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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
Sponsor:
Information provided by (Responsible Party):
Ting-Yun Lin, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Requiring Chronic Dialysis Sarcopenic Obesity Body Composition Dietary Supplement: ReGen 18% Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open label randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  1. Change in lean tissue mass in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]
    Measured by bioimpedance device


Secondary Outcome Measures :
  1. Change in dry weight in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]
    Measured by bioimpedance device

  2. 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

  3. Change in fat tissue mass in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]
    Measured by bioimpedance device

  4. Change in muscle strength in kg [ Time Frame: Measured at baseline and end of study, 4 months apart ]
    Handgrip test

  5. Change in albumin in mg/dl [ Time Frame: Measured at baseline and end of study, 4 months apart ]
    laboratory test

  6. Change in CRP in mg/L. [ Time Frame: Measured at baseline and end of study, 4 months apart ]
    laboratory test



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
Contact: Ting-Yun Lin, MD 8862-6628-9779 ext 2350 water_h2o_6@hotmail.com
Contact: Szu-Chun Hung, MD 8862-6628-9779 ext 2350 szuchun.hung@gmail.com

Locations
Taiwan
Taipei Tzu Chi Hospital Recruiting
New Taipei City, Taiwan, 231
Contact: Ting-Yun Lin, MD    8862-6628-9779 ext 2350    water_h2o_6@hotmail.com   
Contact: Szu-chun Hung, MD    8862-6628-9779 ext 2350    szuchun.hung@gmail.com   
Sponsors and Collaborators
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Investigators
Principal Investigator: Ting-Yun Lin, MD Taipei Tzu Chi Hospital, Division of Nephrology

Publications:
Responsible Party: Ting-Yun Lin, Ting-Yun Lin, MD, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
ClinicalTrials.gov Identifier: NCT03347773     History of Changes
Other Study ID Numbers: 06-M05-079
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ting-Yun Lin, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation:
Oral nutritional supplement
Sarcopenic obesity
Body composition

Additional relevant MeSH terms:
Obesity
Kidney Diseases
Renal Insufficiency, Chronic
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Urologic Diseases
Renal Insufficiency