The wound healing effect of local leukocyte platelet-rich plasma after total hip arthroplasty: A randomized controlled trial.

Rapid wound closure is important after arthroplasty procedures to prevent postoperative complications. Platelets are rich in growth factors and leukocytes contribute to innate immunity. We hypothesized that topical leukocyte platelet-rich plasma (L-PRP) derived from the blood of patients would be beneficial to wound healing. In this randomized controlled trial, patients subjected to elective total hip arthroplasty (THA) were assigned by concealed allocation either L-PRP application onto the sutured fascia or no application (control) after the THA intervention. In addition, all patients received 1.5 g protein/kg, 5 g L-arginine, 500 mg vitamin C and 44 mg zinc daily over the 4-week postoperative period to obtain optimal nutrition. The primary endpoint was complete healing of the skin incision. The secondary endpoints were blood transfusions, length of hospital stay, pain and wound infections. Sixteen patients in the L-PRP group and 17 patients in the control group completed the trial. L-PRP treatment accelerated complete wound healing after 3 weeks (seven in the L-PRP group vs. zero in the control group, p = 0.003) and after 4 weeks (12 in the L-PRP group vs. six in the control group, p = 0.037). No postoperative superficial wound infections occurred within 4 weeks, and there were no significant differences in the other secondary outcomes. L-PRP generated in 10 sex-matched healthy volunteers revealed increased concentrations of platelets (5.8-fold) and leukocytes (2.3-fold) compared with those in whole blood. Furthermore, the concentration of keratinocyte mitogen epidermal growth factor in L-PRP (380 ± 130 pg/ml, mean ± SD) was higher (p < 0.001) than that in serum (130 ± 26 pg/ml). In conclusion, a single intraoperative local application of L-PRP promoted wound healing after THA, possibly mediated by EGF receptor agonists.

Multinutrient Supplementation Increases Collagen Synthesis during Early Wound Repair in a Randomized Controlled Trial in Patients with Inguinal Hernia.

BACKGROUND: Inguinal hernia disease is associated with an imbalanced collagen metabolism. Surgical stress has a negative impact on nutrients important for collagen synthesis. OBJECTIVE: We hypothesized that supplementation with a combination of nutrients would enhance collagen biosynthesis in inguinal hernia disease patients when undergoing hernia repair. METHODS: In this exploratory randomized controlled trial, 21 men (age: 55.2 ± 2.8 y; BMI: 25.0 ± 0.7 kg/m2) scheduled for Lichtenstein inguinal hernia repair were assigned to multinutrient supplementation (n = 10; multinutrient group) or no multinutrient supplementation (n = 11; control group). The multinutrient group received 14 g l-arginine, 14 g l-glutamine, 1250 mg vitamin C, and 55 mg zinc daily starting 14 d before surgery and ending 14 d after surgery. The multinutrient and control groups received high-quality protein to ensure a daily intake of 1.5 g protein/kg. Collagen biosynthesis was measured by the biomarkers type I procollagen propeptide (CICP), type III procollagen propeptide (PRO-C3), and type V procollagen propeptide (PRO-C5) in the sera on days -14, 0, and 1, and in the wound fluids on postoperative days 1 and 2. Compliance was recorded after the 28-d intervention period. RESULTS: Serum PRO-C5 concentrations decreased (P < 0.05) postoperatively in the control but not the multinutrient group. Neither CICP nor PRO-C3 serum concentrations differed significantly between the 2 groups. In wound fluid, the CICP concentrations increased (P < 0.05) from days 1 to 2 in the multinutrient group and were 49% higher (P = 0.10) than those in the control group on day 2. Wound fluid concentrations PRO-C3 and PRO-C5 showed no significant time or group differences. The 28-d compliance was similar (P = 0.27) in the 2 groups. CONCLUSION: Oral supplementation with arginine, glutamine, vitamin C, and zinc augment collagen synthesis during the first 2 d after inguinal hernia repair. This trial was registered at clinicaltrials.gov as NCT03221686.

The Effect of Special Diets on Weight and Nutritional Intake in Hematological Cancer Patients: A Randomized Study.

