Effect of nano-curcumin supplementation on angina status, and traditional and novel cardiovascular risk factors in overweight or obese patients with coronary slow flow phenomenon: a randomized double-blind placebo-controlled clinical trial.

BACKGROUND: Cardiovascular events and poor quality of life are frequently observed in patients with coronary slow flow phenomenon (CSFP). This trial evaluated the effect of nano-curcumin supplement containing curcuminoids, as multifunctional nutraceuticals, on angina status, and some traditional and novel cardiovascular risk factors in overweight or obese patients with CSFP. METHODS: In this double-blind, randomized, placebo-controlled clinical trial, 42 overweight or obese patients with CSFP received either 80 mg/day of nano-curcumin or placebo for 12 weeks. Seattle angina questionnaire (SAQ) as a clinical measure of angina status, circulating endocan, adropin, homocysteine, lipid profile, and the novel scores of visceral adiposity index (VAI) and waist-triglyceride index (WTI) were assessed before and after the intervention. The independent samples t-test, Mann-Whitney test, analysis of covariance, Chi-square, and Fisher's exact tests were used where appropriate. RESULTS: All domains of SAQ including physical limitation, angina stability, angina frequency-severity, treatment satisfaction, and disease perception and quality of life improved significantly in the nano-curcumin compared with the placebo group. No significant changes were observed in serum endocan, adropin, and homocysteine following the intervention. Triglycerides, triglyceride/high-density lipoprotein cholesterol ratio, WTI and VAI values improved significantly only within the nano-curcumin group. CONCLUSIONS: Supplementation with 80 mg/day nano-curcumin (containing curcuminoids) for 12 weeks significantly improved clinically important disease-specific aspects of health in patients with CSFP. Some traditional and novel cardiovascular risk factors improved significantly only compared with the baseline values, which need further investigation. TRIAL REGISTRATION: This study was approved by the Ethics Committee of Tehran University of Medical Sciences (IR.TUMS.VCR.REC.1398.794). The study protocol was registered at Iranian Registry of Clinical Trials by IRCT20131125015536N8 registration ID at 19.06.2019.

Effects of virgin coconut oil consumption on serum brain-derived neurotrophic factor levels and oxidative stress biomarkers in adults with metabolic syndrome: a randomized clinical trial.

BACKGROUND AND AIM: Metabolic syndrome is associated with health conditions and neurological disorders. Brain-derived neurotrophic factor (BDNF) plays a protective role on the nervous system. Decreased levels of BDNF have been shown in MetS and neurodegenerative diseases. There is promising evidence regarding the anti-inflammatory antioxidant, and neuroprotective properties of virgin coconut oil (VCO). The aim of this study was to evaluate the effects of VCO consumption on serum BDNF levels, oxidative stress status, and insulin resistance in adults with MetS. METHODS: This randomized controlled clinical trial was conducted on 48 adults with MetS aged 20-50 years. The intervention group received 30 ml of VCO daily to substitute the same amounts of oil in their usual diet. The control group continued their usual diet. Serum BDNF levels, total antioxidant capacity (TAC), malondialdehyde (MDA) as well as HOMA-IR and QUICKI index were measured after four weeks of intervention. RESULTS: VCO consumption significantly reduced serum levels of MDA (p = .01), fasting insulin (p < .01) and HOMA-IR index (p < .01) and increased serum TAC (p < .01) and QUICKI index (p = .01) compared to the control group. Serum BDNF levels increased significantly in VCO group compared to the baseline (p = .02); however, this change was not significant when compared to the control group (p = .07). CONCLUSION: VCO consumption improved oxidative stress status and insulin resistance and had a promising effect on BDNF levels in adults with MetS. Further studies are needed to understand the long-term effects of VCO consumption.

Effects of hydrolyzed collagen alone or in combination with fish oil on the gut microbiome in patients with major burns.

