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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


Kamphuis, P. J. G. H., Verhey, F. R. J., Olde Rikkert, M. G. M., Twisk, J. W. R., Swinkels, S. H. N., Scheltens, P.


The Journal Of Nutrition, Health & Aging, Volume: 15, No.: 8, Pages.: 672-676

Year of Publication



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.;


activities of daily living, aged, aged, 80 and over, alzheimer disease, body mass index, cognition, diet therapy, dietary supplements, double-blind method, drug effects, female, geriatric assessment, humans, male, micronutrients, pharmacology, souvenaid, therapeutic use, weight gain

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes

ADLs/IADLs, Cognition, Physical Health

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Herbal remedies, vitamins, dietary supplements