Major weight loss and taste changes are well documented in patients with hematological cancer during chemotherapy. We have previously documented, that such patients have preferences for much umami, a little sweet, sour and salt, and no bitter. We wanted to convert these results into real diets. Patients participated in two sensory pilot studies (n = 10), where dishes were tested for preferences before and after chemotherapy. From these results, four dishes were selected and tested on 32 patients in 30 days in a cross-over design. The diets resulted in a beneficial and statistically significant difference in weight development (p = 0.0008), with 1.2 ± 1.9 kg (+2%) in the intervention period and -2.8 ± 5.2 kg (-4%) in the control period. This difference persisted after sensitivity analysis (±10%) P = 0.005. However, the nutritional intake was still low in both periods, and the treatment with cytarabine turned out to be a major confounder as dosage was significantly higher in the control period.

Whole-Grain Rye and Wheat Affect Some Markers of Gut Health without Altering the Fecal Microbiota in Healthy Overweight Adults: A 6-Week Randomized Trial.

Background: Whole grains have shown potential for improving gut health, but evidence comparing different whole-grain types is lacking.Objective: We investigated whether whole-grain wheat (WGW) and whole-grain rye (WGR) improve gut health in different ways compared to refined wheat (RW), with the primary outcomes of microbiota composition and gastrointestinal (GI) symptoms.Methods: In a randomized parallel trial, 70 healthy adults (in means ± SDs; aged 51.0 ± 9.4 y, body mass index [BMI (in kg/m2)] 27.8 ± 1.9, 32:38 men:women) replaced cereal foods from their habitual diet with WGR, WGW, or RW (control). Before and after a 6-wk intervention, a spot stool sample was collected and analyzed for short-chain fatty acids and microbiota composition through the use of 16S ribosomal RNA gene-targeted high-throughput amplicon sequencing. GI symptoms and stool regularity were evaluated by questionnaires at baseline and after weeks 2, 4, and 6.Results: Intakes of whole grains were 145.2 ± 75.9, 124.2 ± 57.3, and 5.4 ± 3.2 g/d in the WGW, WGR, and RW groups, respectively. Gut microbiota composition was not affected by diet. The relative change in fecal butyrate decreased in the RW (-38%) group compared to the WGW (25%, P = 0.014) and WGR groups (-1%, P = 0.037). Other short-chain fatty acids were unaffected. Flatulence was more frequent following intake of WGW (OR: 2.06, 95% CI: 1.03, 4.17) and WGR (OR: 2.62, 95% CI: 1.35, 5.22) compared to RW, whereas bloating was less frequent following WGW (OR: 0.38, 95% CI: 0.18, 0.80) and WGR (OR: 0.34, 95% CI: 0.16, 0.72). Stool frequency increased following WGR but not WGW, compared to RW in weeks 2 (0.4 defecations/d, P = 0.049) and 4 (0.5 defecations/d, P = 0.043), but not in week 6. The WGW and WGR groups did not differ from each other in any of the variables tested.Conclusion: Regular consumption of WGR and WGW affected fecal butyrate concentration and gastrointestinal symptoms in healthy overweight adults, supporting the hypothesis that WGR and WGW can be included in the diet equally to maintain gut health. This trial was registered at clinicaltrials.gov as NCT02358122.

The Effect of Preoperative Oral Immunonutrition on Complications and Length of Hospital Stay After Elective Surgery for Pancreatic Cancer--A Randomized Controlled Trial.

Major gastrointestinal surgery is associated with immune suppression and a high risk of postoperative complications. The aim of this open, randomized controlled trial was to examine the effect of supplementary per oral immunonutrition (IN) seven days before surgery for pancreatic cancer (PC) on postoperative complications and length of hospital stay (LOS). Secondary outcomes were the changes in functional capability and body weight (BW). Consecutive patients referred for surgery for diagnosed or plausible PC were included. The patients in the intervention group received supplementary IN (Oral Impact®, Nestlé) to reach a goal of 1.5 g protein/kg BW. The control group continued their habitual diet. Complications and LOS were independently assessed by the surgical staff. Secondary outcomes were measured 10, 20, and 30 days postoperatively. Thirty-five patients were included, of whom 19 (54%) were allocated to the intervention group. The doses of IN ranged from 250 to 1000 ml per day and the median compliance was 100 (0-100%). Based on the principle of intention-to-treat, no significant differences were found between the groups. We conclude that the lack of effect could be due to the limited dosage of IN, and/or because only 40% of the patients were at nutritional risk.

Incidence and Risk Factors of Refeeding Syndrome in Head and Neck Cancer Patients-An Observational Study.

