scholarly journals Muscle Status Response to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting: A Multi-Center Randomized, Open Label-Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Sharmela Sahathevan ◽  
Tilakavati Karupaiah ◽  
Ban-Hock Khor ◽  
Birinder Kaur Sadu Singh ◽  
Zulfitri Azuan Mat Daud ◽  
...  

Background: Muscle wasting, observed in patients with end-stage kidney disease and protein energy wasting (PEW), is associated with increased mortality for those on hemodialysis (HD). Oral nutritional supplementation (ONS) and nutrition counseling (NC) are treatment options for PEW but research targeting muscle status, as an outcome metric, is limited.Aim: We compared the effects of combined treatment (ONS + NC) vs. NC alone on muscle status and nutritional parameters in HD patients with PEW.Methods: This multi-center randomized, open label-controlled trial, registered under ClinicalTrials.gov (Identifier no. NCT04789031), recruited 56 HD patients identified with PEW using the International Society of Renal Nutrition and Metabolism criteria. Patients were randomly allocated to intervention (ONS + NC, n = 29) and control (NC, n = 27) groups. The ONS + NC received commercial renal-specific ONS providing 475 kcal and 21.7 g of protein daily for 6 months. Both groups also received standard NC during the study period. Differences in quadriceps muscle status assessed using ultrasound (US) imaging, arm muscle area and circumference, bio-impedance spectroscopy (BIS), and handgrip strength (HGS) methods were analyzed using the generalized linear model for repeated measures.Results: Muscle indices as per US metrics indicated significance (p < 0.001) for group × time interaction only in the ONS + NC group, with increases by 8.3 and 7.7% for quadriceps muscle thickness and 4.5% for cross-sectional area (all p < 0.05). This effect was not observed for arm muscle area and circumference, BIS metrics and HGS in both the groups. ONS + NC compared to NC demonstrated increased dry weight (p = 0.039), mid-thigh girth (p = 0.004), serum prealbumin (p = 0.005), normalized protein catabolic rate (p = 0.025), and dietary intakes (p < 0.001), along with lower malnutrition–inflammation score (MIS) (p = 0.041). At the end of the study, lesser patients in the ONS + NC group were diagnosed with PEW (24.1%, p = 0.008) as they had achieved dietary adequacy with ONS provision.Conclusion: Combination of ONS with NC was effective in treating PEW and contributed to a gain in the muscle status as assessed by the US, suggesting that the treatment for PEW requires nutritional optimization via ONS.

2021 ◽  
Author(s):  
ZHANG jing ◽  
TIAN jie ◽  
WANG hongling ◽  
HE zhengzhong

Abstract Background: Protein-energy wasting (PEW) is a common complication of maintenance hemodialysis (MHD) patients. This study aimed to explore the PEW evaluation method in MHD patients. Methods: Clinical data, physical parameters, laboratory values, and a questionnaire survey of MHD patients were collected from PEW and non-PEW patients in our hospital from September to December 2019. Analysis of variance was used to assess the difference between the two groups. ROC analysis was used to compare the diagnostic efficacy of physical measurement and nutrition scores and find the appropriate evaluation criteria for clinical application. Results: 1. There were statistically significant differences in many physical parameters between the two groups (p<0.05). 2. ROC curve analysis showed that the diagnostic efficiency of a single physical measurement or nutritional score was not high, and multiple indexes should be combined. 3. The simplified Pew risk score formula was 27.4 + abdominal circumference + 0.4 * main handgrip strength - 3.2 * body mass index -1.9 * upper arm circumference, which had a sensitivity of 67.7% and specificity of 94.4% at AUC of 0.864 and cutoff of 0.043346. Conclusion: A combination of abdominal circumference, main handgrip strength, BMI, and upper arm circumference could comprehensively evaluate PEW to improve the diagnostic efficiency.


2020 ◽  
Vol 319 (5) ◽  
pp. F885-F894
Author(s):  
Jorge L. Gamboa ◽  
Serpil Muge Deger ◽  
Bradley W. Perkins ◽  
Cindy Mambungu ◽  
Feng Sha ◽  
...  

