Improving Glucose Homeostasis after Parathyroidectomy for Normocalcemic Primary Hyperparathyroidism with Co-Existing Prediabetes

We have previously described increased fasting plasma glucose levels in patients with normocalcemic primary hyperparathyroidism (NPHPT) and co-existing prediabetes, compared to prediabetes per se. This study evaluated the effect of parathyroidectomy (PTx) (Group A), versus conservative follow-up (Group B), in a small cohort of patients with co-existing NPHPT and prediabetes. Sixteen patients were categorized in each group. Glycemic parameters (levels of fasting glucose (fGlu), glycosylated hemoglobin (HbA1c), and fasting insulin (fIns)), the homeostasis model assessment for estimating insulin secretion (HOMA-B) and resistance (HOMA-IR), and a 75-g oral glucose tolerance test were evaluated at baseline and after 32 weeks for both groups. Measurements at baseline were not significantly different between Groups A and B, respectively: fGlu (119.4 ± 2.8 vs. 118.2 ± 1.8 mg/dL, p = 0.451), HbA_1c (5.84 ± 0.3 %vs. 5.86 ± 0.4%, p = 0.411), HOMA-IR (3.1 ± 1.2 vs. 2.9 ± 0.2, p = 0.213), HOMA-B (112.9 ± 31.8 vs. 116.9 ± 21.0%, p = 0.312), fIns (11.0 ± 2.3 vs. 12.8 ± 1.4 μIU/mL, p = 0.731), and 2-h post-load glucose concentrations (163.2 ± 3.2 vs. 167.2 ± 3.2 mg/dL, p = 0.371). fGlu levels demonstrated a positive correlation with PTH concentrations for both groups (Group A, rho = 0.374, p = 0.005, and Group B, rho = 0.359, p = 0.008). At the end of follow-up, Group A demonstrated significant improvements after PTx compared to the baseline: fGlu ((119.4 ± 2.8 vs. 111.2 ± 1.9 mg/dL, p = 0.021) (−8.2 ± 0.6 mg/dL)), and 2-h post-load glucose concentrations ((163.2 ± 3.2 vs. 144.4 ± 3.2 mg/dL, p = 0.041), (−18.8 ± 0.3 mg/dL)). For Group B, results demonstrated non-significant differences: fGlu ((118.2 ± 1.8 vs. 117.6 ± 2.3 mg/dL, p = 0.031), (−0.6 ± 0.2 mg/dL)), and 2-h post-load glucose concentrations ((167.2 ± 2.7 vs. 176.2 ± 3.2 mg/dL, p = 0.781), (+9.0 ± 0.8 mg/dL)). We conclude that PTx for individuals with NPHPT and prediabetes may improve their glucose homeostasis when compared with conservative follow-up, after 8 months of follow-up.     

Gestational Diabetes Mellitus Is Associated with Differences in Human Milk Hormone and Cytokine Concentrations in a Fully Breastfeeding United States Cohort

It is unclear whether gestational diabetes mellitus (GDM) alters breast milk composition. We prospectively examined associations of GDM status with concentrations of six potentially bioactive elements (glucose, insulin, C-reactive protein (CRP), interleukin-6 (IL-6), leptin, and adiponectin) in human milk. These were measured at both 1 and 3 months postpartum in 189 fully breastfeeding women. Mixed-effects linear regression assessed GDM status-related differences in these milk bioactives, adjusting for demographics, maternal factors, and diet. At 1 and 3 months postpartum, milk CRP was higher (1.46 ± 0.31 ng/mL; p < 0.001 and 1.69 ± 0.31 ng/mL; p < 0.001) in women with GDM than in women without GDM, whereas milk glucose (−5.23 ± 2.22 mg/dL; p = 0.02 and −5.70 ± 2.22; p = 0.01) and milk insulin (−0.38 ± 0.17 μIU/mL; p = 0.03 and −0.53 ± 0.17; p = 0.003) were lower in women with GDM. These significant associations remained similar after additional adjustment for maternal weight status and its changes. No difference was found for milk IL-6, leptin, and adiponectin. There was no evidence of association between these milk bioactive compounds and 1 h non-fasting oral glucose challenge serum glucose in the women without GDM. This prospective study provides evidence that potentially bioactive elements of human milk composition are altered in women with GDM.     