Burns are associated with gut dysbiosis. Collagen peptides and omega-3 fatty acids (FAs) are suggested to improve wound healing and the inflammatory response. These are also correlated with microbiome colonization. Therefore, the present study aimed to investigate the effect of hydrolyzed collagen alone or in combination with fish oil on specific species of the gut microbiome in patients with major burns. In this randomized double-blind clinical trial, 57 adults (aged 18-60 years) with 20-45% total body surface area burns were randomised into three groups to receive either 40 gr hydrolyzed collagen +10 ml sunflower oil, 40 g hydrolyzed collagen +10 ml fish oil or placebo, divided into two daily drinks, for two weeks. Gut bacteria were measured using the real-time quantitative polymerase chain reaction (qPCR) method. The mean concentration of Bifidobacterium was significantly reduced in the control (P = 0.002) and collagen (P = 0.005) groups compared with the baseline values, whereas no significant change was observed in the collagen omega-3 group. The Firmicutes to Bacteroidetes ratio decreased significantly in the collagen group (p = 0.002) after supplementation compared to baseline . No significant changes in concentration of Lactobacillus, Enterobacteriaceae, and F.prausnitzii were observed between or within the study groups. Two weeks of supplementation with collagen and omega-3 FAs in patients with major burns did not result in a significant difference in the concentration of bacteria measured between the study groups. However, the addition of omega-3 FAs prevented a significant reduction in gut Bifidobacterium. Future studies are suggested to investigate the potential efficacy of these nutrients in improving the gut microbiota and clinical outcomes in major burns. REGISTRATION NUMBER: IRCT20131125015536N9.

Effects of oleoylethanolamide supplementation on the expression of lipid metabolism-related genes and serum NRG4 levels in patients with non-alcoholic fatty liver disease: A randomized controlled trial.

BACKGROUND: This study investigated the effects of oleoylethanolamide (OEA) supplementation on the expression levels of SIRT1, AMPK, PGC-1α, PPAR-γ, CEBP-α and CEBP-ß genes and serum neuregulin 4 (NRG4) levels in patients with non-alcoholic fatty liver diseases (NAFLD). METHODS: Sixty obese patients with NAFLD were equally allocated into either OEA or placebo group for 12 weeks. The mRNA expression levels of genes were determined using the reverse transcription polymerase chain reaction (RT-PCR) technique. Serum NRG4 level was also assessed using an enzyme-linked immunosorbent assay (ELISA) kit. RESULTS: At the endpoint, mRNA expression levels of SIRT1(p = 0.001), PGC-1α (p = 0.011) and AMPK (p = 0.019) were significantly higher in the OEA group compared to placebo group. However, no significant differences were observed in the expression levels of PPAR-γ, CEBP-α and CEBP-ß between the two groups. Serum NRG4 levels significantly increased in the OEA group compared with the placebo group after controlling for confounders (p = 0.027). In the OEA group, significant relationships were found between percent of changes in the expression levels of the SIRT1, AMPK and PGC-1α as well as serum NRG4 level with percent of changes in some anthropometric measures. Moreover, in the intervention group, percent of changes in high-density lipoprotein cholesterol was positively correlated with percent of changes in the expression levels of the SIRT1 and AMPK. While, percent of changes in triglyceride was inversely correlated with percent of changes in the expression levels of SIRT1. CONCLUSION: OEA could beneficially affect expression levels of some lipid metabolism-related genes and serum NRG4 level. "REGISTERED UNDER IRANIAN REGISTRY OF CLINICAL TRIALS IDENTIFIER NO: IRCT20090609002017N32".

Implications of the Serum Concentrations of Neuregulin-4 (Nrg4) in Patients with Coronary Artery Disease: A Case-Control Study.

Background: Neuregulin-4 (Nrg4), a novel brown fat-enriched factor, has been reported to play a crucial role in developing metabolic disorders. The current case-control study aimed to investigate the association between serum Nrg4 and coronary artery disease (CAD). Methods: This study enrolled 43 patients with CAD and 43 subjects with normal coronary arteries diagnosed by coronary angiography. Anthropometric and biochemical parameters were measured and recorded. The serum Nrg4 level was determined using the enzyme-linked immunosorbent assay. The relationships between circulating Nrg4 and CAD and other clinical parameters were analyzed. A receiver operating characteristic analysis was applied to assess the utility of Nrg4 in identifying CAD. Results: The study population comprised 86 patients, including 64 men (74.4%), at a mean age of 57.83±6.01 years. Patients with CAD had significantly lower serum Nrg4 than the control group (P<0.001). The serum Nrg4 level was negatively correlated with anthropometric variables, including the body mass index, waist circumference, and the waist-to-hip ratio, fasting blood glucose, and the triglyceride-glucose index (P<0.05). In multivariable-adjusted regression analysis, the odds of CAD decreased by 46% per 1 SD elevation in the serum Nrg4 level (OR, 0.54; 95% CI, 0.40 to 0.73; P<0.001) after controlling for potential confounders. Nrg4 showed a significantly high area under the curve value (AUC, 0.85; 95% CI, 0.75 to 0.94) with 81.4% sensitivity and 95.3% specificity to identify CAD. Conclusion: Generally, the serum level of Nrg4 declines in patients with CAD, which might be an independent risk factor for CAD.