Patients with end-stage kidney disease on maintenance hemodialysis commonly develop protein-energy wasting, a syndrome characterized by nutritional and metabolic abnormalities. Nutritional supplementation and exercise are recommended to prevent protein-energy wasting. In a 6-mo prospective randomized, open-label, clinical trial, we reported that the combination of resistance exercise and nutritional supplementation does not have an additive effect on lean body mass measured by dual-energy X-ray absorptiometry. To provide more mechanistic data, we performed a secondary analysis where we hypothesized that the combination of nutritional supplementation and resistance exercise would have additive effects on muscle protein accretion by stable isotope protein kinetic experiments, muscle mass by MRI, and mitochondrial content markers in muscle. We found that 6 mo of nutritional supplementation during hemodialysis increased muscle protein net balance [baseline: 2.5 (−17.8, 13.0) µg·100 mL−1·min−1 vs. 6 mo: 43.7 (13.0, 98.5) µg·100 mL−1·min−1, median (interquartile range), P = 0.04] and mid-thigh fat area [baseline: 162.3 (104.7, 226.6) cm2 vs. 6 mo: 181.9 (126.3, 279.2) cm2, median (interquartile range), P = 0.04]. Three months of nutritional supplementation also increased markers of mitochondrial content in muscle. Although the study is underpowered to detected differences, the combination of nutritional supplementation and exercise failed to show further benefit in protein accretion or muscle cross-sectional area. We conclude that long-term nutritional supplementation increases the skeletal muscle anabolic effect, the fat cross-sectional area of the thigh, and markers of mitochondrial content in skeletal muscle.


Author(s):  
Mariana Ayala ◽  
Margarita Marchant ◽  
Cristina Hertz ◽  
Gloria Castillo

Abstract Purpose The study assessed the impact of intradialytic oral nutritional supplementation on the quality of life in patients receiving hemodialysis and diagnosed with protein energy wasting. Methods A pre-test post-test quasi-experimental study was conducted before and after 3 months of intradialytic oral nutritional supplementation on 109 older hemodialysis patients. We measured before and after 3 months of intradialytic oral nutritional supplementation, the quality of life score, the burden of kidney disease, three quality of life scales and the mental and physical health status using KDQoL-SF™ 1.3, body composition and biochemical parameters of nutritional condition. Results The mean age of the patients was 69.4 ± 3.4 years, 59% were male, and the time on dialysis was 63.5 ± 52.6 months. Comparing the baseline with month 3 of intradialytic oral nutritional supplementation, we observed to better quality of life. In contrast to malnutrition, score, specifically increased significantly score of symptoms/problems list related to hemodialysis, sexual function, social and cognitive function, sleep, pain, energy/fatigue and general state of health. Significant changes were also found in nutritional status, energy intake and body composition indicators. After 3 months of intradialytic oral nutritional supplementation, we observed a nutritional status recovery in one or more indicators in 92% of the patients. Conclusion Our findings indicate that 3 months of intradialysis oral nutritional supplementation improves the components of physical and mental quality of life and nutritional status in older patients receiving hemodialysis diagnosed with loss of protein energy. These results are relevant to improve the experience of patients with protein energy loss receiving hemodialysis.


Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Giovani Missio ◽  
Doris Hupfeld Moreno ◽  
Frederico Navas Demetrio ◽  
Marcio Gerhardt Soeiro-de-Souza ◽  
Fernando dos Santos Fernandes ◽  
...  

Abstract Background Treatment of bipolar disorder (BD) usually requires drug combinations. Combinations of lithium plus valproic acid (Li/VPA) and lithium plus carbamazepine (Li/CBZ) are used in clinical practice but were not previously compared in a head-to-head trial. Objective The objective of this trial was to compare the efficacy and tolerability of Li/VPA versus Li/CBZ in treating type 1 BD in any phase of illness in young individuals. Methods LICAVAL was a randomized, unicenter, open-label, parallel-group trial that was conducted from January 2009 to December 2012 in a tertiary hospital in São Paulo, Brazil. Participants were between 18 and 35 years old and were followed up for 2 years. Our primary outcome was the number of participants achieving/maintaining response and remission during the acute and maintenance phases of BD treatment, respectively. Other outcomes assessed were symptom severity and adverse events throughout the study. In the analysis of the primary outcome, we compared groups by using a two-way repeated measures analysis of variance and estimated effect sizes by using Cohen’s d. Results Of our 64 participants, 36 were allocated to Li/VPA and 28 to Li/CBZ. Our sample was composed predominantly of females (66.6%) and the average age was 27.8 years. A total of 27 (45.0%) participants had depression, 17 (28.3%) had mania/hypomania, and 16 (26.7%) had a mixed state. We found no between-group differences in CGI-BP (Clinical Global Impression Scale modified for use in bipolar disorder) scores (P = 0.326) or in any other outcome. Side effects differed significantly between groups only in the first week of treatment (P = 0.021), and there were more side effects in the Li/VPA group. Also, the Li/VPA group gained weight (+2.1 kg) whereas the Li/CBZ group presented slight weight loss (−0.2 kg). Conclusion Our study suggests that Li/VPA and Li/CBZ have similar efficacy and tolerability in BD but that Li/CBZ might have metabolic advantages in the long term. Trial registration ClinicalTrials.gov identifier: NCT00976794. Registered on September 9, 2009.