Augmented Renal Clearance Following Traumatic Injury in Critically Ill Patients Requiring Nutrition Therapy

The intent of this study was to ascertain the prevalence of augmented renal clearance (ARC) in patients with traumatic injuries who require nutrition therapy and identify factors associated with ARC. Adult patients admitted to the trauma intensive care unit from January 2015 to September 2016 who received enteral or parenteral nutrition therapy and had a 24 h urine collection within 4 to 14 days after injury were retrospectively evaluated. Patients with a serum creatinine concentration > 1.5 mg/dL, required dialysis, or had an incomplete urine collection were excluded. ARC was defined as a measured creatinine clearance > 149 mL/min/1.73 m². Two hundred and three patients were evaluated. One hundred and two (50%) exhibited ARC. A greater proportion of patients with ARC were male (86% vs. 67%; p = 0.004), had traumatic brain injury (33% vs. 9%; p = 0.001), a higher injury severity score (30 ± 11 vs. 26 ± 12; p = 0.015), were younger (36 ± 15 vs. 54 ± 17 years; p = 0.001), had a lower serum creatinine concentration (0.7 ± 2 vs. 0.9 ± 0.2 mg/dL; p = 0.001) and were more catabolic (nitrogen balance of −10.8 ± 13.0 vs. −6.2 ± 9.2 g/d; p = 0.004). The multivariate analysis revealed African American race and protein intake were also associated with ARC. Half of critically ill patients with traumatic injuries experience ARC. Patients with multiple risk factors for ARC should be closely evaluated for dosing of renally-eliminated electrolytes, nutrients, and medications.     

The Impact of a High-Carbohydrate/Low Fat vs. Low-Carbohydrate Diet on Performance and Body Composition in Physically Active Adults: A Cross-Over Controlled Trial

Background: Recently, high-carbohydrate or low-carbohydrate (HC/LC) diets have gained substantial popularity, speculated to improve physical performance in athletes; however, the effects of short-term changes of the aforementioned nutritional interventions remain largely unclear. Methods: The present study investigated the impact of a three-week period of HC/low-fat (HC) diet followed by a three-week wash-out-phase and subsequent LC diet on the parameters of physical capacity assessed via cardiopulmonary exercise testing, body composition via bioimpedance analysis and blood profiles, which were assessed after each of the respective diet periods. Twenty-four physically active adults (14 females, age 25.8 ± 3.7 years, body mass index 22.1 ± 2.2 kg/m²), of which six participants served as a control group, were enrolled in the study. Results: After three weeks of each diet, VO_2peak was comparable following both interventions (46.8 ± 6.7 (HC) vs. 47.2 ± 6.7 mL/kg/min (LC; p = 0.58)) while a significantly higher peak performance (251 ± 43 W (HC) vs. 240 ± 45 W (LC); (p = 0.0001), longer time to exhaustion (14.5 ± 2.4 min (HC) vs. 14.1 ± 2.4 min (LC); p = 0.002) and greater Watt/kg performance (4.1 ± 0.5 W/kg (HC) vs. 3.9 ± 0.5 W/kg (LC); p = 0.003) was demonstrated after the HC diet. In both trial arms, a significant reduction in body mass (65.2 ± 11.2 to 63.8 ± 11.8 kg (HC) vs. 64.8 ± 11.6 to 63.5 ± 11.3 kg (LC); both p < 0.0001) and fat mass (22.7% to 21.2%; (HC) vs. 22.3% to 20.6% (LC); both p < 0.0001) but not in lean body mass or skeletal muscle mass was shown when compared to baseline. Resting metabolic rate was not different within both groups (p > 0.05). Total cholesterol and LDL-cholesterol significantly decreased after the HC diet (97.9 ± 33.6 mg/dL at baseline to 78.2 ± 23.5 mg/dL; p = 0.02) while triglycerides significantly increased (76 ± 38 mg/dL at baseline to 104 ± 44 mg/dL; p = 0.005). Conclusion: A short-term HC and LC diet showed improvements in various performance parameters in favor of the HC diet. Some parameters of body composition significantly changed during both diets. The HC diet led to a significant reduction in total and LDL-cholesterol while triglycerides significantly increased.     

A 12-Week,Multicenter, Randomized,Double-Blind,Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.     

Effects of High and Low Protein Diets on Inflammatory Profiles in People with Morbid Obesity: A 3-Week Intervention Study