Effect of diet low in advanced glycation end products on appetite, body composition, and brown adipose tissue markers in patients with coronary artery disease treated with angioplasty: A randomized controlled trial.

Background: Recent changes in dietary habits have resulted in increased intake of advanced glycation end products (AGEs), which are known to have a predominant contribution to the pathogenesis and complications of coronary artery disease (CAD). AGEs are also thought to induce weight gain by affecting appetite, energy expenditure, and brown adipose tissue (BAT). Here, we investigated whether the restriction of dietary AGEs could affect appetite, body composition, anthropometric indices, and BAT-derived markers in CAD patients treated with angioplasty. Materials and Methods: Forty-two stented CAD patients were randomly allocated into two groups that received either a low-AGEs or a control diet for 12 weeks. At baseline and postintervention, fasting blood samples were analyzed for total AGEs, nesfatin-1, and BAT-derived markers (fibroblast growth factor 21 and neuregulin 4). Subjective appetite ratings and body composition were evaluated using the Visual Analog Scale (VAS) and bioelectric impedance analysis. Anthropometric indices, including fat mass index (FMI), abdominal volume index (AVI), and body adiposity index (BAI), were calculated through the relevant formula. Results: Restricting dietary AGEs for 12 weeks could cause a significant reduction in weight, FMI, AVI, and BAI (P < 0.05) compared to the comparison group. In addition, VAS data analyses indicated a significant decrease in the sense of hunger and prospective food intake (P < 0.05) in the intervention group compared to the comparison group. No significant difference was seen in the measured biochemical markers between the two groups. Conclusion: This study indicated that the low-AGEs diet could decrease appetite, weight, and anthropometric indices in stented CAD patients.

The relationship of circulating neuregulin 4 and irisin, and traditional and novel cardiometabolic risk factors with the risk and severity of coronary artery disease.

BACKGROUND AND AIMS: Neuregulin 4 (NRG4) and irisin are adipokines that have been suggested to be associated with cardiometabolic risk factors and coronary artery disease (CAD), but the data are inconclusive. This study aimed to investigate the relationship between circulating NRG4 and irisin and cardiometabolic risk factors with CAD risk and severity. METHODS AND RESULTS: In this cross-sectional study, the presence of CAD and the severity of stenosis (gensini score) were documented based on coronary angiography in 166 adults. Circulating NRG4 and irisin, glucose homeostasis markers, hs-CRP, lipid profiles, blood pressure, and anthropometric measurements were assessed as well. Age (p = 0.005), sex (p = 0.008), SBP (p = 0.033), DBP (p = 0.04), MAP (p = 0.018), FBG (p = 0.012), insulin (p = 0.039) and HOMA-IR (p = 0.01) were significantly associated with odds of having CAD. The final logistic regression model showed that age, sex, HOMA-IR, and MAP were the most important determinants of having CAD. There were no significant associations between circulating irisin and NRG4 with odds of having CAD. The final general linear model showed that being men (ß = 17.303, 95% CI: 7.086-27.52, P = 0.001), age (Aß = 0.712, 95% CI: 0.21-1.214, P = 0.006), HOMA-IR (Aß = 2.168, 95% CI: 0.256 to 4.079, P = 0.027), and NRG4 level (ß = 1.836, 95% CI: 0.119-3.553, P = 0.036) were directly associated with higher gensini score. Participants with the three-vessel disease had a mean increase of about 5 units in circulating irisin compared to those with no clinical CAD (ß = 5.221, 95% CI: 0.454-9.987, p = 0.032). CONCLUSIONS: This study showed that the adipokines NRG4 and Irisin might be associated with the severity of coronary stenosis.

The effect of vitamin C on oxidative stress indices and skin regimentation of vitiligo patients.

