Changes In Lean Body Mass Research Articles

The Effects of Imeglimin on Muscle Strength in Patients with Type 2 Diabetes: A Prospective Cohort Study.

A bidirectional relationship has been observed between type 2 diabetes mellitus and sarcopenia, especially among older adults. While previous studies have reported that imeglimin improves mitochondrial function, they have not assessed its effects on muscle strength in patients with type 2 diabetes. Therefore, we aimed to investigate the effects of imeglimin on muscle strength in patients with type 2 diabetes. In this prospective cohort study, we recruited consenting patients with type 2 diabetes (20-75years). Changes in lean body mass (LBM), fat mass, quadriceps muscle strength, and grip strength from baseline (week 0) to week 24 were evaluated and compared between patients treated with imeglimin therapy (group I) and those who did not take imeglimin (controls, group C). We recruited 27 patients treated with imeglimin (group I) and 29 controls (group C), and 50 of them completed the study (group I: n = 23; group C: n = 27). The change in LBM, total body fat mass, or skeletal muscle index from baseline to week 24 did not differ significantly between the two groups. However, group I exhibited a significantly higher percent change in quadriceps knee extension strength from baseline to week 24 than group C (13 ± 19% and 2.1 ± 14%, p = 0.022). Conversely, the difference in percent change in grip strength was not significant. Multivariable analysis showed that imeglimin use was significantly associated with a percent change in quadriceps knee extension strength, independent of age, sex, body mass index, and skeletal mass index (β = 0.325, p = 0.0014). Imeglimin positively affected muscle strength in patients with type 2 diabetes without altering LBM. Therefore, imeglimin exerts a unique effect on skeletal muscles in humans. Further randomized controlled trials are needed to validate these findings. This research was registered in the University Hospital Medical Information Network (UMIN, UMIN000054715).

Changes in lean body mass with glucagon-like peptide-1-based therapies and mitigation strategies.

Weight loss induced by glucagon-like peptide-1 receptor agonists (GLP-1RAs) and dual glucagon-like peptide-1 receptor (GLP-1R)/glucose-dependent insulinotropic polypeptide receptor agonists is coming closer to the magnitudes achieved with surgery. However, with greater weight loss there is concern about potential side effects on muscle quantity (mass), health and function. There is heterogeneity in the reported effects of GLP-1-based therapies on lean mass changes in clinical trials: in some studies, reductions in lean mass range between 40% and 60% as a proportion of total weight lost, while other studies show lean mass reductions of approximately 15% or less of total weight lost. There are several potential reasons underlying this heterogeneity, including population, drug-specific/molecular, and comorbidity effects. Furthermore, changes in lean mass may not always reflect changes in muscle mass as the former measure includes not only muscle but also organs, bone, fluids, and water in fat tissue. Based on contemporary evidence with the addition of magnetic resonance imaging-based studies, skeletal muscle changes with GLP-1RA treatments appear to be adaptive: reductions in muscle volume seem to be commensurate with what is expected given ageing, disease status, and weight loss achieved, and the improvement in insulin sensitivity and muscle fat infiltration likely contributes to an adaptive process with improved muscle quality, lowering the probability for loss in strength and function. Nevertheless, factors such as older age and severity of disease may influence the selection of appropriate candidates for these therapies due to risk of sarcopenia. To further improve muscle health during weight loss, several pharmacological treatments to maintain or improve muscle mass designed in combination with GLP-1-based therapies are under development. Future research on GLP-1-based and other therapies designed for weight loss should focus on more accurate and meaningful assessments of muscle mass, composition, as well as function, mobility or strength, to better define their impact on muscle health for the substantial number of patients who will likely be taking these medications well into the future.

Changes in body composition in early breast cancer patients treated with aromatase inhibitors

PurposeThe aim of the study was to analyze the modification of total and regional body composition in early breast cancer patients treated with aromatase inhibitors (AIs).MethodsThis is a prospective, single-center, observational, longitudinal study. Four-hundred and twenty-eight patients treated with adjuvant aromatase inhibitors were enrolled at the Medical Oncology and Breast Unit of Spedali Civili Hospital in Brescia from September 2014 to June 2022. Several body composition parameters including total and regional fat and lean body mass were investigated with dual-energy X-ray absorptiometry (DXA) scan at baseline and after 18 months of treatment with aromatase inhibitors.ResultsA significant increase in fat body mass (mean + 7.2%, 95% confidence interval [CI]: 5.5;8.9%) and a reduction in lean body mass (mean −3.1%, 95% CI −3.9; −2.4) were documented in this population. The changes in fat and lean body mass varied considerably according to different body districts ranging between + 3.2% to + 10.9% and from−1.3% to −3.9%, respectively.ConclusionAromatase inhibitor adjuvant therapy in early breast cancer is associated with changes in body composition, with a wide variability among different body districts, leading to a risk of sarcopenic obesity. Supervised physical exercise that focuses on single body parts that may display detrimental variations may be beneficial for AIs treated patients.