This study aimed to determine the incidence rates of refeeding phenomena (defined as a decline in p-phosphate) and refeeding syndrome (RFS; defined as development of clinical symptoms in addition to a decline in p-phosphate) in head and neck cancer patients, and to identify risk factors. Fifty-four head and neck cancer patients referred for surgery were included. Forty-six potential risk factors were registered at the baseline, and p-phosphate was measured at Days 2, 4, and 7. Eleven patients (20%) developed RFS, and twenty-eight (52%) developed refeeding phenomena. At baseline, these patients presented a higher prevalence of head and neck pain, eating difficulties, higher p-phosphate levels, lower p-transferrin levels, and, in men, lower b-hemoglobin levels. Patients who developed symptoms had a decline in p-phosphate ≥0.22 mmol/l. At baseline, these patients had higher p-phosphate levels, higher alcohol consumption, and lower p-transferrin and p-sodium levels, as well as a higher prevalence of eating difficulties, low handgrip strength (HGS), and a history of radiation therapy. The risk factors most strongly associated with the development of refeeding phenomena and RFS were pain, eating difficulties, low HGS, high alcohol intake, and previous radiation therapy.

Prediction of critical weight loss during radiation treatment in head and neck cancer patients is dependent on BMI.

PURPOSE: The aims of the present study were to explore pre-treatment predictors of weight loss during radiation treatment only in head and neck cancer (HNSCC) patients and investigate the weight loss in patients with or without a feeding tube. METHODS: Retrospectively, weight change during curative radiotherapy was investigated in 476 consecutive HNSCC patients. Independent predictors were identified using multivariate regression analysis with weight loss below or above 5 % as the primary dependent variable. RESULTS: Baseline BMI, tumor site, and stage predicted weight loss above 5 %. The odds of weight loss above 5 % in patients with BMI >25 were 3.00 ± 0.64 times higher compared with patients with BMI <25 (p < 0.0001). Patients with pharyngeal, oral cavity, or supraglottic tumors had 3.12 ± 0.80 times higher odds of weight loss above 5 % compared with glottic cancer patients (p < 0.0001), and the odds were 1.68 ± 0.40 times higher in stage III-IV patients compared with stage I-II patients (p = 0.03). Seperate analyses revealed that tumor site and stage only predicted weight loss in patients with BMI >25 but not in patients with BMI <25. Patients receiving a feeding tube weighed less than patients without (73.8 vs 78.3 kg) and feeding tube reduced, but did not prevent, weight loss which averaged 6.7 ± 4.7 kg (7.4 ± 4.7 %) compared with 4.7 ± 5.9 kg (5.5 ± 6.0 %) in patients without a feeding tube (P < 0.0001). CONCLUSION: Pre-treatment BMI, tumor site and stage predicted weight loss above 5 % in HNSCC patients during radiotherapy. BMI should be considered when analyzing weight loss in HNSCC patients receiving curative radiotherapy.

Historical Study (1986-2014): Improvements in Nutritional Status of Dialysis Patients.

OBJECTIVE: Malnutrition is common in dialysis patients and is associated with adverse clinical outcomes. Despite an increased focus on improved nutrition in dialysis patients, it is claimed that the prevalence of malnutrition in this group of patients has not changed during the last decades. Direct historical comparisons of the nutritional status of dialysis patients have never been published. To directly compare the nutritional status of past and current dialysis patients, we implemented the methodology of a study from 1986 on a population of dialysis patients in 2014. DESIGN: Historical study comparing results of two cross-sectional studies performed in 1986 and 2014. SETTING: We compared the nutritional status of hemodialysis (HD) and peritoneal dialysis (PD) patients attending the dialysis center at Roskilde Hospital, Denmark, in February to June 2014, with that of HD and PD patients treated at the dialysis center at Fredericia Hospital, Denmark, in April 1986. SUBJECTS: Maintenance PD and HD patients (n = 64 in 2014 and n = 48 in 1986). METHODS: We performed anthropometry (body weight, triceps skinfold, and midarm muscle circumferences [MAMCs]) and determined plasma transferrin. MAIN OUTCOME MEASURE: Relative body weight, triceps skinfold, MAMC, body mass index, and prevalence of protein-caloric malnutrition as defined in the original study from 1986. RESULTS: Average relative body weight, triceps skinfold, MAMC, and body mass index were significantly higher in 2014 compared with 1986. The prevalence of protein-caloric malnutrition was significantly lower in 2014 (18%) compared with 1986 (52%). CONCLUSIONS: The nutritional status of maintenance dialysis patients has improved during the last 3 decades. The reason for this improvement could not be identified in the present study, but the most likely contributors are the higher prevalence of obesity in the general population, less predialytic malnutrition, and an improved focus on nutrition in maintenance dialysis patients.

