Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Kidney Disease Requiring Chronic Dialysis, Sarcopenic Obesity, Body Composition

Intervention / Treatment
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* Dietary Supplement: ReGen 18%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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%<br>* 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.<br>|
| No Intervention: Control<br>The subjects will be assigned to receive standard care alone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sarcopenic obesity, Body composition, Oral nutritional supplement