The Effect of Palmitoylethanolamide (PEA) on Skeletal Muscle Hypertrophy, Strength, and Power in Response to Resistance Training in Healthy Active Adults: A Double-Blind Randomized Control Trial

BackgroundPalmitoylethanolamide (PEA) has analgesic/anti-inflammatory properties that may be a suitable alternative to over-the-counter (OTC) non-steroidal analgesics/anti-inflammatories. While OTC pain medications can impair strength training adaptations, the mechanism of action of PEA is distinct from these and it may not negatively affect skeletal muscle adaptations to strength training.MethodsThe primary aim of this study was to investigate the effects of daily PEA supplementation (350 mg Levagen + equivalent to 300 mg PEA) combined with 8-weeks of resistance training on lean body mass with secondary aims addressing strength, power, sleep, and wellbeing compared to placebo (PLA) in young, healthy, active adults. In a randomized, controlled, double-blinded trial, 52 untrained, recreationally active participants aged 18–35 y were allocated to either the PEA or PLA groups. Participants consumed either 2 × 175 mg Levagen + PEA or identically matched maltodextrin capsules during an 8-week period of whole-body resistance training. This trial assessed the pre- to post- changes in total and regional lean body mass, muscular strength (1-RM bench, isometric mid-thigh pull), muscular power [countermovement jump (CMJ), bench throw], pain associated with exercise training, sleep, and wellbeing compared with the PEA or PLA condition.Results48 Participants were included in the final intention to treat (ITT) analysis and we also conducted per protocol (PP) analysis (n = 42). There were no significant between-group differences for total or regional lean muscle mass post-intervention. There was a significantly higher jump height (CMJ) at week 10 in the PEA group compared to the PLA (Adjusted mean difference [95% CI] p-value; ITT: − 2.94 cm [− 5.15, − 0.74] p = 0.010; PP: − 2.93 cm [− 5.31, − 0.55] p = 0.017). The PLA group had higher 1-RM bench press post-intervention compared with the PEA group (ITT: 2.24 kg [0.12, 4.37] p = 0.039; PP: 2.73 kg [0.40, 5.06] p = 0.023). No significant treatment effects were noted for any of the other outcomes.ConclusionPEA supplementation, when combined with 8 weeks of strength training, did not impair lean mass gains and it resulted in significantly higher dynamic lower-body power when compared with the PLA condition.Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p).

Comparison of resistance training using barbell half squats and trap bar deadlifts on maximal strength, power performance, and lean mass in recreationally active females: an eight-week randomised trial

BackgroundThe aim of this study was to investigate the effect of high load resistance training using barbell half squats compared with trap bar deadlifts on maximal strength, power performance, and lean mass in recreationally active females.MethodsTwenty-two recreationally active female participants (age: 26.9 ± 7.7 yrs.; height: 166.0 ± 5.1 cm; weight: 68.6 ± 9.9 kg) were randomly assigned to either a barbell half squat group (SG: n = 10) or trap bar deadlift group (DG: n = 12). Training consisted of twice-weekly sessions for eight weeks. Both groups completed one-repetition maximum (1RM) testing for both barbell half squat and trap bar deadlift groups. Countermovement jump (CMJ) and sprint performance were also assessed. Total body (TBLM) and leg lean mass (LLM) were measured with dual-energy x-ray absorptiometry. Between-group differences were analysed using analysis of covariance.ResultsSG tended to improve 1RM half squat (21.0 ± 11.5 kg vs. 13.1 ± 7.5 kg) more than DG (mean difference (MD): 8.0 kg, 95% CI: -0.36 – 16.3 kg). A similar pattern in favour of DG (18.4 ± 11.2 vs. 11.7 ± 8.1 kg) compared to SG was observed (MD: 6.5 kg, 95% CI: -2.5 – 15.6 kg). No between-group differences for sprint, jump or lean body mass changes was observed. For groups combined, the following changes in CMJ (2.0 ± 2.4 cm), 5-m sprint (-0.020 ± 0.039 s), 15-m sprint (-0.055 ± 0.230 s), TBLM (0.84 ± 1.12 kg), and LLM (0.27 ± 0.59 kg) was observed.ConclusionsAn exercise intervention consisting of half squats or trap bar deadlift were associated with improved muscle strength, power, and lean mass. Our findings suggests that in recreationally active females, exercise selection is less of a concern provided that heavy loads are applied, and relevant muscle groups are targeted.