Nutritional interventions in morbidly obese individuals that effectively reverse a pro-inflammatory state and prevent obesity-associated medical complications are highly warranted. Our aim was to evaluate the effect of high (HP) or low (LP) protein diets on circulating immune-inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-a), interleukin-10 (IL-10), monocyte chemoattractant protein-1 (MCP-1), chemerin, omentin, leptin, total adiponectin, high molecular weight adiponectin, and fetuin-A. With this aim, 18 people with morbid obesity were matched into two hypocaloric groups: HP (30E% protein, n = 8) and LP (10E% protein, n = 10) for three weeks. Biomarkers were measured pre and post intervention and linear mixed-effects models were used to investigate differences. Consuming HP or LP diets resulted in reduced CRP (HP: −2.2 ± 1.0 mg/L, LP: −2.3 ± 0.9 mg/L) and chemerin (HP: −17.9 ± 8.6 ng/mL, LP: −20.0 ± 7.4 ng/mL), with no statistically significant differences by diet arm. Participants following the LP diet showed a more pronounced decrease in leptin (−19.2 ± 6.0 ng/mL) and IL-6 (−0.4 ± 0.1 pg/mL) and an increase in total adiponectin (1.6 ± 0.6 µg/mL). Changes were also observed for the remaining biomarkers to a smaller degree by the HP than the LP hypocaloric diet, suggesting that a LP hypocaloric diet modulates a wider range of immune inflammatory biomarkers in morbidly obese individuals.     

Circulating Adiponectin and Its Association with Metabolic Traits and Type 2 Diabetes: Gene-Diet Interactions Focusing on Selected Gene Variants and at the Genome-Wide Level in High-Cardiovascular Risk Mediterranean Subjects

Adiponectin is gaining renewed interest since, in addition to its possible protective role against insulin resistance and arteriosclerosis, recent studies suggest other additional favorable effects. However, the influence of gene-diet interactions on plasma adiponectin levels is still little understood. We analyzed the association between plasma adiponectin levels and various metabolic traits in a high-cardiovascular risk Mediterranean population, as well as the genetic effect of four candidate single-nucleotide polymorphisms (SNPs) in the adiponectin gene (ADIPOQ) and their interactions with the Mediterranean dietary pattern. Additionally, we explored, at the genome-wide level, the SNPs most associated with plasma adiponectin levels, as well as gene–diet interactions with the Mediterranean diet. In the 954 participants studied (aged 55–80 years), plasma adiponectin levels were strongly associated with plasma HDL-C concentrations (p = 6.6 × 10⁻³⁶) and inversely related to triglycerides (p = 4.7 × 10⁻¹⁸), fasting glucose (p = 3.5 × 10⁻¹⁶) and type 2 diabetes (p = 1.4 × 10⁻⁷). Of the four pre-selected ADIPOQ candidate SNPs, the one most associated with plasma adiponectin was the −11391G > A (rs17300539) promoter SNP (p = 7.2 × 10⁻⁵, in the multivariable adjusted model). No significant interactions with the Mediterranean diet pattern were observed for these SNPs. Additionally, in the exploratory genome-wide association study (GWAS), we found new SNPs associated with adiponectin concentrations at the suggestive genome-wide level (p < 1 × 10⁻⁵) for the whole population, including the lead SNP rs9738548 (intergenic) and rs11647294 in the VAT1L (Vesicle Amine Transport 1 Like) gene. We also found other promising SNPs on exploring different strata such as men, women, diabetics and non-diabetics (p = 3.5 × 10⁻⁸ for rs2850066). Similarly, we explored gene–Mediterranean diet interactions at the GWAS level and identified several SNPs with gene–diet interactions at p < 1 × 10⁻⁵. A remarkable gene–diet interaction was revealed for the rs2917570 SNP in the OPCML (Opioid Binding Protein/Cell Adhesion Molecule Like) gene, previously reported to be associated with adiponectin levels in some populations. Our results suggest that, in this high-cardiovascular risk Mediterranean population, and even though adiponectin is favorably associated with metabolic traits and lower type 2 diabetes, the gene variants more associated with adiponectin may be population-specific, and some suggestive gene–Mediterranean diet interactions were detected.     

Effect of Weight Loss by Low-Calorie Diet on Cardiovascular Health in Type 2 Diabetes: An Interventional Cohort Study

Cardiovascular disease (CVD) remains a major problem for people with type 2 diabetes (T2DM), and the leading cause of death worldwide. We aimed to determine cardiovascular benefits of weight loss with or without remission of diabetes, and to assess utility of plasma biomarkers. 29 people with T2DM were studied at baseline and after dietary weight loss. Change in plasma adipokines and lipid related markers was examined in relation to weight loss, diabetes remission, 10-year cardiovascular risk (QRISK), and duration of diabetes. QRISK decreased markedly after weight loss (18.9 ± 2.2 to 11.2 ± 1.6%, p < 0.0001) in both responders and non-responders, but non-responders remained at higher risk (15.0 ± 2.0 vs. 5.8 ± 1.6%, p < 0.0001). At baseline, plasma GDF-15 was higher in longer diabetes duration (1.19 ± 0.14 vs. 0.82 ± 0.09 ng/mL, p = 0.034), as was the QRISK (22.8 ± 2.6 vs. 15.3 ± 3.4%, p = 0.031). Leptin, GDF-15 and FGF-21 decreased whereases adiponectin increased after weight loss in responders and non-responders. However, the level of FGF-21 remained higher in non-responders (0.58 [0.28–0.71] vs. 0.25 [0.15–0.42] ng/mL, p = 0.007). QRISK change correlated with change in plasma VLDL1-TG (r = 0.489, p = 0.007). There was a positive correlation between rise in HDL cholesterol and the decrease in leptin (r = 0.57, p = 0.001), or rise in adiponectin (r = 0.58, p = 0.001) levels. In conclusion, weight loss markedly decreases cardiometabolic risk particularly when remission of diabetes is achieved. Leptin, adiponectin, GDF-15 and FGF-21 changes were related to weight loss not remission of diabetes. Normalization of 10-year cardiovascular risk and heart age is possible after substantial dietary weight loss and remission of T2DM.     

