Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study

Results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial

Manoch Rattanasompattikul, Miklos Z. Molnar, Martin L. Lee, Ramanath Dukkipati, Rachelle Bross, Jennie Jing, Youngmee Kim, Anne C. Voss, Debbie Benner, Usama Feroze, Iain C. MacDougall, John A. Tayek, Keith C. Norris, Joel D. Kopple, Mark Unruh, Csaba Kovesdy, Kamyar Kalantar-Zadeh

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Background: Low serum albumin is common and associated with protein-energy wasting, inflammation, and poor outcomes in maintenance hemodialysis (MHD) patients. We hypothesized that in-center (in dialysis clinic) provision of high-protein oral nutrition supplements (ONS) tailored for MHD patients combined with anti-oxidants and anti-inflammatory ingredients with or without an anti-inflammatory appetite stimulator (pentoxifylline, PTX) is well tolerated and can improve serum albumin concentration. Methods: Between January 2008 and June 2010, 84 adult hypoalbuminemic (albumin <4.0 g/dL) MHD outpatients were double-blindly randomized to receive 16 weeks of interventions including ONS, PTX, ONS with PTX, or placebos. Nutritional and inflammatory markers were compared between the four groups. Results: Out of 84 subjects (mean ± SD; age, 59 ± 12 years; vintage, 34 ± 34 months), 32 % were Blacks, 54 % females, and 68 % diabetics. ONS, PTX, ONS plus PTX, and placebo were associated with an average change in serum albumin of +0.21 (P = 0.004), +0.14 (P = 0.008), +0.18 (P = 0.001), and +0.03 g/dL (P = 0.59), respectively. No related serious adverse events were observed. In a predetermined intention-to-treat regression analysis modeling post-trial serum albumin as a function of pre-trial albumin and the three different interventions (ref = placebo), only ONS without PTX was associated with a significant albumin rise (+0.17 ± 0.07 g/dL, P = 0.018). Conclusions: In this pilot-feasibility, 2 × 2 factorial, placebo-controlled trial, daily intake of a CKD-specific high-protein ONS with anti-inflammatory and anti-oxidative ingredients for up to 16 weeks was well tolerated and associated with slight but significant increase in serum albumin levels. Larger long-term controlled trials to examine hard outcomes are indicated.

Original languageEnglish (US)
Pages (from-to)247-257
Number of pages11
JournalJournal of Cachexia, Sarcopenia and Muscle
Volume4
Issue number4
DOIs
StatePublished - Jan 1 2013

Fingerprint

Pentoxifylline
Dialysis
Serum Albumin
Anti-Inflammatory Agents
Randomized Controlled Trials
Placebos
Renal Dialysis
Albumins
Maintenance
Proteins
Intention to Treat Analysis
Appetite
Oxidants
Outpatients
Regression Analysis
Inflammation

All Science Journal Classification (ASJC) codes

  • Orthopedics and Sports Medicine
  • Physiology (medical)

Cite this

Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study : Results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial. / Rattanasompattikul, Manoch; Molnar, Miklos Z.; Lee, Martin L.; Dukkipati, Ramanath; Bross, Rachelle; Jing, Jennie; Kim, Youngmee; Voss, Anne C.; Benner, Debbie; Feroze, Usama; MacDougall, Iain C.; Tayek, John A.; Norris, Keith C.; Kopple, Joel D.; Unruh, Mark; Kovesdy, Csaba; Kalantar-Zadeh, Kamyar.

In: Journal of Cachexia, Sarcopenia and Muscle, Vol. 4, No. 4, 01.01.2013, p. 247-257.

