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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Control | No Intervention | The subjects will be assigned to receive standard care alone. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReGen 18% | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lean tissue mass in kg | Measured by bioimpedance device | Measured at baseline and end of study, 4 months apart |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dry weight in kg | Measured by bioimpedance device | Measured at baseline and end of study, 4 months apart |
| Change in body mass index in kg/m^2 | Measured by bioimpedance device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting-Yun Lin, MD | Contact | 8862-6628-9779 | 2350 | water_h2o_6@hotmail.com |
| Szu-Chun Hung, MD | Contact | 8862-6628-9779 | 2350 | szuchun.hung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ting-Yun Lin, MD | Taipei Tzu Chi Hospital, Division of Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | Recruiting | New Taipei City | 231 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25392147 | Background | Sharma D, Hawkins M, Abramowitz MK. Association of sarcopenia with eGFR and misclassification of obesity in adults with CKD in the United States. Clin J Am Soc Nephrol. 2014 Dec 5;9(12):2079-88. doi: 10.2215/CJN.02140214. Epub 2014 Nov 12. | |
| 24179011 | Background | Gracia-Iguacel C, Qureshi AR, Avesani CM, Heimburger O, Huang X, Lindholm B, Barany P, Ortiz A, Stenvinkel P, Carrero JJ. Subclinical versus overt obesity in dialysis patients: more than meets the eye. Nephrol Dial Transplant. 2013 Nov;28 Suppl 4:iv175-81. doi: 10.1093/ndt/gft024. |
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Open label randomized controlled trial
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| Measured at baseline and end of study, 4 months apart |
| Change in fat tissue mass in kg | Measured by bioimpedance device | Measured at baseline and end of study, 4 months apart |
| Change in muscle strength in kg | Handgrip test | Measured at baseline and end of study, 4 months apart |
| Change in albumin in mg/dl | laboratory test | Measured at baseline and end of study, 4 months apart |
| Change in CRP in mg/L. | laboratory test | Measured at baseline and end of study, 4 months apart |
| 24763868 | Background | Martinson M, Ikizler TA, Morrell G, Wei G, Almeida N, Marcus RL, Filipowicz R, Greene TH, Beddhu S. Associations of body size and body composition with functional ability and quality of life in hemodialysis patients. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1082-90. doi: 10.2215/CJN.09200913. Epub 2014 Apr 24. |
| 17021267 | Background | Pupim LB, Majchrzak KM, Flakoll PJ, Ikizler TA. Intradialytic oral nutrition improves protein homeostasis in chronic hemodialysis patients with deranged nutritional status. J Am Soc Nephrol. 2006 Nov;17(11):3149-57. doi: 10.1681/ASN.2006040413. Epub 2006 Oct 4. |
| 21629229 | Background | Kalantar-Zadeh K, Cano NJ, Budde K, Chazot C, Kovesdy CP, Mak RH, Mehrotra R, Raj DS, Sehgal AR, Stenvinkel P, Ikizler TA. Diets and enteral supplements for improving outcomes in chronic kidney disease. Nat Rev Nephrol. 2011 May 31;7(7):369-84. doi: 10.1038/nrneph.2011.60. |