Effect of vitamin D on inflammatory and clinical outcomes in patients with rheumatoid arthritis: a systematic review and dose-response meta-analysis of randomized controlled trials.

CONTEXT: Rheumatoid arthritis is a chronic inflammatory disease that causes synovitis. Vitamin D deficiency is common in rheumatoid arthritis. OBJECTIVE: This systematic review and meta-analysis investigated whether vitamin D supplementation affects the inflammatory and clinical outcomes in patients with rheumatoid arthritis on the basis of randomized clinical trials. DATA SOURCES: A literature search was performed in the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, Embase, and Google Scholar for articles published until May 2022. DATA EXTRACTION: The studies were selected according to PRISMA guidelines, and the risk of bias was assessed for randomized controlled trials. DATA ANALYSIS: A random effects model was used to conduct a meta-analysis, and heterogeneity was assessed using the I2 statistic. Of 464 records, 11 studies were included from 3049 patients. Conclusion: Vitamin D supplementation did not significantly reduce C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), disease activity score in 28 joints (DAS28), or the health assessment questionnaire score; however, the response to supplementation was highly heterogeneous. The pooled analysis showed that vitamin D significantly reduced the pain-visual analogue scale (VAS) weighted mean difference (WMD = -1.30, 95% confidence interval [CI] [-2.34, -27], P = .01), DAS28-CRP (WMD = -.58, 95% CI [-.86, -.31], P < .0001), and DAS28-ESR (WMD = -.58, 95% CI [-.86, -.31], P = .0001). Subgroup analysis for vitamin D doses (>100 µg per day versus <100 µg per day) showed that the higher doses had a more significant effect on CRP than the lower doses (P < .05). CONCLUSIONS: There was no significant difference between the effect of 2 vitamin D doses on ESR and DAS28. To minimize the high heterogeneity among studies in this meta-analysis, other confounding factors such as baseline vitamin D, age, dietary vitamin D, time of year, sun exposure, drug interaction, effect dosage, and power of study should be examined.

Prevention of Taste Alterations in Patients with Cancer Receiving Paclitaxel- or Oxaliplatin-Based Chemotherapy-A Pilot Trial of Cannabidiol.

INTRODUCTION: Taste alteration is a common adverse effect of chemotherapy. This study aimed to investigate the effect of cannabidiol (CBD) on Lean Body Mass (LBM), and taste alterations during oxaliplatin- or paclitaxel-based chemotherapy. METHODS: LBM was estimated by bioelectrical impedance analysis (BIA), and taste perception was evaluated by a randomized sensory test of six samples: sweet, salt, and umami, all in weak and strong concentrations. Taste perceptions were scored on visual analog scales. Patients in the intervention group received oral CBD 300 mg/day for 8 days; patients in the control group did not. Patients were followed for three cycles of chemotherapy. RESULTS: Twenty-two/ten patients (intervention/control group) were eligible. No effects on LBM were demonstrated. At baseline, the control group was able to differentiate between weak and strong saltiness and weak and strong sweetness but lost this ability after three cycles of chemotherapy. At baseline, the intervention group was unable to differentiate between the concentrations but gained the ability to significantly differentiate between weak and strong sweetness (p = 0.03) and weak and strong saltiness (p = 0.04) after three cycles of chemotherapy and treatment with CBD. CONCLUSIONS: CBD may improve patients' ability to differentiate taste strengths during chemotherapy.

High-protein diet during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease.

