Changes in Fat Mass Index and Fat-Free Mass Index Vary Significantly by Age and Sex of the Patient, and by Type of Bariatric Surgery.

BACKGROUND: The loss of fat-free mass after rapid weight loss following bariatric surgery shows BMI is inadequate for reporting weight loss, emphasizing the need for a more accurate body composition metric. This study assessed changes in fat mass index (FMI), fat-free mass index (FFMI), and dietary intake over 6 months after one-anastomosis gastric bypass (OAGB), Roux-en-Y gastric bypass (RYGB), and sleeve gastrectomy (SG) across age and sex groups. MATERIALS AND METHODS: This prospective observational study included 151 bariatric surgery candidates. Data on demographics, anthropometric, body composition, and food intake data were collected before and 6 months after surgery. SPSS version 22 was used for analysis, employing ANOVA and t-tests to assess group differences. RESULTS: Younger patients (≤ 35 years) had higher percent total and excess weight loss (%TWL and %EWL) across all bariatric surgeries, and those undergoing SG experienced more favorable changes in fat-free mass (FFM) and visceral fat compared to other procedures (P = 0.002). Males had higher percent change in fat mass index (%∆ FMI) and visceral fat than females with OAGB and RYGB (P < 0.05). Women undergoing SG and RYGB had a more significant decrease in energy intake compared to OAGB (P < 0.001), and the ≤ 35 and 35-44 age groups demonstrated lower reductions in energy intake following OAGB. CONCLUSION: Age, sex, and surgery type significantly affect bariatric surgery outcomes. Younger patients achieved greater weight-related improvements, while men undergoing RYGB experienced more substantial fat mass changes than women.

Investigating the role of the built environment, socio-economic status, and lifestyle factors in the prevalence of chronic diseases in Mashhad: PLS-SEM model.

Background: Chronic diseases remain a significant contributor to both mortality and disability in our modern world. Physical inactivity and an unhealthy diet are recognized as significant behavioral risk factors for chronic diseases, which can be influenced by the built environment and socio-economic status (SES). This study aims to investigate the relationship between the built environment, SES, and lifestyle factors with chronic diseases. Methods: The current study was conducted in Mashhad's Persian cohort, which included employees from Mashhad University of Medical Sciences (MUMS). In the study, 5,357 participants from the cohort were included. To assess the state of the built environment in Mashhad, a Geographic Information System (GIS) map was created for the city and participants in the Persian Mashhad study. Food intake and physical exercise were used to assess lifestyle. A food frequency questionnaire (FFQ) was used to assess food intake. To assess food intake, the diet quality index was computed. To assess the link between variables, the structural model was created in accordance with the study's objectives, and partial least square structural equation modeling (PLS-SEM) was utilized. Results: The chronic diseases were positively associated with male sex (p < 0.001), married (p < 0.001), and higher age (p < 0.001). The chronic diseases were negatively associated with larger family size (p < 0.05), higher SES (p < 0.001), and higher diet quality index (DQI) (p < 0.001). No significant relationship was found between chronic disease and physical activity. Conclusion: Food intake and socioeconomic status have a direct impact on the prevalence of chronic diseases. It seems that in order to reduce the prevalence of chronic diseases, increasing economic access, reducing the class gap and increasing literacy and awareness should be emphasized, and in the next step, emphasis should be placed on the built environment.

Navigating sarcopenia in COVID-19 patients and survivors: Understanding the long-term consequences, transitioning from hospital to community with mechanisms and interventions for future preparedness.