2020 ◽  
Vol 17 ◽  
pp. 147997312090495 ◽  
Author(s):  
Abdulelah M Aldhahir ◽  
Ahmed M Al Rajeh ◽  
Yousef S Aldabayan ◽  
Salifu Drammeh ◽  
Vanitha Subbu ◽  
...  

Uptake of nutritional supplementation during pulmonary rehabilitation (PR) for people with chronic obstructive pulmonary disease (COPD) has been limited by an absence of rigorous evidence-based studies supporting use. The objective was to report and summarise the current evidence supporting the use of nutritional supplementation to improve outcomes during PR in stable COPD patients. A systematic search was conducted up to 7 August 2019 (registration number CRD42018089142). The preferred reporting items for systematic reviews and meta-analyses guidelines were used. Six databases were included: Medical Literature Analysis and Retrieval System Online or MEDLARS Online, Allied and Complementary Medicine Database, the Cochrane Database of Systematic Reviews, Excerpta Medica dataBASE, Cumulative Index of Nursing and Allied Health Literature and Web of Science. This systematic search generated 580 initial matches, of which 22 studies (917 COPD participants) met the pre-specified criteria and were included. Sixteen of 19 studies that used nutritional supplements in addition to PR did not show additional benefit compared to PR alone when measuring exercise capacity. Nutritional supplements significantly increased body weight in 7 of 11 studies. Body mass index increased significantly in two of six studies. Handgrip strength did not improve, while quadriceps muscle strength significantly improved in 3 of 11 studies. Four of eight studies showed a significant improvement in inspiratory muscle function. Only 2 of 14 studies demonstrated a significant improvement in quality of life with supplementation in addition to PR. There remains insufficient evidence on the effect of nutritional supplementation on improving outcomes during PR in patients with COPD due to heterogeneity in supplements, outcome measures and PR programmes. Therefore, controversy remains and further research is needed.


2011 ◽  
Vol 107 (2) ◽  
pp. 263-271 ◽  
Author(s):  
George PrayGod ◽  
Nyagosya Range ◽  
Daniel Faurholt-Jepsen ◽  
Kidola Jeremiah ◽  
Maria Faurholt-Jepsen ◽  
...  

Undernutrition is common among smear-positive pulmonary tuberculosis (PTB+) patients. Micronutrient supplementation may improve treatment outcomes, but it is unclear whether additional energy–protein would be beneficial. The present study aimed to assess the effect of energy–protein supplementation on weight, body composition and handgrip strength against a background of high micronutrient intake during tuberculosis (TB) treatment. A total of 377 PTB+ patients co-infected with HIV were randomly allocated one or six biscuits daily for 60 d during TB treatment. Weight, arm fat area, arm muscle area and handgrip strength were assessed at baseline and 2 and 5 months. There were no effects on any outcome at 2 months, but energy–protein supplementation was associated with a 1·3 (95 % CI − 0·1, 2·8) kg marginally significant gain in handgrip strength at 5 months. However, after 2 months, energy–protein supplementation led to a weight gain of 1·9 (95 % CI 0·1, 3·7) kg among patients with cluster of differentiation 4 (CD4) counts ≥ 350 cells/μl, but not among patients with low CD4 counts ( − 0·2 kg; 95 % CI − 1·3, 0·8, Pinteraction = 0·03). Similarly, at 5 months, energy–protein supplementation led to a 2·3 (95 % CI 0·6, 4·1) kg higher handgrip strength gain among patients with CD4 counts < 350 cells/μl, but not in those with high CD4 counts (Pinteraction = 0·04). In conclusion, energy–protein supplementation to PTB+ HIV-co-infected patients had no overall effects on weight and body composition, but was associated with marginally significant gain in handgrip strength. More research is needed to develop an effective supplement, before it is recommended to TB programmes.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9133-9133 ◽  
Author(s):  
J. Garcia ◽  
R. V. Boccia ◽  
C. Graham ◽  
K. Kumor ◽  
W. Polvino