Acute Metabolic Responses to Glucose and Fructose Supplementation in Healthy Individuals: A Double-Blind Randomized Crossover Placebo-Controlled Trial

The aim of this study was to investigate the impact of glucose (Glu), fructose (Fru), glucose and fructose (GluFru) and sucralose on blood glucose response in healthy individuals. Fifteen healthy individuals (five females, age of 25.4 ± 2.5 years, BMI of 23.7 ± 1.7 kg/m² with a body mass (BM) of 76.3 ± 12.3 kg) participated in this double-blind randomized crossover placebo-controlled trial. Participants received a mixture of 300 mL of water with 1 g/kg BM of Glu, 1 g/kg BM of Fru, 0.5 g/kg BM of GluFru (each), and 0.2 g sucralose as a placebo. Peak BG values Glu were reached after 40 ± 13 min (peak BG: 141 ± 20 mg/dL), for Fru after 36 ± 22 min (peak BG: 98 ± 7 mg/dL), for GluFru after 29 ± 8 min (BG 128 ± 18 mg/dL), and sucralose after 34 ± 27 min (peak BG: 83 ± 5 mg/dL). Significant differences regarding the time until peak BG were found only between Glu and GluFru supplementation (p = 0.02). Peak blood glucose levels were significantly lower following the ingestion of Fru compared to the supplementation of Glu and GluFru (p < 0.0001) while Glu and GluFru supplementation showed no difference in peak values (p = 0.23). All conditions led to a significantly higher peak BG value compared to sucralose (p < 0.0001). Blood lactate increased in Glu (p = 0.002), Fru and GluFru (both p < 0.0001), whereas sucralose did not increase compared to the baseline (p = 0.051). Insulin levels were significantly higher in all conditions at peak compared to sucralose (p < 0.0001). The findings of this study prove the feasibility of combined carbohydrate supplementations for many applications in diabetic or healthy exercise cohorts.     

Efficacy and Safety of Armolipid Plus®: An Updated PRISMA Compliant Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials

Armolipid Plus^® is a multi-constituent nutraceutical that claims to improve lipid profiles. The aim of this PRISMA compliant systematic review and meta-analysis was to globally evaluate the efficacy and safety of Armolipid Plus^® on the basis of the available randomized, blinded, controlled clinical trials (RCTs). A systematic literature search in several databases was conducted in order to identify RCTs assessing the efficacy and safety of dietary supplementation with Armolipid Plus^®. Two review authors independently identified 12 eligible studies (1050 included subjects overall) and extracted data on study characteristics, methods, and outcomes. Meta-analysis of the data suggested that dietary supplementation with Armolipid Plus^® exerted a significant effect on body mass index (mean difference (MD) = −0.25 kg/m², p = 0.008) and serum levels of total cholesterol (MD = −25.07 mg/dL, p < 0.001), triglycerides (MD = −11.47 mg/dL, p < 0.001), high-density lipoprotein cholesterol (MD = 1.84 mg/dL, p < 0.001), low-density lipoprotein cholesterol (MD = −26.67 mg/dL, p < 0.001), high sensitivity C reactive protein (hs-CRP, MD = −0.61 mg/L, p = 0.022), and fasting glucose (MD = −3.52 mg/dL, p < 0.001). Armolipid Plus^® was well tolerated. This meta-analysis demonstrates that dietary supplementation with Armolipid Plus^® is associated with clinically meaningful improvements in serum lipids, glucose, and hs-CRP. These changes are consistent with improved cardiometabolic health.     

