Gastro-intestinal tolerance and renal safety of protein oral nutritional supplements in nursing home residents: A randomized controlled trial
Background/Objective High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effec...
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| Veröffentlicht in: | The Journal of nutrition, health & aging health & aging, 2016-11, Vol.20 (9), p.944-951 |
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| creator | Ter Wee, Piet Kuhn, M. van der Woude, H. van de Looverbosch, D. Heyman, H. Mikušová, L. Fouque, D. |
| description | Background/Objective
High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated.
Design
Randomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565).
Setting
Nursing home.
Participants
67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35).
Intervention
Protein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study.
Measurements
Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastrointestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver-and kidney function monitoring.
Results
No clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function.
Conclusion
High protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format. |
| doi_str_mv | 10.1007/s12603-016-0709-y |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_1838212729</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>4246119991</sourcerecordid><originalsourceid>FETCH-LOGICAL-c415t-dc42e1dc09f69fe799c96863f850d62255920a391c3990a68475d3c0b84aeb363</originalsourceid><addsrcrecordid>eNp1UctuFDEQtBCIPOADuCBLnB1sz4wf3KIIAlIkLnC2vHZPcDRjL7bnsPwD_0wvGxAXTt3qqq5WdRHySvArwbl-24RUfGBcKMY1t-zwhJwLrTgbtTFPsZfaMq25PiMXrT1wPk7WqOfkTGpthZTTOfl561uvhaXcofWU_UJ7WaD6HID6HGmF46z5GfqBlpnua-mQMi0Vx3nrNfVUflO2_X6BFXJvFPG81ZbyPf1WVkCRluIReUevKWrHsqYfEGkoGY8vC7Yo5JcX5NnslwYvH-sl-frh_Zebj-zu8-2nm-s7FkYxdRbDKEHEwO2s7Aza2mCVUcNsJh4V-pqs5H6wIgzWcq_MqKc4BL4zo4fdoIZL8uaki26-b2jcPZStoovmhBmMxMdJiyxxYoVaWqswu31Nq68HJ7g7BuBOATgMwB0DcAfcef2ovO1WiH83_nwcCfJEaAjle6j_nP6v6i8y2ZQs</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1838212729</pqid></control><display><type>article</type><title>Gastro-intestinal tolerance and renal safety of protein oral nutritional supplements in nursing home residents: A randomized controlled trial</title><source>MEDLINE</source><source>Alma/SFX Local Collection</source><source>SpringerLink Journals - AutoHoldings</source><creator>Ter Wee, Piet ; Kuhn, M. ; van der Woude, H. ; van de Looverbosch, D. ; Heyman, H. ; Mikušová, L. ; Fouque, D.</creator><creatorcontrib>Ter Wee, Piet ; Kuhn, M. ; van der Woude, H. ; van de Looverbosch, D. ; Heyman, H. ; Mikušová, L. ; Fouque, D.</creatorcontrib><description>Background/Objective
High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated.
Design
Randomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565).
Setting
Nursing home.
Participants
67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35).
Intervention
Protein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study.
Measurements
Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastrointestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver-and kidney function monitoring.
Results
No clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function.
Conclusion
High protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format.</description><identifier>ISSN: 1279-7707</identifier><identifier>EISSN: 1760-4788</identifier><identifier>DOI: 10.1007/s12603-016-0709-y</identifier><identifier>PMID: 27791225</identifier><language>eng</language><publisher>Paris: Springer Paris</publisher><subject>Administration, Oral ; Adult ; Aged ; Aging ; Albuminuria ; Clinical trials ; Compliance ; Creatinine - urine ; Dietary Proteins - administration & dosage ; Dietary Proteins - adverse effects ; Dietary supplements ; Dietary Supplements - adverse effects ; Energy ; Female ; Gastrointestinal Diseases - chemically induced ; Geriatrics/Gerontology ; Glomerular Filtration Rate ; Humans ; Kidney Diseases - chemically induced ; Kidneys ; Male ; Medicine ; Medicine & Public Health ; Middle Aged ; Nephrology ; Neurosciences ; Nursing Homes ; Nutrition ; Older people ; Primary Care Medicine ; Proteins ; Quality of Life Research ; Renal Insufficiency, Chronic ; Single-Blind Method</subject><ispartof>The Journal of nutrition, health & aging, 2016-11, Vol.20 (9), p.944-951</ispartof><rights>Serdi and Springer-Verlag France 2016</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c415t-dc42e1dc09f69fe799c96863f850d62255920a391c3990a68475d3c0b84aeb363</citedby><cites>FETCH-LOGICAL-c415t-dc42e1dc09f69fe799c96863f850d62255920a391c3990a68475d3c0b84aeb363</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s12603-016-0709-y$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12603-016-0709-y$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27923,27924,41487,42556,51318</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27791225$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ter Wee, Piet</creatorcontrib><creatorcontrib>Kuhn, M.</creatorcontrib><creatorcontrib>van der Woude, H.</creatorcontrib><creatorcontrib>van de Looverbosch, D.</creatorcontrib><creatorcontrib>Heyman, H.</creatorcontrib><creatorcontrib>Mikušová, L.</creatorcontrib><creatorcontrib>Fouque, D.</creatorcontrib><title>Gastro-intestinal tolerance and renal safety of protein oral nutritional supplements in nursing home residents: A randomized controlled trial</title><title>The Journal of nutrition, health & aging</title><addtitle>J Nutr Health Aging</addtitle><addtitle>J Nutr Health Aging</addtitle><description>Background/Objective
High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated.
