- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347773
Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity
Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity: a Pilot/Feasibility Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ting-Yun Lin, MD
- Phone Number: 2350 8862-6628-9779
- Email: water_h2o_6@hotmail.com
Study Contact Backup
- Name: Szu-chun Hung, MD
- Phone Number: 2350 8862-6628-9779
- Email: szuchun.hung@gmail.com
Study Locations
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-
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New Taipei City, Taiwan, 231
- Recruiting
- Taipei Tzu Chi Hospital
-
Contact:
- Ting-Yun Lin, MD
- Phone Number: 2350 8862-6628-9779
- Email: water_h2o_6@hotmail.com
-
Contact:
- Szu-chun Hung, MD
- Phone Number: 2350 8862-6628-9779
- Email: szuchun.hung@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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No Intervention: Control
The subjects will be assigned to receive standard care alone.
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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
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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
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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
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Measured by bioimpedance device
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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
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Handgrip test
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Measured at baseline and end of study, 4 months apart
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Change in albumin in mg/dl
Time Frame: Measured at baseline and end of study, 4 months apart
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laboratory test
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Measured at baseline and end of study, 4 months apart
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Change in CRP in mg/L.
Time Frame: Measured at baseline and end of study, 4 months apart
|
laboratory test
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Measured at baseline and end of study, 4 months apart
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ting-Yun Lin, MD, Taipei Tzu Chi Hospital, Division of Nephrology
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-M05-079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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