It has been suggested that vitamin C is involved in suppressing stress oxidation signaling in vitiligo disease. However, the effect of vitamin C supplementation on stress oxidative factors has not been investigated in vitiligo subjects. This study was designed to examine the effects on vitamin C supplementation on serum levels of stress oxidative factors and regimentation in vitiligo patients. Forty-four vitiligo patients will be recruited in this study. After block matching for sex and number of phototherapy sessions, they will be randomly assigned to receive 1000 mg/d vitamin C or placebo for 8 weeks. The weight, height, and waist circumference of participants will be measured. Determination of serum stress oxidative indices (CAT, SOD, GPX, MDA, TOS, TAC) will be done at study baseline and at the end of the trial. Also, the regimentation will be determined using the VASI score. This is the first randomized controlled trial that will determine the effect of vitamin C supplementation on serum levels of stress oxidative indices and regimentation in vitiligo patients. The results of this trial will provide clinical evidence on the effectiveness of vitamin C supplementation in controlling oxidative stress in vitiligo patients. Trial registration number: This study is registered in the Iranian Registry of Clinical Trials website (available at http://www.irct.ir , identifier: IRCT20230123057193N1), Registration date: 2023/04/17.

Impact of Dietary Advanced Glycation End-Product Restriction on Insulin Resistance and Anthropometric Indices in Coronary Artery Patients Treated with Percutaneous Coronary Intervention: A Randomized Controlled Trial.

Background: Insulin resistance (IR), even in its subclinical state, is a significant risk factor for the onset and progression of coronary artery disease (CAD). IR is a multifactorial condition, and dietary composition is a factor associated with its development. Elevated advanced glycation end products (AGEs) in the body, secondary to highly processed food consumption, can impair glucose metabolism. The present study investigated whether a restricted AGE diet could affect insulin sensitivity and anthropometric indices reflecting visceral adipose tissue in nondiabetic CAD patients. Methods: This trial randomly allocated 42 angioplasty-treated patients to follow either low-AGE or control diets based on the AHA/NCEP guidelines for 12 weeks. Serum levels of total AGEs, insulin, HbA1c, and fasting blood sugar, as well as anthropometric measurements, were evaluated before and after the intervention. The Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and anthropometric indices were calculated according to the proposed formula. The patients' health status was assessed using the Seattle Angina Questionnaire (SAQ) at baseline and after the intervention. Results: Our study showed a significant reduction in anthropometric indices in the low-AGE group after 12 weeks. Insulin levels and IR decreased during the low-AGE diet. No significant changes were observed in the other serum biochemical markers. All SAQ domains significantly decreased in both groups, except for Treatment Satisfaction. Conclusion: A low-AGE diet for 12 weeks had beneficial effects on HOMA-IR and insulin levels in patients with CAD. Regarding the fundamental role of AGE in IR development and body fat distribution, AGE restriction may positively affect these patients.

Effect of a collagen-enriched beverage with or without omega-3 fatty acids on wound healing, metabolic biomarkers, and adipokines in patients with major burns.

BACKGROUND & AIMS: This study investigated the effects of collagen hydrolysate and omega-3 fatty acids (FAs) on the rate and quality of wound healing, metabolic disorders, and adipose-derived peptides in patients with major burns. METHODS: In this randomized clinical trial, 66 patients with 20-45% deep partial or full-thickness burns were randomly assigned to three groups to receive either a beverage containing collagen (40 gr/d), collagen (40 gr/d) plus 3 gr/d omega-3 (ω-3) FAs, or placebo for four weeks. Wound healing rate, Vancouver scar scale (VSS), as well as baseline, weeks two and three serum concentrations of adiponectin, fibroblast growth factor 21 (FGF21), neuregulin 4 (NRG4), transforming growth factor (TGF)-ß1, and pre-albumin/hs-CRP ratio were assessed. RESULTS: The wound healing rate during the weeks post-burn (p = 0.006 and p = 0.01), and days of 95% (21.3 ± 6.8 and 22.9 ± 8.7 vs. 34.3 ± 14.8 days, p = 0.003 and p = 0.03) and complete (26 ± 7.7 and 27.4 ± 9.4 vs. 41.1 ± 16.6 days, p = 0.003 and p = 0.01) wound healing were significantly better with Collagen and Collagen. ω-3 compared to the placebo group. The VSS was significantly lower, indicated better scar status, in the both intervention groups compared to the placebo (p = 0.02 and p = 0.01). Wound healing outcomes were not statistically different between the Collagen and Collagen. ω-3 groups. Hs-CRP/pre-albumin ratio was significantly lower in the Collagen. ω-3 than the placebo group at week three (1.2 ± 1.9 vs. 4.8 ± 7.7 dl/l, p = 0.03). The significant decrease in serum adiponectin seen during the trial course within the placebo (10 ± 8.8 to 5.8 ± 4.9 mg/l, p = 0.03) and Collagen (11.8 ± 14 to 8.6 ± 11.7 mg/l, p = 0.03) groups was prevented in the Collagen. ω-3 group (p = 0.4). Circulating FGF21 decreased significantly within the Collagen (p = 0.005) and Collagen. ω-3 (p = 0.02) groups at the end of week three compared to the baseline. CONCLUSIONS: Adding collagen hydrolysate as part of adjunctive therapy improved wound healing rate and quality. These findings as well as the efficacy of omega-3 FAs need to be further confirmed in larger populations. This study was registered with the Iranian Registry of Clinical Trials (IRCT20090901002394N42).