Design
Randomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565).
Setting
Nursing home.
Participants
67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35).
Intervention
Protein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study.
Measurements
Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastrointestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver-and kidney function monitoring.
Results
No clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function.
Conclusion
High protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format.</description><subject>Administration, Oral</subject><subject>Adult</subject><subject>Aged</subject><subject>Aging</subject><subject>Albuminuria</subject><subject>Clinical trials</subject><subject>Compliance</subject><subject>Creatinine - urine</subject><subject>Dietary Proteins - administration & dosage</subject><subject>Dietary Proteins - adverse effects</subject><subject>Dietary supplements</subject><subject>Dietary Supplements - adverse effects</subject><subject>Energy</subject><subject>Female</subject><subject>Gastrointestinal Diseases - chemically induced</subject><subject>Geriatrics/Gerontology</subject><subject>Glomerular Filtration Rate</subject><subject>Humans</subject><subject>Kidney Diseases - chemically induced</subject><subject>Kidneys</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Nephrology</subject><subject>Neurosciences</subject><subject>Nursing Homes</subject><subject>Nutrition</subject><subject>Older people</subject><subject>Primary Care Medicine</subject><subject>Proteins</subject><subject>Quality of Life Research</subject><subject>Renal Insufficiency, Chronic</subject><subject>Single-Blind Method</subject><issn>1279-7707</issn><issn>1760-4788</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp1UctuFDEQtBCIPOADuCBLnB1sz4wf3KIIAlIkLnC2vHZPcDRjL7bnsPwD_0wvGxAXTt3qqq5WdRHySvArwbl-24RUfGBcKMY1t-zwhJwLrTgbtTFPsZfaMq25PiMXrT1wPk7WqOfkTGpthZTTOfl561uvhaXcofWU_UJ7WaD6HID6HGmF46z5GfqBlpnua-mQMi0Vx3nrNfVUflO2_X6BFXJvFPG81ZbyPf1WVkCRluIReUevKWrHsqYfEGkoGY8vC7Yo5JcX5NnslwYvH-sl-frh_Zebj-zu8-2nm-s7FkYxdRbDKEHEwO2s7Aza2mCVUcNsJh4V-pqs5H6wIgzWcq_MqKc4BL4zo4fdoIZL8uaki26-b2jcPZStoovmhBmMxMdJiyxxYoVaWqswu31Nq68HJ7g7BuBOATgMwB0DcAfcef2ovO1WiH83_nwcCfJEaAjle6j_nP6v6i8y2ZQs</recordid><startdate>20161101</startdate><enddate>20161101</enddate><creator>Ter Wee, Piet</creator><creator>Kuhn, M.</creator><creator>van der Woude, H.</creator><creator>van de Looverbosch, D.</creator><creator>Heyman, H.</creator><creator>Mikušová, L.</creator><creator>Fouque, D.</creator><general>Springer Paris</general><general>Springer Nature B.V</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88G</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2M</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PSYQQ</scope><scope>Q9U</scope></search><sort><creationdate>20161101</creationdate><title>Gastro-intestinal tolerance and renal safety of protein oral nutritional supplements in nursing home residents: A randomized controlled trial</title><author>Ter Wee, Piet ; Kuhn, M. ; van der Woude, H. ; van de Looverbosch, D. ; Heyman, H. ; Mikušová, L. ; Fouque, D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c415t-dc42e1dc09f69fe799c96863f850d62255920a391c3990a68475d3c0b84aeb363</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Administration, Oral</topic><topic>Adult</topic><topic>Aged</topic><topic>Aging</topic><topic>Albuminuria</topic><topic>Clinical trials</topic><topic>Compliance</topic><topic>Creatinine - urine</topic><topic>Dietary Proteins - administration & dosage</topic><topic>Dietary Proteins - adverse effects</topic><topic>Dietary supplements</topic><topic>Dietary Supplements - adverse effects</topic><topic>Energy</topic><topic>Female</topic><topic>Gastrointestinal Diseases - chemically induced</topic><topic>Geriatrics/Gerontology</topic><topic>Glomerular Filtration Rate</topic><topic>Humans</topic><topic>Kidney Diseases - chemically induced</topic><topic>Kidneys</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Nephrology</topic><topic>Neurosciences</topic><topic>Nursing Homes</topic><topic>Nutrition</topic><topic>Older people</topic><topic>Primary Care Medicine</topic><topic>Proteins</topic><topic>Quality of Life Research</topic><topic>Renal Insufficiency, Chronic</topic><topic>Single-Blind Method</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ter Wee, Piet</creatorcontrib><creatorcontrib>Kuhn, M.</creatorcontrib><creatorcontrib>van der Woude, H.</creatorcontrib><creatorcontrib>van de Looverbosch, D.