The coronavirus disease 2019 (COVID-19) pandemic has caused widespread devastation, with millions of confirmed cases and deaths worldwide. Although there were efforts made to develop treatments and vaccines for COVID-19, the coexistence of sarcopenia, a muscle disorder, has been largely overlooked. It is while new variants of this disease (eg, BA.2.86) are challenging the current protocols. Sarcopenia is associated with increased mortality and disability, and shares common mechanisms with COVID-19, such as inflammation, hormonal changes, and malnutrition. This can worsen the effects of both conditions. Furthermore, survived patients with COVID-19 who have elevated risk, as well as aging, which increases the process of sarcopenia. Therefore, addressing sarcopenia in patients with COVID-19 and surviving individuals can be crucial for improving outcomes and preventing long-term disability. During hospital stays, assessing sarcopenia through indicators like muscle wasting and malnutrition is important. Nutritional interventions, such as malnutrition screening and enteral feeding, play a critical role in preventing sarcopenia in hospitals. Mental health and physical activity evaluations and interventions are also necessary. Even after recovering from COVID-19, there is a risk of developing sarcopenia, requiring continued monitoring. Nutrition and physical activity considerations are vital for prevention and management, necessitating tailored training programs and diet therapy. Mental health should not be overlooked, with regular screening, and community-based interventions. Infrastructure should support physical activity, and mental health services must become more accessible. Community engagement through support groups and peer networks can foster resilience and social connection. Efforts are needed to promote healthy diets and ensure access to nutritious foods.

Acylation stimulating protein/C3adesArg in the metabolic states: role of adipocyte dysfunction in obesity complications.

Adipose tissue, as an endocrine organ, secretes several adipocyte-derived hormones named 'adipokines' that are implicated in regulating energy haemostasis. Substantial evidence shows that white adipose tissue-derived adipokines mediate the link between obesity-related exogenous factors (like diet and lifestyle) and various biological events (such as pre- and postmenopausal status) that have obesity consequences (cardiometabolic disorders). One of the critical aetiological factors for obesity-related diseases is the dysfunction of adipokine pathways. Acylation-stimulating protein (ASP) is an adipokine that stimulates triglyceride synthesis and storage in adipose tissue by enhancing glucose and fatty acid uptake. ASP acts via its receptor C5L2. The primary objective of this review is to address the existing gap in the literature regarding ASP by investigating its diverse responses and receptor interactions across multiple determinants of obesity. These determinants include diet composition, metabolic disorders, organ involvement, sex and sex hormone levels. Furthermore, this article explores the broader paradigm shift from solely focusing on adipose tissue mass, which contributes to obesity, to considering the broader implications of adipose tissue function. Additionally, we raise a critical question concerning the clinical relevance of the insights gained from this review, both in terms of potential therapeutic interventions targeting ASP and in the context of preventing obesity-related conditions, highlighting the potential of the ASP-C5L2 interaction as a pharmacological target. In conclusion, these findings validate that obesity is a low-grade inflammatory status with multiorgan involvement and sex differences, demonstrating dynamic interactions between immune and metabolic response determinants.

Mini Nutrition Assessment-Short Form score is associated with sarcopenia even among nourished people - A result of a feasibility study of a registry.

Objectives: This study aims to identify a new barrier to the use of the Mini-Nutrition Assessment Short-Form (MNA-SF), which is a malnutrition assessment tool for the risk assessment of sarcopenia in a nourished population. Methods: The MNA-SF was completed, and individuals with a score of > 11 were considered nourished in this cross-sectional feasibility study of a registry. Sarcopenia was assessed in 766 healthy, nourished adults (33.4% men, 64.9 ± 7.1 years) based on the European Working Group on Sarcopenia in Older People 2 (EWGSOP2). Results: The MNA-SF scores for non-sarcopenia, pre-, confirmed, and severe sarcopenia were 13.59 ± 0.69, 13.73 ± 0.60, 12.64 ± 0.74, and 12.5 ± 0.71, respectively. The higher MNA-SF score association with pre-sarcopenia [odds ratio (OR): 1.41, 95% confidence interval (CI): 1.06-1.86, P = 0.02], confirmed sarcopenia (OR = 0.25, 95% CI: 0.13-0.49, P < 0.001), and severe sarcopenia (OR = 0.20, 95% CI: 0.09-0.46, P < 0.001) was as significant as in the MNA-SF categories. Individuals with a score = 13 (compared with 14), had a higher risk of confirmed sarcopenia (OR = 10.07, 95% CI: 1.92-52.71, P = 006) and severe sarcopenia (OR = 12.09, 95% CI: 1.24-117.50, P = 0.032). Individuals with a score of 12 had a higher risk of confirmed sarcopenia (OR = 30.94, 95% CI: 4.25-103.02, P < 0.001) and severe sarcopenia (OR = 35.90, 95% CI: 4.25-303.07, P = 0.001) compared with subjects with a score of 14. The models also showed that MNA-SF < 13 could predict sarcopenia. Conclusion: There was a significant association between MNA-SF and confirmed and severe sarcopenia in nourished people. Sarcopenia assessment in people with MNA-SF < 13 can be beneficial. Developing a tool to identify the risk of malnutrition and sarcopenia at the same time based on MNA-SF can be considered.