Research output: Contribution to journalArticle

Rattanasompattikul, M, Molnar, MZ, Lee, ML, Dukkipati, R, Bross, R, Jing, J, Kim, Y, Voss, AC, Benner, D, Feroze, U, MacDougall, IC, Tayek, JA, Norris, KC, Kopple, JD, Unruh, M, Kovesdy, C & Kalantar-Zadeh, K 2013, 'Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study: Results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial', Journal of Cachexia, Sarcopenia and Muscle, vol. 4, no. 4, pp. 247-257. https://doi.org/10.1007/s13539-013-0115-9
Rattanasompattikul, Manoch ; Molnar, Miklos Z. ; Lee, Martin L. ; Dukkipati, Ramanath ; Bross, Rachelle ; Jing, Jennie ; Kim, Youngmee ; Voss, Anne C. ; Benner, Debbie ; Feroze, Usama ; MacDougall, Iain C. ; Tayek, John A. ; Norris, Keith C. ; Kopple, Joel D. ; Unruh, Mark ; Kovesdy, Csaba ; Kalantar-Zadeh, Kamyar. / Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study : Results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial. In: Journal of Cachexia, Sarcopenia and Muscle. 2013 ; Vol. 4, No. 4. pp. 247-257.
@article{dd7ed3eed3f74097857ac9c965bec85f,
title = "Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study: Results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial",
abstract = "Background: Low serum albumin is common and associated with protein-energy wasting, inflammation, and poor outcomes in maintenance hemodialysis (MHD) patients. We hypothesized that in-center (in dialysis clinic) provision of high-protein oral nutrition supplements (ONS) tailored for MHD patients combined with anti-oxidants and anti-inflammatory ingredients with or without an anti-inflammatory appetite stimulator (pentoxifylline, PTX) is well tolerated and can improve serum albumin concentration. Methods: Between January 2008 and June 2010, 84 adult hypoalbuminemic (albumin <4.0 g/dL) MHD outpatients were double-blindly randomized to receive 16 weeks of interventions including ONS, PTX, ONS with PTX, or placebos. Nutritional and inflammatory markers were compared between the four groups. Results: Out of 84 subjects (mean ± SD; age, 59 ± 12 years; vintage, 34 ± 34 months), 32 {\%} were Blacks, 54 {\%} females, and 68 {\%} diabetics. ONS, PTX, ONS plus PTX, and placebo were associated with an average change in serum albumin of +0.21 (P = 0.004), +0.14 (P = 0.008), +0.18 (P = 0.001), and +0.03 g/dL (P = 0.59), respectively. No related serious adverse events were observed. In a predetermined intention-to-treat regression analysis modeling post-trial serum albumin as a function of pre-trial albumin and the three different interventions (ref = placebo), only ONS without PTX was associated with a significant albumin rise (+0.17 ± 0.07 g/dL, P = 0.018). Conclusions: In this pilot-feasibility, 2 × 2 factorial, placebo-controlled trial, daily intake of a CKD-specific high-protein ONS with anti-inflammatory and anti-oxidative ingredients for up to 16 weeks was well tolerated and associated with slight but significant increase in serum albumin levels. Larger long-term controlled trials to examine hard outcomes are indicated.",
author = "Manoch Rattanasompattikul and Molnar, {Miklos Z.} and Lee, {Martin L.} and Ramanath Dukkipati and Rachelle Bross and Jennie Jing and Youngmee Kim and Voss, {Anne C.} and Debbie Benner and Usama Feroze and MacDougall, {Iain C.} and Tayek, {John A.} and Norris, {Keith C.} and Kopple, {Joel D.} and Mark Unruh and Csaba Kovesdy and Kamyar Kalantar-Zadeh",
year = "2013",
month = "1",
day = "1",
doi = "10.1007/s13539-013-0115-9",
language = "English (US)",
volume = "4",
pages = "247--257",
journal = "Journal of Cachexia, Sarcopenia and Muscle",
issn = "2190-5991",
publisher = "Springer Verlag",
number = "4",

}

TY - JOUR

T1 - Anti-Inflammatory and Anti-Oxidative Nutrition in Hypoalbuminemic Dialysis Patients (AIONID) study

T2 - Results of the pilot-feasibility, double-blind, randomized, placebo-controlled trial

AU - Rattanasompattikul, Manoch

AU - Molnar, Miklos Z.

AU - Lee, Martin L.

AU - Dukkipati, Ramanath

AU - Bross, Rachelle

AU - Jing, Jennie

AU - Kim, Youngmee

AU - Voss, Anne C.

AU - Benner, Debbie

AU - Feroze, Usama

AU - MacDougall, Iain C.

AU - Tayek, John A.

AU - Norris, Keith C.

AU - Kopple, Joel D.