Lean Body Mass, Muscle Architecture and Powerlifting Performance during Preseason and in Competition.

Lean body mass (LBM) is correlated with powerlifting performance in athletes competing in different bodyweight classes. However, it remains unknown whether changes in LBM are correlated with performance changes in powerlifters preparing for a competition. The aim of this study was to investigate the changes in LBM and performance in powerlifters preparing for a competition. Eight male powerlifters (age 31.7 ± 9.8 years, height 1.77 ± 0.06 m, weight 99.2 ± 14.6 kg) and three female powerlifters (age 32.7 ± 16.3 years, height 1.54 ± 0.06 m, weight 66.6 ± 20.9 kg) participated in the study. The athletes followed individualized periodized training programs for 12 weeks, aiming to maximize their performance for the national championship. The maximum strength (1-RM) in the squat, bench press, and deadlift, body composition, handgrip strength, anaerobic power, quadriceps' cross-sectional area and vastus lateralis muscle architecture were measured before and after the training period. Significant increases were found after the training period in the squat (5.8 ± 7.0%, p < 0.05), bench press (4.9 ± 9.8%, p = 0.05) and deadlift (8.3 ± 16.7%, p < 0.05). Significant correlations were found between the 1-RM and LBM before and after the training period (r > 0.75, p < 0.05). The changes in the 1-RM after the training intervention correlated with the changes in the total LBM (p < 0.05). These results suggest that individual changes in LBM due to systematic resistance training for a competition may dictate increases in the 1-RM strength in powerlifters.

Skeletal muscle adaptations to high-intensity, low-volume concurrent resistance and interval training in recreationally active men and women.

This study compared the structural and cellular skeletal muscle factors underpinning adaptations in maximal strength, power, aerobic capacity, and lean body mass to a 12-week concurrent resistance and interval training program in men and women. Recreationally active women and men completed three training sessions per week consisting of high-intensity, low-volume resistance training followed by interval training performed using a variety upper and lower body exercises representative of military occupational tasks. Pre- and post-training vastus lateralis muscle biopsies were analyzed for changes in muscle fiber type, cross-sectional area, capillarization, and mitochondrial biogenesis marker content. Changes in maximal strength, aerobic capacity, and lean body mass (LBM) were also assessed. Training elicited hypertrophy of type I (12.9%; p = 0.016) and type IIa (12.7%; p = 0.007) muscle fibers in men only. In both sexes, training decreased type IIx fiber expression (1.9%; p = 0.046) and increased total PGC-1α (29.7%, p < 0.001) and citrate synthase (11.0%; p < 0.014) content, but had no effect on COX IV content or muscle capillarization. In both sexes, training increased maximal strength and LBM but not aerobic capacity. The concurrent training program was effective at increasing strength and LBM but not at improving aerobic capacity or skeletal muscle adaptations underpinning aerobic performance.

Nutritional status, body composition and diet quality in children with cancer.

During cancer treatment, nutritional status disorders such as malnutrition or obesity affect the tolerance of cancer treatment, quality of life, but also the pharmacokinetics of drugs. It is hypothesized that changes in fat and lean body mass can modify chemotherapy volume distribution, metabolism and clearance. In children with cancer, lean body mass decreases or remains low during treatment and fat mass increases. Body composition is influenced by the cancer itself, aggressive multimodal-therapies, changes in metabolism, unbalanced diet and reduced physical activity. Due to the side effects of treatment, including changes in the sense of taste and smell, nausea, vomiting, diarrhea, and stress, eating according to recommendation for macronutrients and micronutrients is difficult. Research indicates that throughout cancer treatment, the consumption of fruits, vegetables, and dairy products tends to be insufficient, whereas there is an elevated intake of sugar and unhealthy snacks. Children exhibit a preference for high-carbohydrate, salty, and strongly flavored products. This review revealed the importance of body composition and its changes during cancer treatment in children, as well as eating habits and diet quality.

Effects of Milk Fat Globule Membrane Supplementation Following Exercise Training on Physical Performance in Healthy Young Adults: A Randomized Double-Blind, Placebo-Controlled Pilot Trial.

The purpose of this study was to examine whether 4 wk of daily ingestion of milk fat globule membrane (MFGM) combined with exercise training improves physical performance-muscle strength, agility and muscle power-in healthy young adults. The study was designed as a randomized, double-blind, and placebo-controlled trial. Twenty healthy young adults received either an MFGM powder containing 1.6 g of fat and 160 mg of sphingomyelin or an isocaloric placebo powder daily throughout 4 wk of power or agility training. Physical performance tests and body composition measurements were conducted before and after the 4-wk intervention. Ingestion of MFGM did not affect isometric or isokinetic muscle strength, but it was associated with a greater increase in vertical jump peak power compared with placebo. There were no significant changes in body weight or lean body mass during the intervention period in either group, and no significant differences between groups. We conclude that daily MFGM supplementation combined with exercise training has the potential to improve physical performance in young adults; however, further studies with larger sample sizes should be conducted to obtain more evidence supporting achievement of improved physical performance through MFGM supplementation.

