Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity

November 15, 2017 updated by: Ting-Yun Lin, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lean tissue mass in kg
Time Frame: Measured at baseline and end of study, 4 months apart
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
Time Frame: Measured at baseline and end of study, 4 months apart
Measured by bioimpedance device
Measured at baseline and end of study, 4 months apart
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
Measured at baseline and end of study, 4 months apart
Change in fat tissue mass in kg
Time Frame: Measured at baseline and end of study, 4 months apart
Measured by bioimpedance device
Measured at baseline and end of study, 4 months apart
Change in muscle strength in kg
Time Frame: Measured at baseline and end of study, 4 months apart
Handgrip test
Measured at baseline and end of study, 4 months apart
Change in albumin in mg/dl
Time Frame: Measured at baseline and end of study, 4 months apart
laboratory test
Measured at baseline and end of study, 4 months apart
Change in CRP in mg/L.
Time Frame: Measured at baseline and end of study, 4 months apart
laboratory test
Measured at baseline and end of study, 4 months apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ting-Yun Lin, MD, Taipei Tzu Chi Hospital, Division of Nephrology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

November 12, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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