Animal and plant-based proteins have different postprandial effects on energy expenditure, glycemia, insulinemia, and lipemia: A review of controlled clinical trials.

Dietary proteins have been shown to stimulate thermogenesis, increase satiety, and improve insulin sensitivity in the short and long term. Animal-based proteins (AP) and plant-based proteins (PP) have different amino acid profiles, bioavailability, and digestibility, so it seems to have various short- and long-term effects on metabolic responses. This review aimed to compare the findings of controlled clinical trials on postprandial effects of dietary Aps versus PPs on energy expenditure (EE), lipemia, glycemia, and insulinemia. Data are inconclusive regarding the postprandial effects of APs and PPs. However, there is some evidence indicating that APs increase postprandial EE, DIT, and SO more than PPs. With lipemia and glycemia, most studies showed that APs reduce or delay postprandial glycemia and lipemia and increase insulinemia more than PPs. The difference in amino acid composition, digestion and absorption rate, and gastric emptying rate between APs and PPs explains this difference.

High-dose vitamin D supplementation is related to an improvement in serum alkaline phosphatase in COVID-19 patients; a randomized double-blinded clinical trial.

BACKGROUND: The benefits and harms of vitamin D supplementation in the treatment of COVID-19 have not yet been fully documented. In this study, we aimed to evaluate the effects of high-dose vitamin D supplementation on liver function tests in COVID-19. METHOD: This double-blinded randomized clinical trial was conducted on 140 hospitalized patients aged > 30 years. Patients were randomly allocated to receive either intervention group (n = 70 receiving 50,000 IU of vitamin D capsules orally as a single dose and then 10,000 IU syrup daily from the second day of admission for 30 days) and the control group (n = 70 receiving 1000 IU vitamin D syrup orally per day). Liver function tests (LFT), including alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), and Lactate Dehydrogenase (LDH) were evaluated at baseline and at the end of the intervention. Decision tree analysis was performed to identify the predictors for change in liver enzymes. RESULTS: Among COVID-19 patients, a significant decrease was observed in serum level of ALP between intervention and placebo groups (p = 0.04). In addition, decision tree analysis revealed that GGT, temperature, serum magnesium level at baseline and gender were the most important predictors of ALT changes in COVID-19 patients. CONCLUSION: High-dose vitamin D supplementation improved ALP markers among COVID-19 patients. More randomized controlled trials with longer follow-up times will be required.

Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome.