The relationship between low-carbohydrate diet score, dietary insulin index and load with obesity in healthy adults.

PURPOSE: Carbohydrate intake and insulinemic potential of diet are suggested to be correlated with the development of different chronic diseases. Considering the limited research on obesity, this study aimed to investigate the association of dietary insulin index (DII), dietary insulin load (DIL), and low-carbohydrate diet score (LCDS) with body weight and obesity in healthy adults. METHODS: In this cross-sectional study, DII, DIL, and LCDS were calculated using relevant formulas based on dietary intakes obtained by a valid 168-item food frequency questionnaire, in 393 otherwise healthy adults of either normal-weight, overweight, or obese. RESULTS: Individuals in the highest tertile of DIL and DII had respectively 73% (OR: 0.27, 95% CI 0.08-0.94, p = 0.049) and 50% (OR: 0.5, 95% CI 0.26-0.96, p = 0.038) lower odds of being overweight compared to the lowest tertile, after adjusting the effects of age, sex, and dietary energy intake. Participants in the highest tertile of DIL had 92% greater odds of being obese compared to the lowest tertile, but this association did not remain significant after adjusting the effect of energy intake. Individuals in the highest tertile of LCDS had about 2 times odds of being overweight compared with those in the lowest tertile (OR: 2.04, 95% CI 1.04-4.01, p = 0.049). There was no relationship between being obese and tertiles of LCDS. CONCLUSION: Higher dietary carbohydrate intake and insulinemic potential of diet could not be considered independent dietary risk factors for overweight or obesity. LEVEL OF EVIDENCE: Level III: evidence obtained from an observational study.

Effect of nanocurcumin supplementation on the severity of symptoms and length of hospital stay in patients with COVID-19: A randomized double-blind placebo-controlled trial.

It has been more than a year since the outbreak of COVID-19, and it is still the most critical issue of the healthcare system. Discovering effective strategies to treat infected patients is necessary to decrease the mortality rate. This study aimed to determine the effects of nanocurcumin on the severity of symptoms and length of hospital stay (LOS) in COVID-19 patients. Forty-eight COVID-19 patients were randomly assigned into nanocurcumin (n = 24) and placebo (n = 24) groups receiving 160 mg/day nanocurcumin or placebo capsules for 6 days. Mean differences of O2 saturation were significantly higher in patients who received nanocurcumin supplements (p = 0.02). Also, nanocurcumin treatment significantly reduced the scores of domains 3 and 4 and the total score of Wisconsin Upper Respiratory System Survey (WURSS-24), indicating milder symptoms in the treatment group (p = 0.01, 0.03, and 0.01 respectively). Besides, the LOS in curcumin groups was lower than in the placebo group, although the difference was not statistically significant (6.31 ± 5.26 vs. 8.87 ± 8.12 days; p = 0.416). CBC/differentiate, hs-CRP level and the pulmonary involvement in CT scan were not different between the two groups. As nanocurcumin can be effective in increasing O2 saturation and reducing the severity of symptoms in COVID-19 patients, it could probably be used as a complementary agent to accelerate the recovery of patients.

Effects of naringenin supplementation on cardiovascular risk factors in overweight/obese patients with nonalcoholic fatty liver disease: a pilot double-blind, placebo-controlled, randomized clinical trial.