INTRODUCTION: The prevalence of cachexia in patients with chronic obstructive pulmonary disease (COPD) is high and associated with reduced quality of life, increased mortality and morbidity. We aimed to test the effect of a high protein diet combined with exercise on fat-free mass (FFM), functional capacity, symptom burden and dyspnoea. METHODS: Outpatients with COPD and severe or very severe (GOLD grade III-IV) disease and malnutrition commencing pulmonary rehabilitation were randomised to a high-protein diet or standard care. FFM was measured by bio-impedance analysis (BIA), mid-upper arm circumference (MUAC) and mid-thigh circumference (MTC), peripheral muscle function by six-minute walking distance (6MWD) and handgrip strength (HGS), symptoms by the COPD Assessment Trial (CAT) and dyspnoea by the Medical Research Council dyspnoea scale and Borg scores; all at baseline and after 12 weeks. RESULTS: Ten out of 13 randomised patients completed the trial. The intervention group was superior to the control group with respect to 6MWD (97 ± 93 m, p = 0.04) at 12 weeks. No differences were observed between the groups in HGS, anthropometrics, symptom burden or dyspnoea. CONCLUSION: In patients with COPD attending rehabilitation, a high protein diet combined with physical exercise had a clinically relevant effect on walking distance. FUNDING: none. TRIAL REGISTRATION: NCT04888182.

Effects of Postdischarge High-Protein Oral Nutritional Supplements and Resistance Training in Malnourished Surgical Patients: A Pilot Randomized Controlled Trial.

The presence of malnutrition is increasingly becoming a postdischarge problem in surgical patients. We aimed to investigate whether oral nutritional supplements combined with resistance training could minimize skeletal muscle atrophy in surgical patients after discharge. This randomized controlled study was conducted at the Department of Surgery, National Hospital of Faroe Islands from 2018 to 2020. A total of 45 patients aged 37−74 years participated and were allocated to one of three groups: diet (DI; n = 13), exercise and diet (EX + DI; n = 16), or control (CON; n = 16). The intervention period lasted 8 weeks. The intervention groups received individual dietary counselling and a protein-rich oral nutritional supplement twice a day containing 22 g of protein/day. Patients in the EX + DI group were assigned to resistance training sessions. Patients in the CON group received standard care. The primary outcome was change in lean body mass (LBM). Secondary outcomes were change in body weight, handgrip strength, quality of life, surgery-related side effects, energy and protein intake, length of stay and one-year mortality. To estimate within-group changes, linear mixed models including group−time interactions as fixed effects and patients as random effects were fitted. Within-group change in LBM was 233, 813 and 78 g in the DI, EX + DI and CON groups, respectively, with no significant between-group difference (p > 0.05). Pain score declined more (p = 0.04) in the EX + DI group compared with the CON group. Body weight, handgrip strength, quality of life and surgery-related side effects did not differ between groups. At the end of study, mean cumulative weight change in the DI and EX + DI groups was 0.4% and 1.6%, respectively, whereas the CON group experienced a weight loss of −0.6%. No significant difference in primary outcome between groups was noted. However, our results indicate some benefits from exercise and nutrition for malnourished surgical patients.

Treatment of Vitamin K Deficiency in Hemodialysis Patients - A Pilot Study Comparing Menaquinone-7 Tablets and a Vitamin K Rich Diet.

Purpose: Vitamin K deficiency and hence a high level of plasma dephosphorylated undercarboxylated matrix Gla protein (dp-ucMGP) is frequent in patients on hemodialysis. This group is recommended to restrict their potassium intake which often leads to restriction of vitamin K rich foods. A menaquinone-7 (MK-7) supplement has been shown to decrease dp-ucMGP, but it has yet to be examined if a vitamin K rich diet could be equally effective. Patients and Methods: A prospective randomized crossover intervention trial with two arms; 6 weeks of 360 µg MK-7 tablet/day and 6 weeks of a vitamin K rich diet with a 3-week washout period in between. Participants were 10 patients in hemodialysis and the primary outcome measures were changes in dp-ucMGP, total MGP (tMGP), and undercarboxylated osteocalcin (ucOC). Furthermore, the level of potassium and phylloquinone in broccoli was determined after different durations of boiling. Results: During the MK-7 intervention the dp-ucMGP and ucOC decreased significantly compared to baseline (-0.42 [-0.93; -0.22] nmol/L (p=<0.01) and -1.85 [-2.91; -1.30] nmol/L (p<0.01)), while these were unchanged during the dietary intervention (0.03 [-0.64; 0.37] nmol/L (p=1.00) and 0.30 [-1.71; 1.41] nmol/L (p=0.77)). Between the two interventions there was a greater decrease in ucOC (p=0.02) during the MK-7 compared to the dietary period. No significant changes in the total MGP levels were found in any of the periods. The retention of potassium following boiling for 2 minutes and 8 minutes was 76% and 49%, respectively, while for phylloquinone the retention was 92%, and independent of duration of boiling. Conclusion: A daily MK-7 supplement for 6 weeks lowered dp-ucMGP and ucOC significantly, while a vitamin K rich diet was not able to induce any significant effect. Boiled broccoli maintains a reasonable content of phylloquinone while potassium is extracted and is a reasonable source of phylloquinone for patients on hemodialysis.

