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
Hauptverfasser: Kamphuis, P. J. G. H., Verhey, F. R. J., Olde Rikkert, M. G. M., Twisk, J. W. R., Swinkels, S. H. N., Scheltens, Philip
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container_issue 8
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container_title The Journal of nutrition, health & aging
container_volume 15
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
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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. 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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 &amp; 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. 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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 &amp; 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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