Fat-Soluble Vitamin Supplementation Using Liposomes,Cyclodextrins, or Medium-Chain Triglycerides in Cystic Fibrosis: A Randomized Controlled Trial

Fat-soluble vitamin deficiency remains a challenge in cystic fibrosis (CF), chronic pancreatitis, and biliary atresia. Liposomes and cyclodextrins can enhance their bioavailability, thus this multi-center randomized placebo-controlled trial compared three-month supplementation of fat-soluble vitamins in the form of liposomes or cyclodextrins to medium-chain triglycerides (MCT) in pancreatic-insufficient CF patients. The daily doses were as follows: 2000 IU of retinyl palmitate, 4000 IU of vitamin D3, 200 IU of RRR-α-tocopherol, and 200 µg of vitamin K2 as menaquinone-7, with vitamin E given in soybean oil instead of liposomes. All participants received 4 mg of β-carotene and 1.07 mg of vitamin K1 to ensure compliance with the guidelines. The primary outcome was the change from the baseline of all-trans-retinol and 25-hydroxyvitamin D3 concentrations and the percentage of undercarboxylated osteocalcin. Out of 75 randomized patients (n = 28 liposomes, n = 22 cyclodextrins, and n = 25 MCT), 67 completed the trial (89%; n = 26 liposomes, n = 18 cyclodextrins, and n = 23 MCT) and had a median age of 22 years (IQR 19–28), body mass index of 20.6 kg/m² [18.4–22.0], and forced expiratory volume in 1 s of 65% (44–84%). The liposomal formulation of vitamin A was associated with the improved evolution of serum all-trans-retinol compared to the control (median +1.7 ng/mL (IQR −44.3–86.1) vs. −38.8 ng/mL (−71.2–6.8), p = 0.028). Cyclodextrins enhanced the bioavailability of vitamin D3 (+9.0 ng/mL (1.0–17.0) vs. +3.0 ng/mL (−4.0–7.0), p = 0.012) and vitamin E (+4.34 µg/mL (0.33–6.52) vs. −0.34 µg/mL (−1.71–2.15), p = 0.010). Liposomes may augment the bioavailability of vitamin A and cyclodextrins may strengthen the supplementation of vitamins D3 and E relative to MCT in pancreatic-insufficient CF but further studies are required to assess liposomal vitamin E (German Clinical Trial Register number DRKS00014295, funded from EU and Norsa Pharma).     

Cardiovascular Risk and Endothelial Dysfunction in Primary Sjogren Syndrome Is Related to the Disease Activity

The aim of our study was to evaluate if endothelial-dysfunction (ED) occurs in patients with primary Sjogren syndrome (pSS) and whether it is associated with the disease characteristics and activity. A total of 46 patients with pSS and 30 controls, without known cardiovascular disease, were enrolled in this study. A flow-mediated-dilation (FMD) of the brachial artery, plasma concentrations of the nitric oxide (NO) metabolic pathway (ADMA, L-arginine, SDMA, cGMP), and markers of endothelial inflammatory function (PAI-1, sE-selectin) and angiogenesis (angiostatin, VEGF) were analyzed. The FMD was significantly lower in pSS patients (7.56 ± 3.08 vs. 10.91 ± 1.02%, p = 0.043) and positively correlated with the Ro/SS-A-antibodies (r = 0.34, p = 0.03), pulmonary involvement (r = 0.52, p = 0.001) and inversely with ADMA (r = −0.35, p = 0.04). Plasma ADMA, L-arginine and angiostatin levels were significantly higher in pSS patients (0.39 ± 0.08 vs. 0.36 ± 0.06 µmol/L, p = 0.05; 29.07 ± 6.7 vs. 25.4 ± 5.23 µmol/L, p = 0.01; 152.25 ± 60.99 vs. 120.07 ± 38.7 pg/mL, p = 0.0, respectively). ADMA was associated with ESSDAI (r = 0.33, p = 0.02), SCORE (r = 0.57, p = 0.00003) and focus score (r = 0.38, p = 0.04). In the multiple regression analysis, the ESSDAI was significantly and independently associated with plasma ADMA levels (β = 0.24, p = 0.04). Moreover, plasma cGMP concentrations were negatively correlated with the disease duration (r = −0.31, p = 0.03). Endothelial function is impaired in patients with pSS and associated with the measures of disease activity, which supports the key-role of inflammation in developing and maintaining accelerated atherosclerosis.     