Factors associated with long-term mortality in acute pancreatitis.

BACKGROUND AND AIMS: Knowledge of the long-term prognosis of acute pancreatitis (AP) is limited. The aims were to investigate: (1) prognostic factors associated with long-term mortality in patients with AP; (2) whether or not the level of serum (S-)amylase at admission had an impact on the prognosis; (3) causes of death in these patients. METHODS: During 1977-1982, patients who were admitted to the five main hospitals in Copenhagen with a diagnosis of AP or chronic pancreatitis (CP) were included in a prospective cohort, the Copenhagen Pancreatitis Study (CPS); in 2008, they were followed up by linkage to the Danish Registries. The analyzed subcohort consisted of 352 patients with probable AP (n = 54) or definite AP (n = 298). RESULTS: Multivariate Cox regression analysis showed that significant factors associated with mortality were age, alcohol, and diabetes, whereas female gender, co-living and employment were associated with better survival. The S-amylase level had no impact on mortality. The most frequent causes of death were cardiovascular diseases, digestive diseases, and malignancies. CONCLUSIONS: Age, alcohol and diabetes had a significant impact on survival whereas the S-amylase level did not.

Individual nutritional intervention for prevention of readmission among geriatric patients-a randomized controlled pilot trial.

BACKGROUND: Approximately 20% of older people are readmitted to the hospital within 30 days of discharge. Even a short hospital stay decreases the ability to cope with the activities of daily living. The aims of this study were to (1) assess the feasibility of recruitment, (2) assess the acceptability of the intervention, and (3) investigate if an individual nutritional intervention could reduce the readmission rate of geriatric patients within 30 days of being discharged to their own homes. METHODS: The unblinded, randomized, controlled pilot trial includes geriatric patients discharged to their own homes. Forty patients were recruited from a medical ward and randomized to standard treatment (n = 19) or individualized nutritional intervention (n = 21). The intervention was dietary counseling and a nutrition plan before discharge, combined with two home visits performed by an educated nutritionist over a period of 4 weeks. Outcomes were readmission (primary), mortality, protein and energy intake, body weight, activity of daily living, handgrip strength, number of chair stands, and quality of life. Intention-to-treat analysis, per-protocol analysis, and post hoc analysis of readmissions were carried out. RESULTS: Recruitment was feasible, and there was high compliance to the intervention. There was no difference in readmission between the intervention group and control group 30 days after discharge (29% vs 11%). The individual nutritional intervention had a positive impact on achieving 75% of energy requirements at 30 days for the intervention group compared to the control group (93% vs 47%, p = 0.01). No other differences were found between the groups. CONCLUSION: The individual nutritional intervention did not prevent readmission among geriatric patients in this trial. Recruitment procedures functioned well, and the intervention was well accepted by the patients. TRIAL REGISTRATION: ClinicalTrial.gov, NCT03519139 . Retrospectively registered on 8 May 2018.

N-3 fatty acid EPA supplementation in cancer patients receiving abdominal radiotherapy - A randomised controlled trial.