Effects of testosterone enanthate on aggression, risk-taking, competition, mood, and other cognitive domains during 28 days of severe energy deprivation

RationaleBehavioral effects of testosterone depend on dose, acute versus sustained formulation, duration of administration, personality, genetics, and endogenous levels of testosterone. There are also considerable differences between effects of endogenous and exogenous testosterone.ObjectivesThis study was the secondary behavioral arm of a registered clinical trial designed to determine if testosterone protects against loss of lean body mass and lower-body muscle function induced by a severe energy deficit typical of sustained military operations.MethodsBehavioral effects of repeated doses of testosterone on healthy young men whose testosterone was reduced by severe energy deficit were examined. This was a double-blind, placebo-controlled, between-group study. Effects of four weekly intramuscular injections of testosterone enanthate (200 mg/week, N = 24) or matching placebo (N = 26) were evaluated. Determination of sample size was based on changes in lean body mass. Tasks assessing aggression, risk-taking, competition, social cognition, vigilance, memory, executive function, and mood were repeatedly administered.ResultsDuring a period of artificially induced, low testosterone levels, consistent behavioral effects of administration of exogenous testosterone were not observed.ConclusionsExogeneous testosterone enanthate (200 mg/week) during severe energy restriction did not reliably alter the measures of cognition. Study limitations include the relatively small sample size compared to many studies of acute testosterone administration. The findings are specific to healthy males experiencing severe energy deficit and should not be generalized to effects of other doses, formulations, or acute administration of endogenous testosterone or studies conducted with larger samples using tests of cognitive function designed to detect specific effects of testosterone.

Hepcidin Reduction during Testosterone Therapy in Men with Type 2 Diabetes: A Randomized, Double-Blinded, Placebo-Controlled Study.

A randomized, placebo-controlled, double-blinded study at an academic tertiary-care medical center. Interventions were testosterone gel (TRT, n = 20) or placebo gel (n = 19) for 24 weeks. We included 39 men (50-70 years) with type 2 diabetes (T2D) on metformin monotherapy with bioavailable testosterone levels <7.3 nmol/L. Body composition was assessed with DXA- and MRI-scans; the main study outcomes were serum hepcidin-iron, FGF23, phosphate, klotho, and calprotectin. Hepcidin levels decreased during TRT (β = -9.5 ng/mL, p < 0.001), lean body mass (β = 1.9 kg, p = 0.001) increased, and total fat mass (β = -1.3 kg, p = 0.009) decreased compared to placebo. Delta hepcidin was not associated with changes in lean body mass or fat mass. Iron and the pathways of FGF23-phosphate-klotho and calprotectin were unchanged during TRT. During TRT, the reduction in hepcidin was not associated with circulating iron levels, lean body mass, or fat mass; these findings suggested a direct anti-inflammatory effect of TRT and no indirect effect mediated through these factors.

Predictors of efficacy of anamorelin in patients with non‑small cell lung cancer and cachexia: A retrospective study.

Anamorelin, a ghrelin receptor agonist, is approved in Japan for the treatment of cachexia in patients with lung and gastrointestinal cancer. However, there is limited research on the usefulness of anamorelin in clinical settings, therefore, the present study evaluated its efficacy using patient characteristics. A total of 40 patients with non-small cell lung cancer and cachexia who were prescribed anamorelin in the Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine (Aomori, Japan) between July 2021 and November 2022, were retrospectively assessed. Anamorelin was prescribed at a dose of 100 mg once daily to patients who had lost >5% of their body weight within 6 months. All patients were weighed before treatment and those who continued anamorelin treatment for 12 weeks were also weighed at 12 weeks. A logistic regression analysis was used to analyze the association between background characteristics and early discontinuation of treatment with anamorelin (within 4 weeks). The median age was 67 years (range, 36-88), and 65% of the patients were male. There were 24 patients (60.0%) with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score 1, 11 patients (27.5%) with an ECOG-PS score 2 and five patients (12.5%) with an ECOG-PS score 3. The early discontinuation group included 11 patients (27.5%). An ECOG-PS score ≥2 (odds ratio, 7.85; 95% confidence interval, 1.43-43.21; P=0.018) was associated with early discontinuation. A total of 18/40 patients (45.0%) were able to continue anamorelin treatment for 12 weeks, and the mean change in body weight was +2.31 kg, which was a significant change from the weight recorded at baseline (P=0.027). The mean changes in lean body mass and soft lean mass between baseline and 12 weeks were +1.97 kg (P=0.14) and +1.26 kg (P=0.15), respectively. The results from the present study indicate that anamorelin is unlikely to be useful for patients with a poor general condition (ECOG-PS score ≥2).

