Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from a randomized, controlled trial
Objectives To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer’s disease (AD). Design/setting/participants/intervention /measurements These analyses were performed on data from a 12-week, double-blind, randomized,...
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Veröffentlicht in: | The Journal of nutrition, health & aging health & aging, 2011-08, Vol.15 (8), p.672-676 |
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creator | Kamphuis, P. J. G. H. Verhey, F. R. J. Olde Rikkert, M. G. M. Twisk, J. W. R. Swinkels, S. H. N. Scheltens, Philip |
description | Objectives
To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer’s disease (AD).
Design/setting/participants/intervention /measurements
These analyses were performed on data from a 12-week, double-blind, randomized, controlled, multicenter, proof-of-concept study with a similarly designed and exploratory 12-week extension period. Patients with mild AD (Mini-Mental State Examination score of 20–26) were randomized to receive either the active product or an iso-caloric control product While primary outcomes included measures of cognition, the 23-item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale was included as a secondary outcome. Both ADCS-ADL and BMI were assessed at baseline and Weeks 6, 12 and 24. Data were analyzed using a repeated-measures mixed model.
Results
Overall, data suggested an increased BMI in the active versus the control group at Week 24 (ITT: p = 0.07; PP: p = 0.03), but no treatment effect on ADCS-ADL was observed. However, baseline BMI was found to be a significant treatment effect modifier (ITT: p = 0.04; PP: p = 0.05), and an increase in ADCS-ADL was observed at Week 12 in patients with a ‘low’ baseline BMI (ITT: p = 0.02; PP: p = 0.04).
Conclusions
These data indicate that baseline BMI significantly impacts the effect of Souvenaid on functional abilities. In addition, there was a suggestion that Souvenaid increased BMI. |
doi_str_mv | 10.1007/s12603-011-0339-3 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_journals_921024956</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2583770631</sourcerecordid><originalsourceid>FETCH-LOGICAL-c413t-382249ad30408c8a3ccd7c5bd1bb6238fcdccda3abe346aa5087733103cb584b3</originalsourceid><addsrcrecordid>eNp1kU1uFDEQhS0EIiFwADaoxJoGu93ddrOLovAjRWIBrK1q2504crcH2xOYrLgGR-BanIQaTYAVK1tV33tV9mPsqeAvBefqVRHtwGXDhWi4lGMj77FjoQbedErr-3Rv1dgoxdURe1TKNeddP-rhITtqxThoPchj9vN8nr2tkGZAWLwLFiPMKTlIK0zJ7WDBUiCszn8DXB2greEm1ODLXuMwxB1EqqyXBMEGqbPWAl9DvYLTeHvlw-Lzr-8_CrhQPBb_Gj56m1aHeUeGGHeFrOacFlog04S0hFvvXgAxNacYvYOaA8bH7MGMsfgnd-cJ-_zm_NPZu-biw9v3Z6cXje2ErI3UbduN6CTvuLYapbVO2X5yYpqGVurZOqqgxMnLbkDsuVZKSsGlnXrdTfKEPT_4bnL6svWlmuu0zbRoMWMrOJn3A0HiANmcSsl-NpscFnqSEdzsszGHbAxlY_bZGEmaZ3fG24l--q_iTxgEtAegUGu99Pnf5P-7_gaEc52u</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>921024956</pqid></control><display><type>article</type><title>Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from a randomized, controlled trial</title><source>MEDLINE</source><source>SpringerLink Journals</source><source>Alma/SFX Local Collection</source><creator>Kamphuis, P. J. G. H. ; Verhey, F. R. J. ; Olde Rikkert, M. G. M. ; Twisk, J. W. R. ; Swinkels, S. H. N. ; Scheltens, Philip</creator><creatorcontrib>Kamphuis, P. J. G. H. ; Verhey, F. R. J. ; Olde Rikkert, M. G. M. ; Twisk, J. W. R. ; Swinkels, S. H. N. ; Scheltens, Philip</creatorcontrib><description>Objectives
To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer’s disease (AD).
Design/setting/participants/intervention /measurements
These analyses were performed on data from a 12-week, double-blind, randomized, controlled, multicenter, proof-of-concept study with a similarly designed and exploratory 12-week extension period. Patients with mild AD (Mini-Mental State Examination score of 20–26) were randomized to receive either the active product or an iso-caloric control product While primary outcomes included measures of cognition, the 23-item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale was included as a secondary outcome. Both ADCS-ADL and BMI were assessed at baseline and Weeks 6, 12 and 24. Data were analyzed using a repeated-measures mixed model.
Results
Overall, data suggested an increased BMI in the active versus the control group at Week 24 (ITT: p = 0.07; PP: p = 0.03), but no treatment effect on ADCS-ADL was observed. However, baseline BMI was found to be a significant treatment effect modifier (ITT: p = 0.04; PP: p = 0.05), and an increase in ADCS-ADL was observed at Week 12 in patients with a ‘low’ baseline BMI (ITT: p = 0.02; PP: p = 0.04).