OBJECTIVE: Although several experimental models have suggested promising pharmacological effects of naringenin in the management of obesity and its related disorders, the effects of naringenin supplementation on cardiovascular disorders as one of the main complications of nonalcoholic fatty liver disease (NAFLD) are yet to be examined in humans. METHODS: In this double-blind, placebo-controlled, randomized clinical trial, 44 overweight/obese patients with NAFLD were equally allocated into either naringenin or placebo group for 4 weeks. Cardiovascular risk factors including atherogenic factors, hematological indices, obesity-related parameters, blood pressure, and heart rate were assessed pre- and postintervention. RESULTS: The atherogenic index of plasma value, serum non-HDL-C levels as well as total cholesterol/high-density lipoprotein cholesterol (HDL-C), triglyceride/HDL-C, low-density lipoprotein cholesterol/HDL-C, and non-HDL-C/HDL-C ratios were significantly reduced in the intervention group, compared to the placebo group post intervention (P < 0.05). Moreover, there was a significant reduction in BMI and visceral fat level in the intervention group when compared with the placebo group (P = 0.001 and P = 0.039, respectively). Furthermore, naringenin supplementation could marginally reduce systolic blood pressure (P = 0.055). Mean corpuscular hemoglobin increased significantly in the naringenin group compared to the placebo group at the endpoint (P = 0.023). Supplementation with naringenin also resulted in a marginally significant increase in the mean corpuscular hemoglobin concentration when compared with the placebo group (P = 0.050). There were no significant between-group differences for other study outcomes post intervention. CONCLUSION: In conclusion, these data indicate that naringenin supplementation may be a promising treatment strategy for cardiovascular complications among NAFLD patients. However, further trials are warranted.

Effects of naringenin supplementation in overweight/obese patients with non-alcoholic fatty liver disease: study protocol for a randomized double-blind clinical trial.

INTRODUCTION: Non-alcoholic fatty liver disease (NAFLD) is one of the main causes of chronic liver disease worldwide. Flavonoids, a group of natural compounds, have garnered a great deal of attention in the management of NAFLD because of their profitable effects on glucose and lipid metabolism, inflammation, and oxidative stress which are the pivotal pathophysiological pathways in NAFLD. Naringenin is a citrus-derived flavonoid with a broad spectrum of potential biological effects including anti-inflammatory and antioxidant properties, which may exert protective effects against NAFLD. The present clinical trial aims to examine the efficacy of naringenin supplementation on plasma adiponectin and neurogulin-4 (NRG-4) concentrations, metabolic parameters, and liver function indices in overweight/obese patients with NAFLD. METHODS AND ANALYSIS: This is a double-blind, randomized, placebo-controlled clinical study that will investigate the impacts of naringenin supplementation in overweight/obese patients with NAFLD. Liver ultrasonography will be applied to diagnose NAFLD. Forty-four eligible overweight/obese subjects with NAFLD will be selected and randomly assigned to receive naringenin capsules or identical placebo (each capsule contains 100 mg of naringenin or cellulose), twice daily for 4 weeks. Participants will be asked to remain on their usual diet and physical activity. Safety of naringenin supplementation was confirmed by the study pharmacist. The primary outcome of this study is changes in adiponectin circulating levels. The secondary outcomes include changes in NRG-4 levels, liver function indices, metabolic parameters, body weight, body mass index (BMI), waist circumference (WC), blood pressure, and hematological parameters. Statistical analysis will be conducted using the SPSS software (version 25), and P value less than 0.05 will be regarded as statistically significant. DISCUSSION: We hypothesize that naringenin administration may be useful for treating NAFLD by modulating energy balance, glucose and lipid metabolism, oxidative stress, and inflammation through different mechanisms. The current trial will exhibit the effects of naringenin, whether negative or positive, on NAFLD status. ETHICAL ASPECTS: The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICNE.REC.1399.439). TRIAL REGISTRATION: Iranian Registry of Clinical Trials IRCT201311250155336N12 . Registered on 6 June 2020.

Effect of Collagen Hydrolysate and Fish Oil on High-Sensitivity C-Reactive Protein and Glucose Homeostasis in Patients with severe Burn; a Randomized Clinical Trial.