The combined effect of rowing exercise and the intake of functional foods containing inulin on muscle mass and bone mineral density in older Japanese women.

Aging decreases muscle mass and bone mineral density (BMD), especially in older women. It has been reported that rowing and inulin intake positively affect muscle and bone, respectively. We examined the synergistic effect of rowing and functional food intake, including inulin, on lean body mass, BMD, and physical function parameters in older Japanese women. Fifty women aged 65-79 years were divided into four groups with or without inulin intake and rowing. The interventions were carried out for 12 weeks in each group. We assessed lean body mass and BMD using dual-energy X-ray absorptiometry at baseline and after the intervention and examined the changes in the values in each group. Lean body mass in all groups decreased, and the change in lean body mass in the group with rowing and inulin intake was significantly smaller than that in the group without them (-0.05 ± 0.61; -0.83 ± 0.59 kg; P = 0.030). The BMD in the three intervention groups increased after the 12-week intervention. The change in BMD in each of the three intervention groups showed significant differences compared with the control group (Rowing + Inulin: P = 0.03; Rowing + No inulin: P = 0.01; No rowing + Inulin: P < 0.01). Rowing and the intake of functional foods, including inulin, synergistically prevented a decrease in lean body mass. These factors, individually and additively, might increase BMD in older Japanese women. Geriatr Gerontol Int 2023; 23: 779-787.

Heterogeneity in regional changes in body composition induced by androgen deprivation therapy in prostate cancer patients: potential impact on bone health-the BLADE study.

It is not clear whether changes in body composition induced by androgen deprivation therapy (ADT) in prostate cancer (PC) patients are uniform or vary in the different body districts and whether regional lean body mass (LBM) and fat body mass (FBM) could have an impact on bone health. To prospectively evaluate the regional changes in LBM and FBM in PC patients submitted to degarelix; to explore the relationship of regional body composition and bone mineral density (BMD) and bone turnover markers. 29 consecutive non metastatic PC patients enrolled from 2017 to 2019. FBM, LBM and bone mineral density (BMD) evaluated by dual-energy x-ray absorptiometry (DXA) at baseline and after 12-month of ADT. Alkaline phosphate (ALP) and C-terminal telopeptide of type I collagen (CTX) assessed at baseline, 6 and 12months. All patients underwent degarelix administration. T-test or sign test and Pearson or Spearman test for continuous variables were used when indicated. Median percent increase in FBM ranged from + 14.5% in trunk to + 25.4% in the left leg after degarelix. LBM changes varied from + 2% in the trunk to -4.9% in the right arm. LBM in both arms and legs and their variations after degarelix directly correlated with ALP and inversely correlated with CTX. Lean mass of limbs, trunk and legs significantly correlated with BMD of the hip, lean mass of the trunk significantly correlated with spine BMD. These are post-hoc analysis of a prospective study and this is the main limitation. an heterogeneous change in body composition among body district is observed after ADT and bone turnover is influenced by lean mass and its variation. A supervised physical activity is crucial to maintain general physical performance and preserving bone health.