Background: Time-restricted feeding (TRF) is a kind of intermittent fasting defined as eating and drinking only during a certain number of hours in a day. It has been suggested that intermittent fasting may improve cardiovascular risk factors. This study evaluated the association of TRF and arterial stiffness, using pulse wave velocity (PWV), pulse wave analysis, and arterial age in metabolic syndrome participants. Methods: A cohort study was carried out among metabolic syndrome adults who were followed over the Ramadan fasting period (used as a model of TRF since food was only allowed for about 8 h/day). The subjects were divided into Ramadan fasting and Ramadan nonfasting groups. The aortic PWV and central aortic pressure waveform were measured. Central systolic pressure, central pulse pressure, and indices of arterial compliance, such as augmentation pressure and augmentation index (AIx), were determined from waveform analysis. Results: Ninety-five adults (31.57% female, age: 45.46 ± 9.10 years) with metabolic syndrome (based on the International Diabetes Federation definition) participated in this study. Ramadan fasting and Ramadan nonfasting groups were including 80 and 15 individuals respectively. A significant reduction was seen in PWV (0.29 m/s), central systolic pressure (4.03 mmHg), central pulse pressure (2.43 mmHg), central augmentation pressure (1.88 mmHg), and central AIx (2.47) in the Ramadan fasting group (p = 0.014, p < 0.001, p = 0.001, p = 0.003, and p = 0.036 respectively). There were no significant changes in these indices among the Ramadan nonfasting group. Conclusions: This study suggested that TRF reduces arterial age and improves arterial stiffness among people with metabolic syndrome. This might be considered a beneficial nutrition strategy for extending healthspan (and perhaps longevity).

Association of dietary intake and cervical cancer: a prevention strategy.

INTRODUCTION: Cervical cancer is one of lethal cancers in women. As a global concern, identifying important factors of cancer is a useful strategy for prevention. Due to the role of diet/nutrition factors for cancer, the purpose of our study was to determine the impact of 150 nutrition/vitamin factors and 50 non-nutritional factor in cervical cancer and phase. METHODS: Population samples of 2088 healthy subjects and patients with cervical cancer were investigated. 200 factors such as vitamin E, B1, B6, fruits, HPV, and age were gathered. Deep learning, Decision tree, and correlation matrix were used for modeling and identifying important factors. SPSS 26, R4.0.3, and Rapid miner were utilized for implementation. RESULTS: Our findings indicated that zinc, Iron, Niacin, Potassium, Phosphorous, and Cooper have a beneficial impact in reducing the risk of cervical cancer and progression of phase in Iranian women, as well as Salt, snacks and milk Were identified as high-risk food factors (P value < 0.05 and coefficient correlation > 0.6). Also, alcohol, and sex patient with two groups, HPV positive have an impact on cervical cancer incidence. Phosphorus and selenium in the Micronutrients category (R2 = 0.85, AUC = 0.993) and polyunsaturated fatty acid and salt in the Macronutrients category and other categories of nutrients were identified as the most effective factors in cervical cancer using deep learning (R2 = 0.93, AUC = 0.999). CONCLUSIONS: A diet and rich nutrition can be helpful for the prevention of cervix cancer and may reduce the risk of disease. Additional research is necessary for different countries.

The effect of low dietary inflammatory index score formula on inflammatory, metabolic, and clinical outcomes in critically ill traumatic brain injury patients: A single-blind randomized controlled pilot study.

In traumatic brain injury (TBI) patients, a complex cascade of inflammatory responses are frequently observed following trauma. Numerous dietary agents have long been found to have potential in modulating inflammatory responses. This pilot study, designed an enteral formula with low inflammatory properties based on the dietary inflammatory index (DII®) and evaluated its effect on inflammatory and metabolic factors in critically ill TBI patients. This single-blind randomized controlled pilot study was conducted at the Neurosurgical ICU of Shahid Kamyab Hospital (Mashhad, Iran). A total of 20 TBI patients were randomly assigned to receive either low-DII score or standard formula at the intensive care unit (ICU). The primary outcomes of the study included clinical status, inflammatory biomarkers, APACHE II, SAPS II, SOFA, and NUTRIC scores. The trial groups did not differ significantly in baseline values. Following 14 days of intervention, there was a statistically significant decrease in the APACHE II, SAPS II, and NUTRIC scores and a significant increase in the GCS score in the low-DII score formula group compared to the standard formula group. Over 2 weeks, high sensitivity C-reactive protein (hs-CRP) values of -2.73 (95% CI: -3.67, -1.79) mg/dL in the low-DII score formula group versus 0.65 (95% CI: -0.29, 1.58) mg/dL in controls were obtained. Moreover, the length of hospital stay was longer for the standard formula group than for the low-DII score formula group. The low-DII score formula improves inflammatory factors (serum hs-CRP) and metabolic biomarkers (LDL-c and FBS). Furthermore, clinical outcomes, including the length of hospital stay and disease severity, appear to be enhanced.