AU - Unruh, Mark

AU - Kovesdy, Csaba

AU - Kalantar-Zadeh, Kamyar

PY - 2013/1/1

Y1 - 2013/1/1

N2 - Background: Low serum albumin is common and associated with protein-energy wasting, inflammation, and poor outcomes in maintenance hemodialysis (MHD) patients. We hypothesized that in-center (in dialysis clinic) provision of high-protein oral nutrition supplements (ONS) tailored for MHD patients combined with anti-oxidants and anti-inflammatory ingredients with or without an anti-inflammatory appetite stimulator (pentoxifylline, PTX) is well tolerated and can improve serum albumin concentration. Methods: Between January 2008 and June 2010, 84 adult hypoalbuminemic (albumin <4.0 g/dL) MHD outpatients were double-blindly randomized to receive 16 weeks of interventions including ONS, PTX, ONS with PTX, or placebos. Nutritional and inflammatory markers were compared between the four groups. Results: Out of 84 subjects (mean ± SD; age, 59 ± 12 years; vintage, 34 ± 34 months), 32 % were Blacks, 54 % females, and 68 % diabetics. ONS, PTX, ONS plus PTX, and placebo were associated with an average change in serum albumin of +0.21 (P = 0.004), +0.14 (P = 0.008), +0.18 (P = 0.001), and +0.03 g/dL (P = 0.59), respectively. No related serious adverse events were observed. In a predetermined intention-to-treat regression analysis modeling post-trial serum albumin as a function of pre-trial albumin and the three different interventions (ref = placebo), only ONS without PTX was associated with a significant albumin rise (+0.17 ± 0.07 g/dL, P = 0.018). Conclusions: In this pilot-feasibility, 2 × 2 factorial, placebo-controlled trial, daily intake of a CKD-specific high-protein ONS with anti-inflammatory and anti-oxidative ingredients for up to 16 weeks was well tolerated and associated with slight but significant increase in serum albumin levels. Larger long-term controlled trials to examine hard outcomes are indicated.

AB - Background: Low serum albumin is common and associated with protein-energy wasting, inflammation, and poor outcomes in maintenance hemodialysis (MHD) patients. We hypothesized that in-center (in dialysis clinic) provision of high-protein oral nutrition supplements (ONS) tailored for MHD patients combined with anti-oxidants and anti-inflammatory ingredients with or without an anti-inflammatory appetite stimulator (pentoxifylline, PTX) is well tolerated and can improve serum albumin concentration. Methods: Between January 2008 and June 2010, 84 adult hypoalbuminemic (albumin <4.0 g/dL) MHD outpatients were double-blindly randomized to receive 16 weeks of interventions including ONS, PTX, ONS with PTX, or placebos. Nutritional and inflammatory markers were compared between the four groups. Results: Out of 84 subjects (mean ± SD; age, 59 ± 12 years; vintage, 34 ± 34 months), 32 % were Blacks, 54 % females, and 68 % diabetics. ONS, PTX, ONS plus PTX, and placebo were associated with an average change in serum albumin of +0.21 (P = 0.004), +0.14 (P = 0.008), +0.18 (P = 0.001), and +0.03 g/dL (P = 0.59), respectively. No related serious adverse events were observed. In a predetermined intention-to-treat regression analysis modeling post-trial serum albumin as a function of pre-trial albumin and the three different interventions (ref = placebo), only ONS without PTX was associated with a significant albumin rise (+0.17 ± 0.07 g/dL, P = 0.018). Conclusions: In this pilot-feasibility, 2 × 2 factorial, placebo-controlled trial, daily intake of a CKD-specific high-protein ONS with anti-inflammatory and anti-oxidative ingredients for up to 16 weeks was well tolerated and associated with slight but significant increase in serum albumin levels. Larger long-term controlled trials to examine hard outcomes are indicated.

UR - http://www.scopus.com/inward/record.url?scp=84876718554&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84876718554&partnerID=8YFLogxK

U2 - 10.1007/s13539-013-0115-9

DO - 10.1007/s13539-013-0115-9

M3 - Article

VL - 4

SP - 247

EP - 257

JO - Journal of Cachexia, Sarcopenia and Muscle

JF - Journal of Cachexia, Sarcopenia and Muscle

SN - 2190-5991

IS - 4

ER -