Augmented Renal Clearance,Muscle Catabolism and Urinary Nitrogen Loss: Implications for Nutritional Support in Critically Ill Trauma Patients

The main objective of this pilot study was to determine the association between augmented renal clearance (ARC), urinary nitrogen loss and muscle wasting in critically ill trauma patients. We conducted a retrospective analysis of a local database in 162 critically ill trauma patients without chronic renal dysfunction. Nutritional-related parameters and 24 h urinary biochemical analyses were prospectively collected and averaged over the first ten days after admission. Augmented renal clearance was defined by a mean creatinine clearance (CL_CR) > 130 mL/min/1.73 m². The main outcome was the cumulated nitrogen balance at day 10. The secondary outcome was the variation of muscle psoas cross-sectional area (ΔCSA) calculated in the subgroup of patients who underwent at least two abdominal CT scans during the ICU length of stay. Overall, there was a significant correlation between mean CL_CR and mean urinary nitrogen loss (normalized coefficient: 0.47 ± 0.07, p < 0.0001). ARC was associated with a significantly higher urinary nitrogen loss (17 ± 5 vs. 14 ± 4 g/day, p < 0.0001) and a lower nitrogen balance (−6 ± 5 vs. −4 ± 5 g/day, p = 0.0002), without difference regarding the mean protein intake (0.7 ± 0.2 vs. 0.7 ± 0.3 g/kg/day, p = 0.260). In the subgroup of patients who underwent a second abdominal CT scan (N = 47), both ΔCSA and %ΔCSA were higher in ARC patients (−33 [−41; −25] vs. −15 [−29; −5] mm²/day, p = 0.010 and −3 [−3; −2] vs. −1 [−3; −1] %/day, p = 0.008). Critically ill trauma patients with ARC are thus characterized by a lower nitrogen balance and increased muscle loss over the 10 first days after ICU admission. The interest of an increased protein intake (>1.5 g/kg/day) in such patients remains a matter of controversy and must be confirmed by further randomized trials.     

Hemp Seeds in Post-Arthroplasty Rehabilitation: A Pilot Clinical Study and an In Vitro Investigation

Osteoarthritis is a type of degenerative joint disease that results from the breakdown of joint cartilage and underlying bone. Due to their antioxidants and anti-inflammatory action, the phytochemical constituents of many vegetable varieties could represent a new frontier for the treatment of patients with Osteoarthritis and are still being explored. The aim of this pilot human study was to investigate the effects of pasta enriched with hemp seed flour on osteoarticular pain and bone formation markers in patients in post-arthroplasty rehabilitation. Another purpose was to evaluate the effect of hemp seed extract on bone metabolism, in vitro. A pilot, controlled, clinical study was conducted to verify the feasibility of pain symptom reduction in patients with Osteoarthritis undergoing arthroplasty surgery. We also investigated the effect of hemp seed extract on the Wnt/β-catenin and ERK1/2 pathways, alkaline phosphatase, RANKL, RUNX-2, osteocalcin, and COL1A on Saos-2. After 6 weeks, the consumption of hemp seed pasta led to greater pain relief compared to the regular pasta control group (−2.9 ± 1.3 cm vs. −1.3 ± 1.3 cm; p = 0.02). A significant reduction in serum BALP was observed in the participants consuming the hemp seed pasta compared to control group (−2.8 ± 3.2 µg/L vs. 1.1 ± 4.3 µg/L; p = 0.04). In the Saos-2 cell line, hemp seed extract also upregulated Wnt/β-catenin and Erk1/2 pathways (p = 0.02 and p = 0.03) and osteoblast differentiation markers (e.g., ALP, OC, RUNX2, and COL1A) and downregulated RANKL (p = 0.02), compared to the control. Our study demonstrated that hemp seed can improve pain symptoms in patients with osteoarthritis undergoing arthroplasty surgery and also improves bone metabolism both in humans and in vitro. However, more clinical studies are needed to confirm our preliminary findings.     

Effectiveness of Written Dietary Advice for Improving Blood Lipids in Primary Care Adults—A Pragmatic Randomized Controlled Trial (MYDICLIN)

Lifestyle management is the first line of treatment for moderately elevated blood lipids in healthy individuals. We investigated the effectiveness of providing food-based written advice for lowering low-density lipoprotein (LDL) cholesterol (intervention) or triglycerides (control) in a pragmatic randomized controlled trial with two parallel arms from 2018–2019 at a rural primary health care center. We sent feedback letters after 3 weeks and 6 months. Out of the 113 adult primary care patients randomized, 112 completed the study. There were no differences between the intervention and control groups for changes in LDL cholesterol after 3 weeks (mean ± standard deviation −0.21 ± 0.38 vs. −0.11 ± 0.34 mmol/L, p = 0.45) or 6 months (−0.05 ± 0.47 vs. 0.02 ± 0.41 mmol/L, p = 0.70) (primary outcome). Following the advice to consume plant sterols and turmeric was associated with a reduction in LDL cholesterol after 3 weeks. Following the advice to consume less carbohydrates was associated with reduced triglycerides. In the intervention arm, 14 individuals (25%) reduced their LDL cholesterol by ≥10% after three weeks. Their reduction was attenuated but maintained after six months (−7.1 ± 9.2% or −0.31 ± 0.38 mmol/L, p = 0.01 compared with baseline). They differed only in higher adherence to the advice regarding turmeric. In conclusion, this undemanding intervention had little effect on blood lipids for most individuals.     