Postprandial effects of dietary protein source on metabolic responses, appetite, and arterial stiffness indices in overweight and obese men: the study protocol for a randomized crossover clinical trial.

BACKGROUND: Different dietary protein sources are supposed to have various effects on metabolic responses and arterial stiffness in the postprandial period. This study aims to assess the postprandial effects of dietary protein sources, including animal-based protein (AP) and plant-based protein (PP), as part of a high-protein breakfast on appetite response, energy metabolism, and arterial stiffness in overweight and obese men. METHODS: This acute randomized crossover clinical trial will be conducted at the Persian study research center at Imam Reza Hospital, affiliated with the Mashhad University of Medical Sciences, located in the northeast of Iran. Forty-six healthy overweight, and obese men aged 18-60 years will be enrolled based on the eligibility criteria. The subjects will complete two interventions (high-protein AP and PP meals) with 1 week washout period. The primary outcome will be the acute effect of the two test meals on appetite response, energy metabolism parameters, including resting metabolism rate (RMR), diet-induced thermogenesis (DIT), and substrate oxidation (SO), and arterial stiffness indices, including pulse wave velocity (PWV) and pulse wave analysis (PWA). The secondary outcomes include changes in lipemia, glycemia, and insulinemia. DISCUSSION: The findings of this study will provide novel insight regarding the acute effects of different protein sources on energy metabolism, appetite, and arterial stiffness as a significant cardiovascular disease (CVD) risk factor. It will help dieticians develop effective and efficient meal plans to improve weight reduction and maintenance in overweight/obese individuals. TRIAL REGISTRATION: Iranian Registry of Clinical Trials; code: IRCT20211230053570N1; registered on February 10, 2022.

The Effects of Different Temperaments on Vascular Parameters: A Pilot CrossOver Randomized Controlled Trial.

BACKGROUND: According to the Persian Medicine (PM) point of view, the function of the cardiovascular system and the risk of cardiovascular events would be different between subjects having warm and cold temperaments. Moreover, different foods in terms of temperament may lead to different acute and chronic effects on the body. OBJECTIVES: We investigated the postprandial effects of PM-based warm and cold test meals on arterial stiffness indices in healthy men with warm and cold temperaments. METHODS: Twenty-one eligible warm or cold temperament subjects with a similar range of age, weight, and heights were enrolled in this pilot cross-over randomized controlled trial study during February- October 2020. Two test meals (cold and warm PM-based temperament foods) were designed as different interventions. Pulse wave velocity (PWV) and pulse wave analysis (PWA) was obtained at the baseline state (following 12 hours fasting), 0.5, 2, and 4 hours after the test meal consumption during each test day. RESULTS: Warm temperament participants had higher values of lean body mass, total body water, and protein content (P = 0.03, 0.02, and 0.02, respectively). Cold temperament individuals had higher aortic heart rate (HR) following 12 hours of fasting (P <0.001). On the other hand, the augmentation pressure (AP) of warm temperament individuals was higher than the colds (P= <0.001). CONCLUSION: According to the results of the present study, although warm temperament individuals could have higher arterial stiffness at the fasting state, arterial stiffness indices had a greater reduction following warm-temperament meal intake compared to cold-temperament meal. TRIAL REGISTRATION NUMBER: International Clinical Trials Registry Platform IRCT20200417047105N1 (Where the full trial protocol can be accessed).

Impact of gastric bypass surgery on the liver fibrosis of patients with extreme obesity and nonalcoholic fatty liver disease in 30-month follow-up.

