NCT03347773

Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity

Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity: a Pilot/Feasibility Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Kidney Disease Requiring Chronic Dialysis
• Sarcopenic Obesity
• Body Composition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ReGen 18%	ReGen 18% is a kind of oral nutritional supplement, designed for patients under regular hemodialysis. One can of ReGen 18% contains 237ml, 425 Kcal, 19.1g protein, 22.7g lipid and 37.9g carbohydrate.

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2017-11-20
• Last updated: 2017-11-20

Locations

1 site across 1 country: Taiwan