9133 Background: Cancer cachexia is closely correlated with poor outcome and poor survival. RC is an oral ghrelin mimetic with orexigenic and anabolic activity. Methods: A phase II trial enrolled 81 patients with cancer, performance scores of 0–2, and weight loss of 5% or more within 6 months prior to enrollment at 17 sites in the US. Patients were randomized to treatment with two placebo (PL) or two 25 mg RC capsules taken once daily for 12 weeks. Outcome measures included lean body mass (LBM), total body mass (TBM) by DEXA (central reading), scale weight, handgrip strength (HS) and QOL measures. Biochemical markers included IGF-1 and IGFBP-3. In the per protocol analysis (32 RC, 28 PL) more than 20 cancer types were represented; the most common were lung (n=13) and colorectal cancer (n=15). The two treatment groups were balanced at baseline except for (RC vs PL, respectively): gender (66 % male vs 57 %), TBM (60.9 kg vs 65.3 kg), and HS (53.8 kg vs 56.6 kg). The analyses (repeated measures ANOVA without imputation) included all available data from the patients. Results: TBM and LBM (primary endpoint at 8 wks) were significantly increased vs. PL at wks 4 and 8 and at wks 4, respectively. The magnitude of the increase vs. baseline was stable from wk 4 through wk 12 during RC treatment for both TBM and LBM. HS was increased at significantly at wk 8. IGF-1 and IGFBP-3 significantly increased at wks 4, 8, and 12. No significant differences were found on the QOL or scale weight measures. RC was well tolerated. Patients having any AEs were 96% vs 87% and SAEs were 32% and 26% for RC and PL, respectively. The percent of patients and types of AEs were similar; possible exceptions included cardiac events and infections (11% vs 3% and 30% vs 42%, RC vs PL, respectively). Conclusions: In this randomized, double-blind, placebo-controlled trial, RC treatment led to improvements in LBM, TBM and HS. RC-1291 is a promising potential therapeutic agent for the treatment of cancer cachexia. No significant financial relationships to disclose.


Nutrients ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 3597
Author(s):  
Sharmela Sahathevan ◽  
Ban-Hock Khor ◽  
Birinder Kaur Sadu Singh ◽  
Alice Sabatino ◽  
Enrico Fiaccadori ◽  
...  

This study aimed to assess muscle wasting and risk of protein energy wasting (PEW) in hemodialysis (HD) patients using an ultrasound (US) imaging method. PEW was identified using the ISRNM criteria in 351 HD patients. Quadriceps muscle thickness of rectus femoris (RF) and vastus intermedius (VI) muscles and cross-sectional area (CSA) of the RF muscle (RFCSA) were measured using US and compared with other physical measures. Associations of US indices with PEW were determined by logistic regression. Irrespective of gender, PEW vs. non-PEW patients had smaller RF, VI muscles, and RFCSA (all p < 0.001). US muscle sites (all p < 0.001) discriminated PEW from non-PEW patients, but the RFCSA compared to bio-impedance spectroscopy had a greater area under the curve (AUC, 0.686 vs. 0.581), sensitivity (72.8% vs. 65.8%), and specificity (55.6% vs. 53.9%). AUC of the RFCSA was greatest for PEW risk in men (0.74, 95% CI: 0.66–0.82) and women (0.80, 95% CI: 0.70–0.90) (both p < 0.001). Gender-specific RFCSA values (men < 6.00 cm2; women < 4.47 cm2) indicated HD patients with smaller RFCSA were 8 times more likely to have PEW (AOR = 8.63, 95% CI: 4.80–15.50, p < 0.001). The US approach enabled discrimination of muscle wasting in HD patients with PEW. The RFCSA was identified as the best US site with gender-specific RFCSA values to associate with PEW risk, suggesting potential diagnostic criteria for muscle wasting.


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