Roux-en-Y gastric bypass surgery (RYGB) has shown efficacy in weight loss, but its role in liver fibrosis remains unknown and contentious. The present study aimed to investigate the effect of RYGB on liver fibrosis measured by non-invasive methods and assess the impact of weight loss on hepatic fibrosis in the midterm follow-up after RYGB. This longitudinal study was conducted on patients with extreme obesity, and NAFLD referred for RYGB during 2016-2018 for 3 years after their surgery. A liver biopsy was performed intraoperatively. The patient demographics, anthropometrical parameters, biochemical variables, and Liver stiffness (LS) using two-dimensional shear-wave elastography were recorded and analyzed before and in short-term and midterm follow-ups. Fifty-four patients were included with a mean age of 40.3 years; 83.3% were women. At a median follow-up of 30 months (range: 24-36 months), the excessive body mass index loss of the patients was 78.1% and, a significant reduction was seen in LS measurement. Two patients (4%) had worsening showed in the fibrosis stage, 28 (54%) no change, and 24 (42%) showed improvement, 30 months after the surgery. Moreover, the liver fibrosis stage regressed to F0 in 91% of the patients. Hepatic fibrosis resolved in the midterm follow-up in some patients whose fibrosis had progressed and deteriorated in the short-term follow-up. In addition, Liver enzymes were decreased. RYGB seems to be an effective procedure for sustained weight loss and improved liver fibrosis in EO and NAFLD patients in midterm follow-up.

Eating frequency has an inverse correlation with adiposity measures and non-invasive arterial stiffness parameters in healthy adult people.

BACKGROUND: Lifestyle modifications have been recommended as an essential treatment approach for cardiovascular diseases. Recent studies have shown that eating frequency (EF) correlates with hypertension and related risk of organ damage. This study aimed to examine critical clinical implications to evaluate the association of EF with arterial stiffness parameters as an early marker of atherosclerosis manifestations. METHODS: A cross-sectional descriptive study was performed on 658 participants of the PERSIAN Organizational Cohort study in Mashhad, aged 30-70 years. Arterial stiffness was assessed by measurement markers of arteriosclerosis, including arterial age, augmentation index (AIx), augmentation pressure (AP), carotid-femoral pulse wave velocity (Cf-PWV), and central blood pressure. Differences in anthropometric indices, blood indices, and arterial stiffness parameters were evaluated across EF groups. RESULTS: Our data demonstrate that EF was positively correlated with total daily energy intake, and favourable profiles of adiposity and blood lipids. Subjects with an increased EF, had significantly lower AIx, AP, Arterial Age and Central blood pressure (P for trend<0.001) as compared to Lowest EF and not significant with PWV (P for trend, 0.19). Arterial stiffness was also significantly lower in those with increased EF compared with subjects with low EF. By Linear regression analysis, after adjustment for Confounding factors, except PWV, EF showed the associations with all of the non-invasive arterial stiffness parameters. CONCLUSION: Increased EF is associated with a lower wave reflection and blood pressure in the central arteries.

Identifying the Predictors of Short Term Weight Loss Failure after Roux-En-Y Gastric Bypass.

Introduction: Gastric bypass surgery is a gold standard therapy for severe obesity. This study aimed to evaluate anthropometric predictors for short-term excess weight loss (EWL) after Roux-en-Y gastric bypass surgery (RYGB) in a sample of severely obese patients. Materials and Methods: This cohort study was conducted on severely obese candidates for RYGB bariatric surgery in Mashhad, Iran. Indirect calorimetry, anthropometric measurements, and body composition data were collected before, one, and six months after RYGB. Results: Fifty-four participants (43, 79.6% women and 11, 20.4% men) with a mean age of 39.63 ± 9.66 years participated in this study. The mean total weight and BMI loss within six months were 32.89 ± 20.22 kg and 12.37 ± 7.34 kg/m2, respectively. The mean reduction in adipose tissue and fat-free mass was 24.49 kg and 7.46 kg, respectively. The mean resting metabolism rate (RMR) reduction at one and six months after RYGB was 260.49 kcal and 396.07 kcal, respectively. There was a significant difference in mean RMR between the baseline and one and six months after RYGB (p < 0.001). There was no significant gender difference in mean weight and BMI loss percentage at six months post-RYGB (p > 0.05). Baseline skeletal muscle mass (SMM), excess BMI loss (EBMIL) at first month after surgery, and baseline neck circumference (NC) could predict EWL six months after surgery. Conclusion: Reduced RMR shortly after RYGB may be due to FFM reduction. Some anthropometric and their acute changes after RYGB may predict the short-term EWL in RYGB patients.