A Phase IIb Randomized Controlled Trial Investigating the Effects of Tocotrienol-Rich Vitamin E on Diabetic Kidney Disease

Diabetic kidney disease (DKD) is a debilitating complication of diabetes, which develops in 40% of the diabetic population and is responsible for up to 50% of end-stage renal disease (ESRD). Tocotrienols have shown to be a potent antioxidant, anti-inflammatory, and antifibrotic agent in animal and clinical studies. This study evaluated the effects of 400 mg tocotrienol-rich vitamin E supplementation daily on 59 DKD patients over a 12-month period. Patients with stage 3 chronic kidney disease (CKD) or positive urine microalbuminuria (urine to albumin creatinine ratio; UACR > 20–200 mg/mmol) were recruited into a randomized, double-blind, placebo-controlled trial. Patients were randomized into either intervention group (n = 31) which received tocotrienol-rich vitamin E (Tocovid SupraBio^TM; Hovid Berhad, Ipoh, Malaysia) 400 mg daily or a placebo group which received placebo capsules (n = 28) for 12 months. HbA1c, renal parameters (i.e., serum creatinine, eGFR, and UACR), and serum biomarkers were collected at intervals of two months. Tocovid supplementation significantly reduced serum creatinine levels (MD: −4.28 ± 14.92 vs. 9.18 ± 24.96), p = 0.029, and significantly improved eGFR (MD: 1.90 ± 5.76 vs. −3.29 ± 9.24), p = 0.011 after eight months. Subgroup analysis of 37 patients with stage 3 CKD demonstrated persistent renoprotective effects over 12 months; Tocovid improved eGFR (MD: 4.83 ± 6.78 vs. −1.45 ± 9.18), p = 0.022 and serum creatinine (MD: −7.85(20.75) vs. 0.84(26.03), p = 0.042) but not UACR. After six months post washout, there was no improvement in serum creatinine and eGFR. There were no significant changes in the serum biomarkers, TGF-β1 and VEGF-A. Our findings verified the results from the pilot phase study where tocotrienol-rich vitamin E supplementation at two and three months improved kidney function as assessed by serum creatinine and eGFR but not UACR.     

Dietary Intake according to Gender and Education: A Twenty-Year Trend in a Swiss Adult Population

We assessed trends in dietary intake according to gender and education using repeated cross-sectional, population-based surveys conducted between 1993 and 2012 in Geneva, Switzerland (17,263 participants, 52.0 ± 10.6 years, 48% male). In 1993–1999, higher educated men had higher monounsaturated fatty acids (MUFA), carotene and vitamin D intakes than lower educated men, and the differences decreased in 2006–2012. In 1993–1999, higher educated women had higher fiber, iron, carotene, vitamin D and alcohol intakes than lower educated women, and the differences decreased in 2006–2012. Total energy, polyunsaturated fatty acids, retinol and alcohol intakes decreased, while mono/disaccharides, MUFA and carotene intake increased in both genders. Lower educated men had stronger decreases in saturated fatty acid (SFA) and calcium intakes than higher educated men: multivariate-adjusted slope and 95% confidence interval −0.11 (−0.15; −0.06) vs. −0.03 (−0.08; 0.02) g/day/year for SFA and −5.2 (−7.8; −2.7) vs. −1.03 (−3.8; 1.8) mg/day/year for calcium, p for interaction <0.05. Higher educated women had a greater decrease in iron intake than lower educated women: −0.03 (−0.04; −0.02) vs. −0.01 (−0.02; 0.00) mg/day/year, p for interaction = 0.002. We conclude that, in Switzerland, dietary intake evolved similarly between 1993 and 2012 in both educational groups. Educational differences present in 1993 persisted in 2012.     