Conclusions
These data indicate that baseline BMI significantly impacts the effect of Souvenaid on functional abilities. In addition, there was a suggestion that Souvenaid increased BMI.</description><identifier>ISSN: 1279-7707</identifier><identifier>EISSN: 1760-4788</identifier><identifier>DOI: 10.1007/s12603-011-0339-3</identifier><identifier>PMID: 21968863</identifier><language>eng</language><publisher>Paris: Springer-Verlag</publisher><subject>Activities of Daily Living ; Aged ; Aged, 80 and over ; Aging ; Alzheimer Disease - diet therapy ; Alzheimer's disease ; Body Mass Index ; Cognition & reasoning ; Cognition - drug effects ; Dietary Supplements ; Double-Blind Method ; Effect of a Medical Food on BMI and ADL ; Female ; Geriatric Assessment ; Geriatrics/Gerontology ; Humans ; Male ; Medicine ; Medicine & Public Health ; Micronutrients - pharmacology ; Micronutrients - therapeutic use ; Neurosciences ; Nutrition ; Primary Care Medicine ; Quality of Life Research ; Weight Gain - drug effects</subject><ispartof>The Journal of nutrition, health & aging, 2011-08, Vol.15 (8), p.672-676</ispartof><rights>Serdi and Springer Verlag France 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c413t-382249ad30408c8a3ccd7c5bd1bb6238fcdccda3abe346aa5087733103cb584b3</citedby><cites>FETCH-LOGICAL-c413t-382249ad30408c8a3ccd7c5bd1bb6238fcdccda3abe346aa5087733103cb584b3</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/s12603-011-0339-3$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s12603-011-0339-3$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,41488,42557,51319</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21968863$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kamphuis, P. J. G. H.</creatorcontrib><creatorcontrib>Verhey, F. R. J.</creatorcontrib><creatorcontrib>Olde Rikkert, M. G. M.</creatorcontrib><creatorcontrib>Twisk, J. W. R.</creatorcontrib><creatorcontrib>Swinkels, S. H. N.</creatorcontrib><creatorcontrib>Scheltens, Philip</creatorcontrib><title>Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from 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>Objectives
To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer’s disease (AD).
Design/setting/participants/intervention /measurements
These analyses were performed on data from a 12-week, double-blind, randomized, controlled, multicenter, proof-of-concept study with a similarly designed and exploratory 12-week extension period. Patients with mild AD (Mini-Mental State Examination score of 20–26) were randomized to receive either the active product or an iso-caloric control product While primary outcomes included measures of cognition, the 23-item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale was included as a secondary outcome. Both ADCS-ADL and BMI were assessed at baseline and Weeks 6, 12 and 24. Data were analyzed using a repeated-measures mixed model.
Results
Overall, data suggested an increased BMI in the active versus the control group at Week 24 (ITT: p = 0.07; PP: p = 0.03), but no treatment effect on ADCS-ADL was observed. However, baseline BMI was found to be a significant treatment effect modifier (ITT: p = 0.04; PP: p = 0.05), and an increase in ADCS-ADL was observed at Week 12 in patients with a ‘low’ baseline BMI (ITT: p = 0.02; PP: p = 0.04).
Conclusions
These data indicate that baseline BMI significantly impacts the effect of Souvenaid on functional abilities. In addition, there was a suggestion that Souvenaid increased BMI.</description><subject>Activities of Daily Living</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Aging</subject><subject>Alzheimer Disease - diet therapy</subject><subject>Alzheimer's disease</subject><subject>Body Mass Index</subject><subject>Cognition & reasoning</subject><subject>Cognition - drug effects</subject><subject>Dietary Supplements</subject><subject>Double-Blind Method</subject><subject>Effect of a Medical Food on BMI and ADL</subject><subject>Female</subject><subject>Geriatric Assessment</subject><subject>Geriatrics/Gerontology</subject><subject>Humans</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Micronutrients - pharmacology</subject><subject>Micronutrients - therapeutic use</subject><subject>Neurosciences</subject><subject>Nutrition</subject><subject>Primary Care Medicine</subject><subject>Quality of Life Research</subject><subject>Weight Gain - drug effects</subject><issn>1279-7707</issn><issn>1760-4788</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</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>eNp1kU1uFDEQhS0EIiFwADaoxJoGu93ddrOLovAjRWIBrK1q2504crcH2xOYrLgGR-BanIQaTYAVK1tV33tV9mPsqeAvBefqVRHtwGXDhWi4lGMj77FjoQbedErr-3Rv1dgoxdURe1TKNeddP-rhITtqxThoPchj9vN8nr2tkGZAWLwLFiPMKTlIK0zJ7WDBUiCszn8DXB2greEm1ODLXuMwxB1EqqyXBMEGqbPWAl9DvYLTeHvlw-Lzr-8_CrhQPBb_Gj56m1aHeUeGGHeFrOacFlog04S0hFvvXgAxNacYvYOaA8bH7MGMsfgnd-cJ-_zm_NPZu-biw9v3Z6cXje2ErI3UbduN6CTvuLYapbVO2X5yYpqGVurZOqqgxMnLbkDsuVZKSsGlnXrdTfKEPT_4bnL6svWlmuu0zbRoMWMrOJn3A0HiANmcSsl-NpscFnqSEdzsszGHbAxlY_bZGEmaZ3fG24l--q_iTxgEtAegUGu99Pnf5P-7_gaEc52u</recordid><startdate>201108</startdate><enddate>201108</enddate><creator>Kamphuis, P. J. G. H.