</creatorcontrib><creatorcontrib>Heyman, H.</creatorcontrib><creatorcontrib>Mikušová, L.</creatorcontrib><creatorcontrib>Fouque, D.</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Psychology Database (Alumni)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Psychology Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest One Psychology</collection><collection>ProQuest Central Basic</collection><jtitle>The Journal of nutrition, health & aging</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ter Wee, Piet</au><au>Kuhn, M.</au><au>van der Woude, H.</au><au>van de Looverbosch, D.</au><au>Heyman, H.</au><au>Mikušová, L.</au><au>Fouque, D.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Gastro-intestinal tolerance and renal safety of protein oral nutritional supplements in nursing home residents: A randomized controlled trial</atitle><jtitle>The Journal of nutrition, health & aging</jtitle><stitle>J Nutr Health Aging</stitle><addtitle>J Nutr Health Aging</addtitle><date>2016-11-01</date><risdate>2016</risdate><volume>20</volume><issue>9</issue><spage>944</spage><epage>951</epage><pages>944-951</pages><issn>1279-7707</issn><eissn>1760-4788</eissn><abstract>Background/Objective
High protein oral nutritional supplements (ONS) are regularly prescribed to undernourished patients; however usage of these in older adults is being discussed, as their renal function might have declined with age. Therefore, the aim of the current study was to evaluate the effects of 8 week long consumption of high protein ONS on the renal function of nursing home residents in need of supplementation. Furthermore, within the same setup, differences in gastro-intestinal tolerance between a standard and a more concentrated version of an ONS were investigated.
Design
Randomized, controlled, single-blind, parallel-group, multi-country trial (NTR2565).
Setting
Nursing home.
Participants
67 nursing home residents in need of ONS (energy-dense, small volume group n=32; standard volume group n=35).
Intervention
Protein supplementation was provided by either a standard (200ml, 300kcal, 20g protein) or an energy-dense, small volume (125ml, 300kcal, 18g protein) ONS during the 8 week long study.
Measurements
Primary outcome was gastro-intestinal tolerance, assessed by daily stool frequency and consistency, and occurrence and intensity of self-reported gastrointestinal symptoms. Safety was measured via the occurrence of (serious) adverse events, vital signs, as well as liver-and kidney function monitoring.
Results
No clinically relevant and, except for flatulence, no statistically significant differences in gastro-intestinal tolerance were observed between groups. No significant difference between groups was found for estimated glomerular filtration rate (eGFR) and urinary albumin/creatinine ratio at baseline and week 8, nor for the changes from baseline. Adverse events and the changes in monitored renal parameters over the study period did not point to a deterioration of renal function.
Conclusion
High protein ONS seems to be well-tolerated and safe; there is no indication that it affects renal function in nursing home residents, including patients with stage 3 chronic kidney disease, under the conditions tested. Results did not suggest a difference in the effect on renal function between standard and energy-dense small volume ONS format.</abstract><cop>Paris</cop><pub>Springer Paris</pub><pmid>27791225</pmid><doi>10.1007/s12603-016-0709-y</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1279-7707 |
| ispartof | The Journal of nutrition, health & aging, 2016-11, Vol.20 (9), p.944-951 |
| issn | 1279-7707 1760-4788 |
| language | eng |
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| subjects | Administration, Oral Adult Aged Aging Albuminuria Clinical trials Compliance Creatinine - urine Dietary Proteins - administration & dosage Dietary Proteins - adverse effects Dietary supplements Dietary Supplements - adverse effects Energy Female Gastrointestinal Diseases - chemically induced Geriatrics/Gerontology Glomerular Filtration Rate Humans Kidney Diseases - chemically induced Kidneys Male Medicine Medicine & Public Health Middle Aged Nephrology Neurosciences Nursing Homes Nutrition Older people Primary Care Medicine Proteins Quality of Life Research Renal Insufficiency, Chronic Single-Blind Method |
| title | Gastro-intestinal tolerance and renal safety of protein oral nutritional supplements in nursing home residents: A randomized controlled trial |
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