The effects of synbiotic supplementation on enteral feeding tolerance, protein homeostasis, and muscle wasting of critically ill adult patients: a randomized controlled trial.

BACKGROUND: Enteral feeding intolerance, energy-protein malnutrition, and muscle wasting are common conditions in the critical care setting. The primary aim of this study was to investigate the effect of synbiotic supplementation on enteral feed volume, energy and protein homeostasis, and muscle mass maintenance in critically ill adult patients. METHODS: A consecutive of 42 patients admitted to the Edalatian Medical ICU, requiring enteral nutrition (EN), were prospectively randomized to receive the synbiotic capsule (containing a combination of Lactobacillus, Bifidobacterium, Streptococcus, and fructooligosaccharides) or placebo (21 patients in each group) for a maximum of 14 days. Enteral intolerance and energy homeostasis were evaluated on a daily basis. Nitrogen balance and 24-h urine creatinine excretion were recorded on days 1 and 14. Mid-arm circumference was recorded every 3 days. RESULTS: Mean EN volume, energy, and protein intake per day were 962.5 ± 533.82 ml, 770 ± 427.05 kcal, and 38.5 ± 21.35 g (fourth day) vs. 590 ± 321.1 ml, 472 ± 256.81 kcal, and 23.6 ± 12.84 g (first day) in the synbiotic group (p < 0.05). Changes in the placebo group were not statistically significant. On day 1, nitrogen balance (NB) was - 19.84 ± 8.03 in the synbiotic vs. - 10.99 ± 9.12 in the placebo group (p = 0.003). On day 14, NB was - 14.18 ± 13.05 in the synbiotic and - 9.59 ± 7.71 in the placebo group (p = 0.41). Mid-arm circumference (MAC), 24-h urine creatinine, and creatinine-height index were almost steady in the synbiotic group, while they decreased in the placebo group. CONCLUSION: Overall, it can be concluded that enteral nutrition supplemented with synbiotics has no statistically significant effect on energy and protein homeostasis and muscle mass maintenance of critically ill patients on day 14, but it can increase enteral feed volume and energy and protein intake during the first 4 days of ICU admission. TRIAL REGISTRATION: The trial protocol has been approved in Iranian Registry of Clinical Trials on March 17, 2019. The registration reference is IRCT20190227042857N1.

Effect of beetroot or beetroot plus vitamin C supplementation on cardiovascular function in patients with coronary artery disease: protocol for a double-blind, placebo-controlled, randomised trial.

INTRODUCTION: Coronary artery disease (CAD), classified into the atherosclerosis category, is a prevalent cardiovascular disease worldwide that is associated with serious comorbidities and death. The purpose of this study was to evaluate the effect of beetroot/beetroot plus vitamin C on cardiovascular health status and function in patients with CAD. METHOD AND ANALYSIS: A randomised, placebo-controlled, double-blind clinical trial to recruit 90 patients with CAD at the cardiac outpatient clinic and Imam Reza Hospital, Mashhad, Iran. Participants will be divided into three groups: (1) Those who receive 500 mg three times a day of beetroot capsules, (2) Those who receive 500 mg three times a day of beetroot plus vitamin C capsules, and (3) Those who receive placebo capsules three times a day for 4 weeks. Pulse wave velocity, Augmentation Index, heart rate, volume of oxygen (VO2) max/VO2 peak, peak heart rate, blood pressure, interleukin 6 (IL-6), high sensitivity C reactive protein, intercellular adhesion molecule, vascular cell adhesion molecule, lipid profile and anthropometry will be measured at the beginning and end of the intervention. ETHICS AND DISSEMINATION: This study was approved by the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.MEDICAL.REC.1399.717). All participants will be asked to complete the consent form at the beginning of the study. The results will be actively disseminated through peer-reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Iranian Registry of Clinical Trials, IRCT20210217050393N1 (registered 16 May 2021).