</creator><creator>Verhey, F. R. J.</creator><creator>Olde Rikkert, M. G. M.</creator><creator>Twisk, J. W. R.</creator><creator>Swinkels, S. H. N.</creator><creator>Scheltens, Philip</creator><general>Springer-Verlag</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>201108</creationdate><title>Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from a randomized, controlled trial</title><author>Kamphuis, P. J. G. H. ; Verhey, F. R. J. ; Olde Rikkert, M. G. M. ; Twisk, J. W. R. ; Swinkels, S. H. N. ; Scheltens, Philip</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c413t-382249ad30408c8a3ccd7c5bd1bb6238fcdccda3abe346aa5087733103cb584b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Activities of Daily Living</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Aging</topic><topic>Alzheimer Disease - diet therapy</topic><topic>Alzheimer's disease</topic><topic>Body Mass Index</topic><topic>Cognition & reasoning</topic><topic>Cognition - drug effects</topic><topic>Dietary Supplements</topic><topic>Double-Blind Method</topic><topic>Effect of a Medical Food on BMI and ADL</topic><topic>Female</topic><topic>Geriatric Assessment</topic><topic>Geriatrics/Gerontology</topic><topic>Humans</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Micronutrients - pharmacology</topic><topic>Micronutrients - therapeutic use</topic><topic>Neurosciences</topic><topic>Nutrition</topic><topic>Primary Care Medicine</topic><topic>Quality of Life Research</topic><topic>Weight Gain - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kamphuis, P. J. G. H.</creatorcontrib><creatorcontrib>Verhey, F. R. J.</creatorcontrib><creatorcontrib>Olde Rikkert, M. G. M.</creatorcontrib><creatorcontrib>Twisk, J. W. R.</creatorcontrib><creatorcontrib>Swinkels, S. H. N.</creatorcontrib><creatorcontrib>Scheltens, Philip</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>Kamphuis, P. J. G. H.</au><au>Verhey, F. R. J.</au><au>Olde Rikkert, M. G. M.</au><au>Twisk, J. W. R.</au><au>Swinkels, S. H. N.</au><au>Scheltens, Philip</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from 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>2011-08</date><risdate>2011</risdate><volume>15</volume><issue>8</issue><spage>672</spage><epage>676</epage><pages>672-676</pages><issn>1279-7707</issn><eissn>1760-4788</eissn><abstract>Objectives
To investigate the effect of a medical food (Souvenaid) on body mass index (BMI) and functional abilities in patients with mild Alzheimer’s disease (AD).
Design/setting/participants/intervention /measurements
These analyses were performed on data from a 12-week, double-blind, randomized, controlled, multicenter, proof-of-concept study with a similarly designed and exploratory 12-week extension period. Patients with mild AD (Mini-Mental State Examination score of 20–26) were randomized to receive either the active product or an iso-caloric control product While primary outcomes included measures of cognition, the 23-item Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale was included as a secondary outcome. Both ADCS-ADL and BMI were assessed at baseline and Weeks 6, 12 and 24. Data were analyzed using a repeated-measures mixed model.
Results
Overall, data suggested an increased BMI in the active versus the control group at Week 24 (ITT: p = 0.07; PP: p = 0.03), but no treatment effect on ADCS-ADL was observed. However, baseline BMI was found to be a significant treatment effect modifier (ITT: p = 0.04; PP: p = 0.05), and an increase in ADCS-ADL was observed at Week 12 in patients with a ‘low’ baseline BMI (ITT: p = 0.02; PP: p = 0.04).
Conclusions
These data indicate that baseline BMI significantly impacts the effect of Souvenaid on functional abilities. In addition, there was a suggestion that Souvenaid increased BMI.</abstract><cop>Paris</cop><pub>Springer-Verlag</pub><pmid>21968863</pmid><doi>10.1007/s12603-011-0339-3</doi><tpages>5</tpages><oa>free_for_read</oa></addata></record> |
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subjects | Activities of Daily Living Aged Aged, 80 and over Aging Alzheimer Disease - diet therapy Alzheimer's disease Body Mass Index Cognition & reasoning Cognition - drug effects Dietary Supplements Double-Blind Method Effect of a Medical Food on BMI and ADL Female Geriatric Assessment Geriatrics/Gerontology Humans Male Medicine Medicine & Public Health Micronutrients - pharmacology Micronutrients - therapeutic use Neurosciences Nutrition Primary Care Medicine Quality of Life Research Weight Gain - drug effects |
title | Effect of a medical food on body mass index and activities of daily living in patients with Alzheimer’s disease: Secondary analyses from a randomized, controlled trial |
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