Clinical trial NCT03347773: Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity
Official title: Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity: a Pilot/Feasibility Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Sarcopenic Obesity
Body Composition
Keywords: Oral nutritional supplement
Sarcopenic obesity
Body composition
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized controlled trial
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Aged between 40 y/o and 90 y/o
* Regular hemodialysis treatment at least 3 months
* Hemodialysis treatment thrice a week, 3.5-4.5 hours/session
* Body composition: body mass index \< 28 kg/m2 and body fat percentage \>25% for males or \>35% for females
* The normalized protein catabolic rate (nPCR) \< 1.2 g/kg/day

Exclusion Criteria:

* Inadequate Kt/V \<1.2
* Active malignancy
* Liver cirrhosis
* Active infection, including tuberculosis and AIDS
* Kidney transplant less than 6 months before study enrollment
* Patients hospitalized for more than 5 days within 3 months preceding enrollment
* Patients received intradialytic parental nutrition within 2 months preceding enrollment
* Inability to perform hand grip test, including patients with NG feeding or under bed-ridden status
* Patients with a cardiac pacemaker or metallic implants
* Patients are amputees
* Pregnant woman
* History of poor adherence to dialysis or medication

Primary outcomes:
measure: Change in lean tissue mass in kg
timeFrame: Measured at baseline and end of study, 4 months apart
Secondary outcomes:
measure: Change in dry weight in kg
timeFrame: Measured at baseline and end of study, 4 months apart
measure: Change in body mass index in kg/m^2
timeFrame: Measured at baseline and end of study, 4 months apart
measure: Change in fat tissue mass in kg
timeFrame: Measured at baseline and end of study, 4 months apart
measure: Change in muscle strength in kg
timeFrame: Measured at baseline and end of study, 4 months apart
measure: Change in albumin in mg/dl
timeFrame: Measured at baseline and end of study, 4 months apart
measure: Change in CRP in mg/L.
timeFrame: Measured at baseline and end of study, 4 months apart
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Tzu Chi Hospital
Study officials:
affiliation: Taipei Tzu Chi Hospital, Division of Nephrology
name: Ting-Yun Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.