The effects of high dose vitamin D supplementation as a nutritional intervention strategy on biochemical and inflammatory factors in adults with COVID-19: Study protocol for a randomized controlled trial.

Introduction: Low serum vitamin D has been shown to be a risk factor for Coronavirus 2019 (COVID-19). The aim of this study was to assess the effects of high dose vitamin D supplementation on hs-CRP, ESR and clinical outcomes, including duration of hospitalization, quality of life and New York Heart Association (NYHA) Functional Classification, in adults with COVID-19. Methods: This double-blind, randomized control trial will be conducted on patients with RT-PCR and/or chest CT scan diagnosis of COVID-19 admitted in Imam Reza Hospital, Mashhad, Iran. Participants will be randomized into control and intervention groups based on randomization sampling. The intervention group will receive soft gel containing 50,000 IU vitamin D on the first day followed by 10,000 IU/day through a supplement drop daily for 29 days. The control group will receive 1000 IU vitamin D daily through supplement drop and a placebo soft gel. All participants will undergo laboratory assessment including inflammatory markers, serum 25)OH)D, complete blood count (CBC), liver and renal profile, lipid profile and erythrocyte sedimentation rate (ESR) at baseline and at day 30. The mortality rate will be recorded in both groups. Results: Data will be presented using descriptive statistics. Comparison of changes in study parameters over the study period will be performed using analysis of covariance adjusting for possible confounders. Conclusions: The findings of this will provide evidence on the effects of high dose vitamin D supplementation on inflammatory markers in hospitalized COVID-19 patients.

The effect of early enteral nutrition supplemented with synbiotics on lipid and glucose homeostasis in critically ill patients: A randomized controlled trial.

BACKGROUND AND AIMS: The aim of the present study was to investigate the effects of gut microbiota modulation through synbiotic supplementation on lipid and glucose homeostasis in tube-fed critically-ill adult patients. METHODS: This study is placebo-controlled, parallel, single-center, double-blind clinical trial. 42 patients were randomly distributed in placebo and synbiotic groups to receive intervention for a maximum of 14 days. Serum levels of fasting glucose, total cholesterol, and triglycerides, insulin, and free fatty acids were obtained from blood sampling at baseline and the end of the study. Also, insulin resistance was determined by homeostasis model assessment of insulin resistance (HOMA-IR). RESULT: Fasting glucose level (Day0 = 87.84 ±â€¯15.51, Day14 = 83.76 ±â€¯8.71 mg/dl, P = 0.51), fasting insulin level (Day0 = 9.46 ±â€¯7.31, Day14 = 7.97 ±â€¯5.19 mIU/L, P = 1.00), and HOMA index (Day0 = 1.89 ±â€¯1.48, Day14 = 1.72 ±â€¯1.17, P = 0.75) during the study were decreasing in both groups, but the decreases were not significant. Serum levels of total cholesterol, triglyceride, and free fatty acidsat the beginning of the study were 114.18 ±â€¯43.43 mg/dl, 146.59 ±â€¯53.99 mg/dl, 0.83 ±â€¯0.57 mmol/L, and at the end of the study were 129.10 ±â€¯39.05 mg/dl, 127.40 ±â€¯91.88 mg/dl, 0.88 ±â€¯0.77 mmol/L, respectively. None of these changes were significant either (P = 0.99, P = 0.38, P = 0.90, respectively). CONCLUSIONS: According to our findings, synbiotics supplementation in critically ill patients has no significant effect on lipid and glucose profile.