#4969 AN ADEQUATE HYDRATION MANAGEMENT IMPROVES THE EFFICIENCY OF INTRADIALYTIC PHOSPHATE REMOVAL

Abstract Background and Aims The excess of phosphate (P) is one of the major risk factors for death in patients undergoing hemodialysis (HD). Improving P removal efficiency should ameliorate their prognosis. We previously reported, increased urea nitrogen (UN) removal efficiency results in increased the removal efficiency of P from extracellular fluid (ECF), but did not improve that from intracellular fluid (ICF) (NDT, Vol 35, Sup3, P1401, 2020). We also reported that P removal from ICF accounted for in average about 44% of total intradialytic P removal. For improving total P removal efficiency, removal efficiency of P from ICF should be increased. As P is one of the major osmotic agents in ICF, water outflow from ICF will accompany P outflow. We explored correlation between intracellular P removal and intracellular water (ICW) reduction. And we also sought for the strategy which efficiently derive water from ICF in HD patients in order to increase intracellular P removal. Method Eighty-six patients undergoing 4-hour HD were enrolled this study. ICW, extracellular water (ECW) volume and body fat mass (BFM) in each patient were measured with biochemical impedance analysis method before and after HD session. Total body water (TBW) was calculated by ICW + ECW. The amount of intradialytic P removal from ICF and from ECF in each patient was calculated as previously reported (NDT, Vol 35, Sup3, P1401, 2020). The correlation between the amount of intradialytic P removal from ICF and the amount of ICW reduction was investigated. All patients were divided into three groups according to the amount of ICW reduction as high reduction (HR) group, middle reduction (MR) group and low reduction (LR) group. The amount of P removal from ICF was compared between these groups. ICW volume change (ΔICW%) was calculated as (preICW – postICW)/preICW in each patient. Where preICW = ICW volume at the starting of HD, postICW = ICW volume at the end of HD. Circulating plasma volume change (ΔCPV%) was calculated as (postTP – preTP)/postTP in each patient. Where postTP = serum total protein concentration (TP) at the end of HD, preTP = TP at the end of HD. Lean body mass (LBM) was calculated as BW – BFM. Body weight (BW) change (ΔBW%), LBM change (ΔLBM%) and TBW volume change (ΔTBW%) were calculated in the same way as ΔICW%. To seek factors that effectively reduce ICW, the correlation with ΔICW% in ECW/TBW ratio, ΔCPV%, ΔCPV%/ΔBW% ratio, ΔCPV%/ΔLBM% ratio and ΔCPV%/ΔTBW% ratio was examined. Results The amount of intradialytic P removal from ICF positively correlated to the amount of ICW volume reduction (R = 0.279, y = 66.3x+285, p = 0.0076). It indicates an average of 66.3mg of P was removed from ICF per 1L of ICW reduction. In HR group, the amount of P removal from ICF was significantly larger than that in LR group (315.6±117.8mg vs 383.7±121.7mg, p = 0.019). ΔICW% negatively correlated to ECW/TBW ratio (R = 0.481, p = 0.000057). High ECW/TBW ratio indicates excess of ECW, which suggests having edema. ΔICW% positively correlated to ΔCPV% (R = 0.511, p = 0.0000051). Low ΔCPV% suggests insufficient of ultrafiltration. ΔICW% negatively correlated to ΔCPV%/ΔTBW% ratio (R = 0.421, p = 0.00011). High ΔCPV%/ΔTBW% ratio indicates insufficient plasma refilling for ultrafiltration rate, which suggests overrate of ultrafiltration. But ΔICW% did not correlate to ΔCPV%/ΔBW% ratio (R = 0.184, p = 0.10) nor ΔCPV%/ΔLBM% ratio (R = 0.176, p = 0.12). Conclusion The amount of intradialytic P removal from ICF correlated to the amount of ICW reduction. For efficient reduction of ICW, low ECW/TBW ratio, high ΔCPV% and low ΔCPV%/ΔTBW% ratio were required. It was suggested that efficient P removal was achieved when non-edematous patients get ultrafiltration of appropriate rate and dose.

Effect of multimodal intervention care on cachexia in patients with advanced cancer compared to conventional management (MIRACLE): An open-label, parallel, randomized, phase 2 trial.

e24135 Background: Cancer Cachexia (CC) is a multi-factorial process characterized by progressive weight loss, muscle mass and fat tissue wasting, and adversely affecting their quality of life and survival in patients with advanced stage of cancer. We investigated the efficacy and safety of a multi-modal intervention including anti-inflammation, omega-3-fatty acids, nutritional supplement with counselling, physical exercise, psychiatric intervention as well as Bojungikki-tang which mediates immune-modulation and reverse chronic inflammation and wasting condition as a complementary and alternative medicine compared to patients receiving best supportive care. Methods: Eligible criteria included patients with advanced stage of gastrointestinal (gastric, colorectal and pancreaticobiliary) as well as lung cancer undergoing active palliative chemotherapy. Patients are randomized into experimental arm (Multi-modal intervention care: MIC) versus control arm (Conventional Palliative Care, CPC). MIC are comprised of daily oral medications; ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day, and weekly physical exercise (60 minutes per visit), psychiatric assessment on every other week, and nutritional counselling total four times during the study period. CPC included basic nutritional counselling for two times provided by National Health Insurance Service, and megestrol acetate as needed (ie, anorexia≥grade 2). All interventions were provided during 12 weeks per subject. Co-primary outcomes are total lean body mass changes and handgrip strength change from the baseline. Secondary outcomes included change of fat mass and total body mass, lean body mass, and quality of life assessment (KCT0004967, NCT 04907864). Results: A total of 112 patients was planned to be assigned to the two arms (56 in each group), however, the study was terminated due to low accrual rate and the expiration of the study approval period of the national research fund, after enrolling up to 56 subjects (28 in each group). Demographic findings were even distributed between arms. The difference of median changes of total lean body mass in MIC group after 12 weeks of intervention, was numerically increased without statistical significance compared to CPC group (MIC vs CPC, 91 vs. -295 g, p= 0.3863). There was no difference of median changes of handgrip strength between MIC and CPC groups (MIC vs CPC, 0.4 vs. 0.9, p= 0.2319). Other secondary outcomes showed no differences, either. Conclusions: Multimodal intervention in this study did not show clinical meaningful improvement. We have to further investigate another method to improve cachexia. Clinical trial information: NCT04907864 .

