with overweight or obesity in Iran. METHOD: Three hundred and ninety women with a body mass index (BMI) of 25 were included in this cross-sectional study. We used a validated 147-item semi-quantitative food frequency questionnaire (FFQ) for evaluating the dietary intake. Based on the dietary data, potential renal net acid load (PRAL) and net endogenous acid production (NEAP) were calculated. Muscle mass and bone mineral content were estimated by a bioelectrical impedance analyzer (BIA). RESULTS: After controlling for potential confounders, we discovered a significant linear relationship between PRAL (ß = -0.027, 95%CI = -0.049 to -0.004, P = 0.02) and NEAP (ß = -0.05, 95%CI = -0.097 to -0.003, P = 0.03) and skeletal muscle mass index. However, there was no significant difference between SMM and BMC across PRAL and NEAP tertiles. CONCLUSION: PRAL and NEAP were found to be inversely related to skeletal muscle mass index among overweight/obese women. Further research is required to establish whether this relationship is important for musculoskeletal health in these populations.

The association between glycemic index and glycemic load and quality of life among overweight and obese women: a cross-sectional study.

BACKGROUND: The association between different dietary approaches and quality of life (QoL) has been well-demonstrated in previous research. However, the relationship between glycemic index (GI) and glycemic load (GL) with different dimensions of QoL has not been established. Therefore, we aimed to investigate the relationship between GI and GL with QoL in overweight and obese women. METHODS: Two hundred seventy-six overweight and obese women (body mass index (BMI) ≥ 30 kg/m2), aged 18-64 years old, were included in this cross-sectional study. The amount of dietary intake and GI and GL indexes were established using a valid and reliable Food Frequency Questionnaire (FFQ) containing 147 items. Body composition (using bioimpedance analysis), anthropometrics, and physical activity were assessed. Insulin resistance (HOMA-IR) and hs-CRP were also measured, whilst QoL was measured using the SF-36 (short-form-36), self-administered, questionnaire. RESULT: Analyses were performed using multivariable linear regression, considering a wide range of confounding variables, such as age, physical activity, BMI, education, job, smoking, and marriage. We found a significant negative association between glycemic load and quality of life (ß = -0.07, 95%CI = -0.13_ -0.01, p = 0.01). No significant associations were observed between glycemic index and quality of life (ß = -0.03, 95%CI = -0.81_ 0.75, p = 0.93). CONCLUSION: We observed a significant negative association between QoL and GL, but not GI, among overweight and obese women in Iran. Our results need to be confirmed with further well-designed and adequately powered studies that control for clinical confounders.

The association between healthy beverage index and quality of life among overweight and obese women: a cross-sectional study.

BACKGROUND: Although several studies have evaluated the association between patterns of beverage consumption with different components of quality of life separately, the findings are controversial. In addition, none have examined all components of quality of life together in relation to patterns of beverage consumption. Therefore, this study was conducted to identify the association between healthy beverage index (HBI) and quality of life among overweight and obese women. METHODS: For this cross-sectional study, 210 obese and overweight women were recruited from health centers in Tehran, Iran. Using reliable and verified standard protocols, data on beverage intake, socio-demographic, physical activity, and anthropometric variables were assessed. Based on past studies, the predetermined HBI was estimated. Serum samples were used to determine biochemical characteristics, and quality of life was assessed using SF-36 questionnaires. RESULTS: There was a significant association between total QoL score with T2 tertile of HBI in the adjusted model (ß: 13.11, 95% CI: 1.52, 24.69, p-value = 0.027). General health had a significant negative association with T2 (ß: -5.83; 95% CI: - 11.48, - 0.18; p-value = 0.043) and T3 (ß: -6.20; 95% CI: - 12.37, - 0.03; p-value = 0.049). Women with greater adherence to the HBI had a higher physical functioning score, and there was a significant upward trend from the second to the third tertile (7.74 vs 0.62) (-trend = 0.036). There was a significant positive association between mental health with T3 of HBI (ß: 4.26; 95% CI: 1.51, 5.98; p-value = 0.015) and a significant increasing trend was observed with increasing tertiles (P-trend = 0.045). CONCLUSION: In conclusion, there is a significant association between total QoL score, and its components, with HBI among overweight and obese women. However, additional well-designed studies are needed to confirm these findings.

The association between healthy beverage index and sarcopenic obesity among women with overweight and obesity: a cross-sectional study.

INTRODUCTION: Sarcopenic obesity is related to changes in body composition, loss of muscle mass, and raised adipose tissue. Beverage patterns are effective with changes in health status. Therefore, the aim of this study was to investigate the association between sarcopenic obesity (SO) and the healthy beverage index (HBI) in women with overweight and obesity. METHODS: This cross-sectional study conducted on 210 overweight and obese (BMI ≥25 kg/m2) women aged 18-56 years. The measurement of skeletal muscle mass (SMM) and fat mass (FM) done by bioelectric impedance analyzer (BIA) (Inbody Co., Seoul, Korea) based on guidelines. The two lowest quintiles SMM and the two highest quintiles FM and body mass index (BMI) ≥30 are considered sarcopenic obesity in women. A validated and reliable semi-quantitative food-frequency questionnaire (FFQ) was used to evaluate the beverage dietary data. and RFS and NRFS was calculated. Biochemical assessments were quantified by standard approaches, and physical activity were evaluated by international physical activity questionnaire (IPAQ). RESULT: In this cross-sectional study, 210 overweight and obese females took part (18-56) years old). The studies were carried out using binary logistic regression. After controlling for a wide variety of confounding variables such as age, energy intake, physical activity, education, and economic status, we found a negative association between HBI and risk of SO (OR = 0.29, 95% CI = 0.35 to 1.01, P = 0.05). CONCLUSION: We observed that the odds of SO was reduced by 69% in participants with higher HBI score. More well-designed studies need to confirm our findings.

Association of low-carbohydrate diet score and carbohydrate quality with visceral adiposity and lipid accumulation product.

The present study examined the association between low-carbohydrate diet (LCD) score, glycemic index (GI), and glycemic load (GL) with visceral fat level (VFL) and lipid accumulation product (LAP). This cross-sectional study was conducted on 270 adults (118 men and 152 women) aged between 18-45 living in Tehran, Iran, between February 2017 and December 2018. Dietary intake was assessed using a validated semi-quantitative food frequency questionnaire (FFQ). Body composition were also assessed. We used analyses of covariance and binary logistic regression to explore associations after controlling for age, energy intake (model 1), education, smoking status, physical activity, occupation, marriage and metabolic diseases. There were no significant differences between tertiles of GI, GL and LCD for means of anthropometric measures, LAP and VFL index in men, while women in the highest tertile of GI and GL had significantly higher mean LAP in the crude model (P = 0·02) and model 1(P = 0·04), which disappeared after controlling for other confounders (P = 0·12). Moreover, the OR and CIs for having high LAP and VFL was not associated with dietary GI, GL and LCD in crude and adjusted models. However, chance of high VFL reduced by 65% and 57% among women with high adherence to LCD score (OR = 0·35, 95% CI = 0·16-0·78, P = 0·01) and model 1 (OR = 0·43, 95% CI = 0·18-1, P = 0·05), respectively. However, this significant association disappeared after controlling for other confounders (P = 0·07). Overall, we found carbohydrate quality and LCD score are not associated with LAP and VFL index. However, gender-specific relationship should not be neglect and warrants further investigation.