INTRODUCTION: Collagen and omega-3 fatty acids (FAs) are suggested to have anti-inflammatory, anti-oxidant, and insulin-sensitizing properties. The aim of this study was to investigate the effect of collagen hydrolysate and omega-3 FAs on inflammation and insulin resistance in patients with major burns. METHODS: In this double-blind randomized clinical trial, 66 patients with 20-45% burns were assigned to either of the three groups of collagen (40 gr/d), collagen (40 gr/d) plus fish oil (10 ml/d), or control. High-sensitivity C-reactive protein (hs-CRP), fasting blood glucose (FBG) and insulin concentrations, and homeostatic model assessment for insulin resistance (HOMA-IR) were assessed at baseline, as well as end of weeks two and three. RESULTS: Based on post-hoc analyses, hs-CRP levels were significantly lower in the collagen (p=0.026) and collagen+omega-3 (p=0.044) groups compared to the control group, at week three. However, pre- to post- (week three) changes of hs-CRP were significantly higher only in the collagen+omega-3 group compared to the control group (173.2 vs. 103.7 mg/l, p=0.024). After three weeks of the intervention, insulin (11.3 and 11.9 vs. 22.8 µIU/ml) and HOMA-IR (2.9 and 2.8 vs. 7.9) values seemed to be clinically, but not statistically, lower in both intervention groups compared to the control group. Pre- to post- (week three) values of FBG decreased significantly in the collagen (p=0.002) and collagen+omega-3 (p=0.036) groups. Insulin (p=0.008) and HOMA-IR (p=0.001) decreased significantly only in the collagen+omega-3 group at week three compared to the baseline. CONCLUSIONS: Supplementation with collagen hydrolysate and omega-3 FAs can improve hs-CRP concentration and probably insulin resistance in patients with severe burns. Omega-3 FAs had additional effects on modulating inflammation. Larger clinical trials are needed to confirm the current findings especially in terms of glucose homeostasis.

Association of overweight and obesity with the prevalence and incidence of pressure ulcers: A systematic review and meta-analysis.

BACKGROUND & AIM: Pressure ulcers challenge the health status, complicate medical conditions, and affect quality of life. The aim of this systematic review and meta-analysis was to investigate the role of obesity and body weight status, as potentially modifiable risk factors, in the incidence and prevalence of pressure ulcers. METHODS: A systematic search of observational studies was performed to assess documents published between January 1990 and December 2019 in PubMed and Scopus. Finally, 17 articles with total sample size of 2228724 in the prevalence and 218178 in the incidence study were included in the meta-analysis. RESULTS: The pooled data analysis showed no significant effect of obesity on odds of pressure ulcers' prevalence (OR 0.91, 95% CI 0.65 to 1.27, P = 0.579, I2 = 84.8%) or incidence (OR 0.97, 95% CI 0.56 to 1.66, P = 0.905, I2 = 89.8%) compared with non-obese individuals. Overweight was associated with significantly lower odds of prevalence of pressure ulcers compared to non-overweight individuals (OR 0.54, 95% CI 0.33 to 0.88, P = 0.014, I2 = 90.2%). The subgroup analyses showed significantly higher odds of prevalence (OR 2.38, 95% CI 1.72 to 3.29, P < 0.001, I2 = 63.4%) and incidence (OR 2.28, 95% CI 1.77 to 2.94, P < 0.001, I2 = 27.9%) of pressure ulcers in the underweight compared to normal weight groups. Pooled data analyses showed significantly lower odds of prevalence (OR 0.6, 95% CI 0.37 to 0.96, P = 0.034, I2 = 82%) and incidence (OR 0.72, 95% CI 0.53 to 0.98, P = 0.039, I2 = 67.1%) of pressure ulcers in the overweight than normal weight individuals. The findings showed no significant differences in the odds of prevalence or incidence of pressure ulcers in the obese and morbidly obese compared to normal weight individuals. CONCLUSION: This systematic review and meta-analysis showed no significant effect of obesity or morbid obesity on the odds of pressure ulcers. Additionally, overweight was associated with lower odds of pressure ulcers while underweight significantly increased the odds of pressure injuries.

Consumption of Dietary Fiber in Relation to Psychological Disorders in Adults.

