Oral Nutritional Supplement Intervention Among Hemodialysis Patients With Sarcopenic Obesity

NCT03347773 | Unknown

• 1 other identifier: 06-M05-079
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease Requiring Chronic Dialysis; Sarcopenic Obesity; Body Composition

Keywords

Oral nutritional supplement; Sarcopenic obesity; Body composition

Outcome Measures

Primary Outcomes (1)

• Change in lean tissue mass in kg

  Measured by bioimpedance device

  Measured at baseline and end of study, 4 months apart

Secondary Outcomes (6)

• Change in dry weight in kg

  Measured at baseline and end of study, 4 months apart

• Change in body mass index in kg/m^2

  Measured at baseline and end of study, 4 months apart

• Change in fat tissue mass in kg

  Measured at baseline and end of study, 4 months apart

• Change in muscle strength in kg

  Measured at baseline and end of study, 4 months apart

• Change in albumin in mg/dl

  Measured at baseline and end of study, 4 months apart

Study Arms (2)

Intervention

EXPERIMENTAL

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%

Control

NO INTERVENTION

The subjects will be assigned to receive standard care alone.

Interventions

ReGen 18% DIETARY_SUPPLEMENT

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation: lead

Study Sites (1)

Taipei Tzu Chi Hospital

New Taipei City, 231, Taiwan

RECRUITING

Related Publications (5)

• 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.

  PMID: 25392147 BACKGROUND

• 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.

  PMID: 24179011 BACKGROUND

• 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.

  PMID: 24763868 BACKGROUND

• 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.

  PMID: 17021267 BACKGROUND

• 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.

  PMID: 21629229 BACKGROUND

Study Officials

• Ting-Yun Lin, MD

  Taipei Tzu Chi Hospital, Division of Nephrology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Yun Lin, MD

CONTACT

8862-6628-9779; water_h2o_6@hotmail.com

Szu-Chun Hung, MD

CONTACT

8862-6628-9779; szuchun.hung@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ting-Yun Lin, MD

Model Details: Open label randomized controlled trial

Study Record Dates

• First Submitted: November 12, 2017
• First Posted: November 20, 2017
• Study Start: November 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 20, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)