Clinical Trials Logo

Clinical Trial Summary

Chronic kidney disease patients with sarcopenic obesity are noted to have impairment in physical performance and reducing their quality of life, and the investigators also founded these patients are at higher risk of mortality. Thus, the investigators hypothesize that oral nutrition intervention could increase lean tissue mass in these patients and improve the clinical outcomes.


Clinical Trial Description

In chronic kidney disease (CKD) patients, disease- and age- related changes in body composition, as well as the increased prevalence of obesity, determine a combination of excess weight and reduced muscle mass or strength, recently defined as sarcopenic obesity. The prevalence of sarcopenic obesity increase with lower eGFR, and previous studies showed that up to 18.3% stage 4 CKD patients and 56% prevalent hemodialysis patient to be with sarcopenic obesity. Sarcopenic obesity was negatively correlated with physical performance and quality of life. In the investigator's previous study, nondialysis-dependent CKD patients with normal body mass index (BMI) but excess body fat had the highest risk of death compared to those with BMI above the cutoff for obesity and excess body fat during a follow up of 5 years. These patients with excess body fat but lower lean tissue mass was what so called "sarcopenic obesity" group.

Hemodialysis therapy per se has been shown to be a catabolic process. Pupim et al. showed that in eight malnourished patients undergoing hemodialysis, highly positive whole-body net protein balance during hemodialysis and improvement of skeletal muscle protein homeostasis was achieved with an intradialytic oral nutritional supplement (ONS) compared to the control, and ONS during hemodialysis resulted in persistent anabolic benefits for muscle protein metabolism in the posthemodialysis phase. In the past, randomized trials of nutritional supplement intervention in dialysis patients were focused on populations with protein energy wasting, and most studies used change in serum albumin concentration as the surrogate marker. Studies focused on dialysis patients with sarcopenic obesity are sparse. Therefore, the investigators hypothesize that ONS could improve the nutritional status among dialysis patients with sarcopenic obesity, especially increase in lean tissue, and improve clinical outcomes. This pilot/feasibility study is aimed to conduct a randomised controlled pilot trial of the feasibility of undertaking a study to assess the effect of ONS on the nutritional status of haemodialysis patients with sarcopenic obesity and will lead to a more robust definitive trial in the future. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03347773
Study type Interventional
Source Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Contact Ting-Yun Lin, MD
Phone 8862-6628-9779
Email water_h2o_6@hotmail.com
Status Recruiting
Phase N/A
Start date November 1, 2017
Completion date April 2018

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05512559 - Body Composition Analysis and Time to Emergence From Remimazolam
Enrolling by invitation NCT05515835 - Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
Completed NCT04136821 - The Long-term Effects of Oceanix™ on Resistance Training Adaptations N/A
Completed NCT03432130 - Injury Occurrence in Hip-hop Dance N/A
Completed NCT04504799 - Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse
Withdrawn NCT04021446 - A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer N/A
Completed NCT02211612 - Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation N/A
Completed NCT03412578 - Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants N/A
Completed NCT02000492 - Frequent Ballgames Training for 9-11 Year Old Schoolchildren N/A
Completed NCT01209936 - Hydration Factor Study for the Stayhealthy BC3 N/A
Recruiting NCT06061315 - Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men N/A
Completed NCT05730660 - Quercetin Phytosome® Chronic Fatigue Syndrome N/A
Recruiting NCT04969588 - Kinect Equations for Body Indices and Body Composition
Completed NCT04828655 - Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure N/A
Completed NCT04404413 - High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women N/A
Completed NCT05052164 - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women N/A
Completed NCT03352583 - Effects of Casein Timing on Body Composition and Performance N/A
Enrolling by invitation NCT03587233 - Are Women With Higher Professional Status More Sedentary Compared to Men? N/A
Recruiting NCT05556239 - STAY-STRONG Study of Exercise Training During Chemotherapy N/A
Active, not recruiting NCT04306523 - Early Genetic and Environmental Influences on Eating - The Baylor Infant Twins Study