BACKGROUND & AIMS: Malnutrition occurs frequently in patients with cancer during and after radiotherapy to the gastrointestinal (GI) and pelvic area and can lead to negative outcomes. N-3 fatty acids from fish, especially eicosapentaenoic acid (EPA) may possess anticachectic properties. The aim of this study was to investigate the effect of two nutritional interventions; dietary counselling and a daily oral nutritional supplement (ONS) containing 33.8 g of protein and 2.2 g EPA and 1.1 g docosahexaenoic acid (DHA) or standard care, including dietary counselling and protein supplementation when needed. METHODS: Outpatients commencing radiotherapy to the GI area were randomized to receive dietary counselling and daily supplementation over a 5-7-week period or standard care. Outcome parameters were measured at baseline (onset of radiotherapy), week 5, and 12 weeks after commencing radiotherapy, with one additional measurement of body weight at week 2. Quality of life (QoL) was measured using the EORTC QLQ-C30 questionnaire. Radiotherapy-related side effects were assessed using a questionnaire developed specifically for this study. Data from a historical control group collected in a previous observational study were included in this study to compare incidence of weight loss. RESULTS: In total, 30 patients were recruited to this study and 26 patients were enrolled and randomised. The rate of withdrawals was 7.7% at week 2, 15.4% at week 5, and 19.2% at week 12. In total, 22 patients completed the intervention. All the patients in the ONS-group and 85% in the control group experienced weight-loss. Using the intention to treat principle, there were no significant differences between groups in any of the outcomes. All patients experienced side effects. Five out of 11 patients consumed more than 75% of prescribed dose of the fish oil enriched oral nutritional supplement. Post hoc analysis showed that at week 2 the weight changed in high-compliant patients was +1.7% (1.0-2.6) compared with -0.7% (-2.8 to -0.1) in low compliant patients (p < 0,01). The results indicated a dose-response relationship, as correlation analysis recovered a significant positive correlation between weight change and compliance to the fish oil enriched nutritional supplement at both week 2 and 5 (p < 0.05 and p < 0.01, respectively), but not at week 12, indicating a dose-response relationship during radiotherapy but not after. The proportion of patients experiencing weight loss throughout the study period was higher in this study (84.2%) than in the historical control group (73%) (p<0.05%). CONCLUSION: This study showed no effect from dietary counselling and intended protein/fish-oil supplementation on weight loss, quality of life, and nutritional intake, micronutrient status in plasma or radiotherapy-related side effects compared to the control group. However, the compliance to the fish oil enriched oral nutritional supplement was low. Post hoc analysis of dose-response relations indicate a positive correlation between the compliance and the ability to reduce weight loss in cancer patients during radiotherapy treatment. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT04687124.

Danish patients with chronic pancreatitis have a four-fold higher mortality rate than the Danish population.

BACKGROUND & AIMS: We investigated mortality of patients with chronic pancreatitis (CP), compared with the Danish population and sought to determine whether clinical presentations of CP can be used in prognosis. We also investigated clinical factors associated with mortality and causes of death among these patients. METHODS: The Copenhagen Pancreatitis Study is a prospective study of patients admitted from 1977 to 1982 to the 5 main hospitals in Copenhagen with a diagnosis of acute pancreatitis or CP. In 2008, follow-up data were collected from these patients from the Danish Registries; this subcohort comprised 290 patients with probable (n = 41) or definite CP (n = 249). RESULTS: The mortality of patients with definite CP was 4-fold that of the Danish population and significantly higher than that of patients with probable CP (P = .003; 95% confidence interval [CI], 1.21-2.57); patients with probable CP had a 2- to 3-fold higher mortality rate than the population. In patients with definite CP, factors significantly associated with mortality included non-employment (P = .015; 95% CI, 0.53-0.93), and being underweight (P = .020; 95% CI, 0.52-0.95). Sex, alcohol use, smoking, single versus co-living, exocrine insufficiency, diabetes, pancreatic calcification, CP inheritance, painless CP, acute exacerbation of CP, or surgery for CP had no impact on survival. The most frequent causes of death were digestive diseases (19.5%), malignancies (19.5%), and cardiovascular diseases (11.3%). CONCLUSIONS: Danish patients with definite CP had a 4-fold higher mortality rate compared with the background population and a higher mortality rate than patients with probable CP. Being nonemployed or underweight had significant impact on survival.

Effect of High Versus Low Carbohydrate Intake in the Morning on Glycemic Variability and Glycemic Control Measured by Continuous Blood Glucose Monitoring in Women with Gestational Diabetes Mellitus-A Randomized Crossover Study.

Carbohydrate is the macronutrient that has the greatest impact on blood glucose response. Limited data are available on how carbohydrate distribution throughout the day affects blood glucose in women with gestational diabetes mellitus (GDM). We aimed to assess how a high-carbohydrate morning-intake (HCM) versus a low-carbohydrate-morning-intake (LCM), affect glycemic variability and glucose control. In this randomized crossover study continuous glucose monitoring (CGM) was performed in 12 women with diet treated GDM (75 g, 2-h OGTT ≥ 8.5 mmol/L), who went through 2 × 3 days of HCM and LCM. A within-subject-analysis showed a significantly higher mean amplitude of glucose excursions (MAGE) (0.7 mmol/L, p = 0.004) and coefficient of variation (CV) (5.1%, p = 0.01) when comparing HCM with LCM, whereas a significantly lower mean glucose (MG) (-0.3 mmol/L, p = 0.002) and fasting blood glucose (FBG) were found (-0.4 mmol/L, p = 0.01) on the HCM diet compared to the LCM diet. In addition, insulin resistance, expressed as Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), decreased significantly during HCM. Results indicate that a carbohydrate distribution of 50% in the morning favors lower blood glucose and improvement in insulin sensitivity in women with GDM, but in contrary gives a higher glycemic variability.

