Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity
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|ClinicalTrials.gov Identifier: NCT03347773|
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Requiring Chronic Dialysis Sarcopenic Obesity Body Composition||Dietary Supplement: ReGen 18%||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Open label randomized controlled trial|
|Masking:||None (Open Label)|
|Official Title:||Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity: a Pilot/Feasibility Randomized Controlled Trial|
|Actual Study Start Date :||November 1, 2017|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
The subjects will be assigned to receive nutritional supplement consisting of one can of ReGen 18% (19.1 g protein, 425 Kcal) daily and standard care.
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.
No Intervention: Control
The subjects will be assigned to receive standard care alone.
- Change in lean tissue mass in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]Measured by bioimpedance device
- Change in dry weight in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]Measured by bioimpedance device
- Change in body mass index in kg/m^2 [ Time Frame: Measured at baseline and end of study, 4 months apart ]Measured by bioimpedance device
- Change in fat tissue mass in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]Measured by bioimpedance device
- Change in muscle strength in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]Handgrip test
- Change in albumin in mg/dl [ Time Frame: Measured at baseline and end of study, 4 months apart ]laboratory test
- Change in CRP in mg/L. [ Time Frame: Measured at baseline and end of study, 4 months apart ]laboratory test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03347773
|Contact: Ting-Yun Lin, MD||8862-6628-9779 ext firstname.lastname@example.org|
|Contact: Szu-Chun Hung, MD||8862-6628-9779 ext email@example.com|
|Taipei Tzu Chi Hospital||Recruiting|
|New Taipei City, Taiwan, 231|
|Contact: Ting-Yun Lin, MD 8862-6628-9779 ext 2350 firstname.lastname@example.org|
|Contact: Szu-chun Hung, MD 8862-6628-9779 ext 2350 email@example.com|
|Principal Investigator:||Ting-Yun Lin, MD||Taipei Tzu Chi Hospital, Division of Nephrology|