(362) Testosterone Replacement Therapy for Management of Cachexia: A Review of Current Literature

Abstract Introduction Cachexia is a progressively debilitating loss of skeletal muscle often seen in late-stage chronic medical diseases, such as cancer, HIV/AIDS, chronic obstructive pulmonary disease (COPD), and liver cirrhosis. Cachexia contributes to mortality and morbidity with reduced quality-of-life (QoL) and disease treatment options, and can be associated with adult-onset hypogonadism (AOH), which is commonly treated with testosterone replacement therapy (TRT) in men. Objective This comprehensive review highlights the current literature on TRT for management of patients with chronic disease-associated cachexia, with an emphasis on clinical outcomes and side effects. Specifically, we identify and highlight relevant primary literature and reviews published since 2000 on TRT for management of patients with cancer, COPD, HIV/AIDS, and liver cirrhosis. Methods A comprehensive PubMed literature review was performed to identify articles published between 2000-2021 on TRT and cachexia-related chronic medical diseases (cancer, COPD, HIV/AIDS, and liver cirrhosis) to highlight the use of TRT for management of AOH in male patients with cachexia. The list of studies generated by the initial search was screened to identify eligible studies. Inclusion criteria included primary literature with clinical outcome measures related to changes in lean body mass, muscle mass, body composition, QoL, fatigue scores, and/or exercise scores, in addition to relevant meta-analyses. Results 12 studies were included in our review out of 653 initial search results (Table 1). In three studies of TRT in cancer patients, there were mixed results on the effects of TRT on QoL assessment. Across three studies of TRT in COPD patients, there was consistent improvement in exercise capacity and disease condition with TRT. Across four studies of TRT in HIV-infected men, TRT resulted in notable improvement in body weight, muscle mass, function, and QoL. Lastly, in two studies of TRT in patients with cirrhosis, testosterone therapy improved muscle strength and body composition across both cohorts. Conclusions Based on recent studies, there is robust data for the clinical benefits of TRT for the management of certain subgroups of cachexic patients, specifically those with COPD, HIV, and liver cirrhosis. Because of mixed results in cancer cachexia patients, further investigation of its long-term efficacy is warranted, in addition to hormonal therapy for female cachexic patients. Disclosure No

Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients

ObjectivesTo evaluate the effectiveness of an innovative supervised exercise programme to mitigate the loss of lean body mass, functional capacity and quality of life in people with head and neck cancer, as well as to identify the optimal moment to apply it, before or after radiotherapy treatment, compared with the prescription of a physical activity plan carried out autonomously.MethodsPatients with squamous cell carcinoma of the head and neck (n = 144), treated with radiotherapy, will be randomly assigned to one of 3 comparison groups: pre-radiotherapy supervised exercise, post-radiotherapy supervised exercise and autonomous exercise, stratifying by human papillomavirus infection and previous surgery.The exercise programme will be carried out in 36 sessions over 12 weeks, combining moderate and high intensity strength and aerobic exercises. The main outcome variable is the change in lean body mass at 6 months measured by bioimpedance, while secondary variables are functional capacity, symptoms, quality of life and adverse effects. Longitudinal generalised mixed models will be used for the analyses of the repeated measurements at 3, 6, and 12 months after baseline.ConclusionsThe pilot study supports the feasibility and safety of the project. However, as the programme progressed, attendance at the sessions decreased. Strategies will be necessary for increasing attendance, as well as involving the patient in their recovery and other incentives. Follow-up after treatment to assess acute/late toxicity will enable us to know the response to both the exercise programme and its adherence.Trial registrationNCT04658706 Date and version identifier: March 1, 2023. Version 1.1

Efficacy and tolerability of a specific blend of amino acids in patients with anorexia nervosa treated in a hospital setting: study protocol for a randomized controlled trial