Relationship between Carotenoids,Retinol, and Estradiol Levels in Older Women

Background. In vitro evidence suggests anti-estrogenic properties for retinol and carotenoids, supporting a chemo-preventive role of these phytochemicals in estrogen-dependent cancers. During aging there are significant reductions in retinol and carotenoid concentrations, whereas estradiol levels decline during menopause and progressively increase from the age of 65. We aimed to investigate the hypothesis of a potential relationship between circulating levels of retinol, carotenoids, and estradiol (E2) in a cohort of late post-menopausal women. Methods. We examined 512 women ≥ 65 years from the InCHIANTI study. Retinol, α-caroten, β-caroten, β-criptoxantin, lutein, zeaxanthin, and lycopene levels were assayed at enrollment (1998–2000) by High-Performance Liquid Chromatography. Estradiol and testosterone (T) levels were assessed by Radioimmunometry (RIA) and testosterone-to-estradiol ratio (T/E2), as a proxy of aromatase activity, was also calculated. General linear models adjusted for age (Model 1) and further adjusted for other confounders including Body Mass Index (BMI) BMI, smoking, intake of energy, lipids, and vitamin A; C-Reactive Protein, insulin, total cholesterol, liver function, and testosterone (Model 2) were used to investigate the relationship between retinol, carotenoids, and E2 levels. To address the independent relationship between carotenoids and E2 levels, factors significantly associated with E2 in Model 2 were also included in a fully adjusted Model 3. Results. After adjustment for age, α-carotene (β ± SE = −0.01 ± 0.004, p = 0.02) and β-carotene (β ± SE = −0.07 ± 0.02, p = 0.0007) were significantly and inversely associated with E2 levels. α-Carotene was also significantly and positively associated with T/E2 ratio (β ± SE = 0.07 ± 0.03, p = 0.01). After adjustment for other confounders (Model 2), the inverse relationship between α-carotene (β ± SE = −1.59 ± 0.61, p = 0.01), β-carotene (β ± SE = −0.29 ± 0.08, p = 0.0009), and E2 persisted whereas the relationship between α-carotene and T/E2 ratio was attenuated (β ± SE = 0.22 ± 0.12, p = 0.07). In a fully adjusted model (Model 3), only β-carotene (β ± SE = −0.05 ± 0.02, p = 0.03) was significantly and inversely associated with E2 levels independent of α-carotene. No association was found between retinol, total non-pro-vitamin A carotenoids, lutein, zeaxanthin, and lycopene, and E2 levels. Conclusions: In older women, β-carotene levels are independently and inversely associated with E2.     

Capsaicin Analogue Supplementation Does Not Improve 10 km Running Time-Trial Performance in Male Amateur Athletes: A Randomized,Crossover, Double-Blind and Placebo-Controlled Study

Background: To investigate the acute effects of a capsaicin analogue supplement on 10 km time-trial performance and physiological responses in amateur athletes. Methods: Twenty-one participants (age = 29.3 ± 5.5 years, weight 74.2 ± 11.3 kg, height 176.0 ± 0.0 cm, fat mass 12.7 ± 3.8%, V˙O_2max 62.7 ± 8.4 mL·k⁻¹·min⁻¹), completed two randomized, double-blind trials: capsaicin analogue condition (Capsiate (CAP) = 24 mg) or a placebo (PLA) condition. The participants consumed two doses of 12 mg of CAP or PLA capsule 45 min before and immediately at the start of each trial. The time required to complete 10 km, lactate concentration, maximum heart rate (HR_peak), and rating of perceived exertion (RPE) were recorded. Results: The 10 km time-trial performance (CAP = 45.07 ± 6.41 min vs. PLA = 45.13 ± 6.73, p = 0.828) was not statistically significantly different between conditions. No statistically significant differences between conditions were detected for lactate concentration (p = 0.507), HR_peak (p = 0.897) and RPE (p = 0.517). Conclusion: Two doses of a 12 mg Capsaicin analogue supplement did not improve performance and physiological responses in a 10 km running time-trial in amateur athletes.     

Association of Serum Phosphate with Low Handgrip Strength in Patients with Advanced Chronic Kidney Disease

Muscle wasting and hyperphosphatemia are becoming increasingly prevalent in patients who exhibit a progressive decline in kidney function. However, the association between serum phosphate (Pi) level and sarcopenia in advanced chronic kidney disease (CKD) patients remains unclear. We compared the serum Pi levels between advanced CKD patients with (n = 51) and those without sarcopenia indicators (n = 83). Low appendicular skeletal muscle mass index (ASMI), low handgrip strength, and low gait speed were defined per the standards of the Asian Working Group for Sarcopenia. Mean serum Pi level was significantly higher in advanced CKD patients with sarcopenia indicators than those without sarcopenia indicators (3.88 ± 0.86 vs. 3.54 ± 0.73 mg/dL; p = 0.016). Univariate analysis indicated that serum Pi was negatively correlated with ASMI, handgrip strength, and gait speed. Multivariable analysis revealed that serum Pi was significantly associated with handgrip strength (standardized β = −0.168; p = 0.022) and this association persisted even after adjustments for potential confounders. The optimal serum Pi cutoff for predicting low handgrip strength was 3.65 mg/dL, with a sensitivity of 82.1% and specificity of 56.6%. In summary, low handgrip strength is common in advanced CKD patients and serum Pi level is negatively associated with handgrip strength.