Background: Previous observational studies suggested a relationship between dietary fiber consumption and mental health, but the findings were conflicting. We evaluated the link between dietary fiber intake and prevalence of depression, anxiety, and psychological distress among a large population of Iranian adults. Methods: A cross-sectional study among 3,362 Iranian adults working in 50 health centers was done. Data of dietary intakes were collected through a validated semiquantitative dish-based 106-item food frequency questionnaire (FFQ). Anxiety, depression, and psychological distress were defined based on the Iranian validated version of Hospital Anxiety and Depression Scale (HADS) and General Health Questionnaire (GHQ). Results: After adjustment for potential confounders, participants in the top quartile of total dietary fiber intake had a 33% and 29% lower risk of anxiety and high psychological distress [odds ratio (OR): 0.67; 95% CI: 0.48, 0.95 and OR: 0.71; 95% CI: 0.53, 0.94, respectively] compared to the bottom quartile of intake. The highest total dietary fiber intake was also inversely related to a lower risk of depression in women (OR: 0.63; 95% CI: 0.45, 0.88) but not in men. Among overweight or obese participants, higher intake of dietary fiber was related to a decreased risk of high psychological distress (OR: 0.52; 95% CI: 0.34, 0.79). A high level of dietary fiber intake was related to a lower risk of anxiety in normal-weight individuals (OR: 0.50; 95% CI: 0.31, 0.80). Conclusion: Significant inverse associations between total dietary fiber intake with anxiety and high psychological distress were found in Iranian adults. More consumption of dietary fiber was also related to reduced odds of depression in women. More investigations with prospective nature are needed to affirm these findings.

Association between the dietary inflammatory index and obesity in otherwise healthy adults: Role of age and sex.

AIM: The dietary inflammatory index (DII® ) can estimate the overall inflammatory potential of diet. This study aimed to assess the association between DII score and other diet quality parameters with weight status among normal weight, overweight and obese otherwise healthy adults. METHODS: This retrospective observational study investigated DII, energy-adjusted DII (E-DIITM ), dietary energy density (DED) and mean adequacy ratio (MAR) scores, based on a valid 168-item food frequency questionnaire, in 100 normal weight, 100 overweight and 100 obese healthy adults (age > 18yr). RESULTS: Normal-weight participants had higher DII scores than obese participants (mean difference (MD): 0.67, 95% confidence interval (CI): 0.004 - 1.33, P = .048). Body mass index (BMI) had an effect on DII score after adjusting for age (P = .03). A statistically significant interaction was observed between BMI and age on E-DII (P = .03) and MAR (P = .004). E-DII scores were lower (more anti-inflammatory) and MAR was higher with increasing age in the obese compared with normal-weight participants. Additionally, male participants had higher DII (MD: -0.53, 95% CI: -0.97 - -0.09, P = .02), E-DII (MD: -0.76, 95% CI: -1.12 - -0.35, P < .001), DED (MD: -0.09, 95% CI: -0.15 - -0.03, P = .004) and lower MAR (MD: 0.04, 95% CI: 0.02 - 0.06, P = .001), after adjusting for BMI. Obesity (Adjusted odds ratio (AOR) = 0.48, 95% CI: 0.26 - 0.91, P = .02) and DED (AOR =5.81, 95% CI: 2.28 - 14.81, P < .001) were the most important factors associated with high DII. CONCLUSIONS: This study showed that having a normal body weight is not necessarily indicative of less inflammatory potential of diet and better diet quality. Male sex and increasing age were important determinants of diet quality across BMI subgroups.

Effects of curcuminoids on inflammatory and oxidative stress biomarkers and clinical outcomes in critically ill patients: A randomized double-blind placebo-controlled trial.

Experimental studies have suggested the beneficial effects of curcuminoids as natural polyphenols against traumatic brain injury (TBI). The aim of this study was to investigate the effects of supplementation with curcuminoids on inflammatory and oxidative stress biomarkers, clinical outcomes and nutritional status in critically ill patients with TBI. A total of 62 ICU-admitted adult patients with TBI were randomly allocated to receive either a daily dose of 500 mg curcuminoids or matched placebo via enteral nutrition for 7 consecutive days based on stratified block randomization by age and sex. Inflammatory and oxidative stress as well as clinical outcomes and nutritional status of the patients were measured at baseline and at the end of the study. There were no overall group effects regarding to all dependent variables. Compared with baseline, serum levels of IL-6, TNF-α, MCP-1 and CRP were significantly reduced in patients receiving curcuminoids (p < .05) without any significant changes in placebo group; however, changes in the activities of GPx and SOD in serum were not significant between two groups. Moreover, APACHEII and NUTRIC score were significantly improved following curcuminoids consumption in comparison with placebo (p < .05). The findings of this study suggest that short-term supplementation with curcuminoids may have beneficial effects on inflammation, clinical outcomes and nutritional status of critically ill patients with TBI.