BackgroundSpecific blends of essential amino acids (EAA) containing a high percentage of branched-chain amino acids preserves mitochondrial metabolism and higher physical resistance in elderly mice, increasing their survival and improving physical performance and cognitive functions in malnourished elderly patients. However, no study has been yet done on patients with anorexia nervosa (AN) who regain weight with specialized intensive treatment. The present study aims to evaluate the efficacy of supplementation with EAA on the change in lean body mass (LBM) and other physical and psychological outcomes in patients with AN who are undergoing specialist treatment for eating disorders.MethodsThis is a 13-week randomized, double-blind, placebo-controlled study. Patients will be randomized to either a mixture of a complex blend of EAA and intermediates of the tricarboxylic acid (TCA) cycle (citrate, malate, succinate) supplementation (or placebo) upon admission at the intensive residential and day-hospital treatment for eating disorders. Ninety-two participants with AN aged 16–50 years will be recruited from a specialized intensive treatment of eating disorders. Double-blind assessment will be conducted at baseline (T0) and the end of the 13 weeks of treatment (T1). The study’s primary aim is to evaluate the efficacy of supplementation with EAA and TCA intermediates on the change in lean body mass (LBM) with weight restoration in patients with AN who are undergoing specialist treatment for eating disorders. The secondary aims of the study are to assess the effect of dietary supplementation on physical fitness, weight restoration, modification of AN and general psychopathology, and psychosocial impairment.DiscussionThe study’s results will inform researchers and clinicians on whether supplementing a mixture of EAA and TCA cycle intermediates will improve the increase of LBM and other important physical and psychological outcomes in patients with AN who regain weight with specialized intensive treatment.Trial registrationNCT, NCT05290285. Registered on 22 March 2022.

A Novel Use for Pelvic MRI Scans to Estimate Lean Body Mass and Screen for Sarcopenia in Patients With Rectal Cancer.

Sarcopenia, the combination of low lean body mass and decreased muscle strength, is associated with significant morbidity and mortality among patients with colorectal cancer. Standard methods for assessing lean body mass and muscle strength, such as bioelectric impedance analysis and handgrip dynamometry, are rarely obtained clinically. Per National Cancer Center Network recommendations, pelvic MRI is routinely collected for staging and surveillance among patients with rectal cancer. However, there are no data assessing the relationship of pelvic MRI lean body mass measurements at the fifth lumbar vertebrae with bioelectric impedance analysis, handgrip strength, or abdominal CT in patients with rectal cancer. Therefore, we aimed to assess whether pelvic MRI lean body mass correlates with a standard for lean body mass measurement (bioelectric impedance analysis), muscle function (handgrip strength), and an imaging modality frequently used in the literature to identify sarcopenia (abdominal CT at the third lumbar vertebrae). Lean body mass measurements from routinely collected pelvic MRI at the fifth lumbar vertebrae accurately and reproducibly estimate lean body mass and modestly correlate with handgrip strength. Rectal cancer pelvic MRI may be repurposed for identifying sarcopenia without increasing inconvenience, ionizing radiation exposure, or expenditure to patients with rectal cancer. Patients with locally advanced rectal cancer with pretreatment bioelectric impedance analysis and handgrip strength measurements within 3 months of their staging pelvic MRI were eligible. Axial skeletal muscle areas were segmented using T1-weighted series pelvic MRI at the fifth lumbar vertebrae and abdominal CT at the third lumbar vertebrae using Slice-O-Matic (Tomovision, Montreal, Canada). Lean body mass (kilograms) was derived from skeletal muscle area with standard equations. Handgrip strength (kilograms) was the maximum of 3 dominant hand attempts in the standing anatomical position. The primary outcome was the agreement between lean body mass measured by pelvic MRI (at the fifth lumbar vertebrae) and bioelectric impedance analysis. Secondary outcomes included the concordance of pelvic MRI lean body mass (at the fifth lumbar vertebrae) with abdominal CT (at the third lumbar vertebrae) and handgrip strength. Additionally, the intra- and interobserver validity, internal consistency, and the mean difference (bias) between lean body mass measurements by pelvic MRI and bioelectric impedance analysis were evaluated. Sixteen patients were eligible. The average lean body mass was similar and consistent across 2 observers between bioelectric impedance analysis and pelvic MRI. There was a strong correlation between lean body mass measured on pelvic MRI, bioelectric impedance analysis, and abdominal CT. The reliability of 2 pelvic MRI lean body mass measurements (2 weeks apart by blinded observers) and the correlation of lean body mass between pelvic MRI and bioelectric impedance analysis was strong. Inter- and intraobserver correlation, reliability, and internal consistency were strong for the entire cohort. There was a moderate correlation between pelvic MRI lean body mass and handgrip strength. Lean body mass measured at the fifth lumbar vertebrae on pelvic MRI is reproducible and correlates strongly with measurements from bioelectric impedance analysis (standard) and abdominal CT at the third lumbar vertebrae and modestly with handgrip strength. These data suggest that MRI lean body mass measurements may be a method to screen patients with rectal cancer for sarcopenia. Future studies may evaluate changes in lean body mass on serial pelvic MRI studies among patients with rectal cancer.