A Single Urine Sodium Measurement May Validly Estimate 24-hour Urine Sodium Excretion in Patients With an Ileostomy.

BACKGROUND: Sodium deficiency in patients with an ileostomy is associated with chronic dehydration and may be difficult to detect. We aimed to investigate if the sodium concentration in a single spot urine sample may be used as a proxy for 24-hour urine sodium excretion. METHODS: In a prospective observational study with 8 patients with an ileostomy and 8 volunteers with intact intestines, we investigated the correlations and agreements between spot urine sodium concentrations and 24-hour urine sodium excretions. Spot urine samples were drawn from every micturition during 24 hours, and relevant blood samples were drawn. All participants documented their food and fluid intakes. RESULTS: There was a high and statistically significant correlation between 24-hour natriuresis and urine sodium concentrations in both morning spot samples (n = 8, Spearman's rho [ρ] = 0.78, P = 0.03) and midday spot samples (n = 8, ρ = 0.82, P = 0.02) in the patients with an ileostomy. The agreement between methods was fair (bias = -1.5, limits of agreement = -32.3 to 29.4). There were no statistically significant associations for evening samples or for samples from volunteers with intact intestines independently of time of day. CONCLUSION: A single spot urine sodium sample obtained in the morning or midday may estimate 24-hour urine sodium excretion in patients with an ileostomy and thus help to identify sodium depletion.

Fish oil supplementation in cancer patients. Capsules or nutritional drink supplements? A controlled study of compliance.

BACKGROUND & AIMS: Fish-oil, rich in Omega-3 long chain polyunsaturated fatty acids (n-3 LC PUFAs), may in high doses inhibit the development or progression of cancer cachexia. However, poor compliance to oral nutritional supplements is a well-known problem. We aimed to investigate acceptability and compliance to a nutritional drink with fish-oil compared to an equivalent dose of fish-oil administered as capsules in patients receiving chemotherapy for GI tract cancers. Moreover, we aimed to investigate, if there was a difference between a nutritional drink or capsules with respect to nutritional status and side effects. Finally, we aimed to examine, if n-3 LC PUFAs affect leukocyte and platelet counts, and markers of dose-limiting toxicities of chemotherapy. METHODS: We consecutively included 41 patients with advanced cancer in the controlled study. Patients were allocated (not randomized) to ingest either 10 capsules/day for four weeks or 400 mL/day of a nutritional drink with same dose of n-3 LC PUFA dose. Compliance was assessed by daily self-registration and n-3 LC PUFAs in whole blood. Side effects were assessed by 10 cm visual analog scales. RESULTS: Compliance and daily consumption of n-3 LC PUFAs were 96.4% (94.1-99.3) and 4.8 (4.7-4.9) g/day in the capsule group and 80.8 (55.4-93.6) % and 4.0 (2.8-4.7) g/day in the group, respectively (p ≤ 0.02). We found no differences between the groups with respect to changes in whole blood n-3 LC PUFAs, weight, nutritional status, acceptability or side effects. However, in the capsule group the whole blood n-3 LC PUFAs correlated negatively with the increase in nausea (rs = -0.39, p = 0.05), but not in the nutritional drink group. Nausea, reduced appetite and loose stools were of greatest importance for the deviations from recommended doses. The number of capsules had a negative impact on acceptability and compliance, whereas this was mainly related to taste and texture in the nutritional drink group. No changes in median thrombocyte or leukocyte blood counts were observed. CONCLUSIONS: Fish oil in capsules appeared to result in better compliance compared to a nutritional drink with an equivalent dose of n-3 LC PUFAs. However, capsules and the drink did not differ with respect to the effect on nutritional status or side effects. TRIAL REGISTRATION CLINICALTRIALS. GOV IDENTIFIER: NCT03751384.