Trial reportThe journal of nutrition, health & aging2011
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.
Trial report in The journal of nutrition, health & aging, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
11 citing papers in PubMed, 4 syntheses or guidelines pooled it, 33 citations in OpenAlex.
- The effects of omega-3, DHA, EPA, Souvenaid® in Alzheimer's disease: A systematic review and meta-analysis.Neuropsychopharmacology reports · 2024Pooled it
- Souvenaid for Alzheimer's disease.The Cochrane database of systematic reviews · 2020Pooled it
- The potential role of nutritional components in improving brain function among patients with Alzheimers disease: a meta-analysis of RCT studies.Neurosciences (Riyadh, Saudi Arabia) · 2020Pooled it
- Efficacy of Mealtime Interventions for Malnutrition and Oral Intake in Persons With Dementia: A Systematic Review.Alzheimer disease and associated disordersPooled it
- Dietary interventions in mild cognitive impairment and dementia.Dialogues in clinical neuroscience · 2019Review
- Weight Loss in Patients with Dementia: Considering the Potential Impact of Pharmacotherapy.Drugs & aging · 2017Review
- A practical algorithm for managing Alzheimer's disease: what, when, and why?Annals of clinical and translational neurology · 2015Review
- Souvenaid®: a new approach to management of early Alzheimer's disease.The journal of nutrition, health & aging · 2014Article
- Frailty and cognition: linking two common syndromes in older persons.The journal of nutrition, health & aging · 2013Article
- Nutritional status of community-dwelling elderly with newly diagnosed Alzheimer's disease: prevalence of malnutrition and the relation of various factors to nutritional status.The journal of nutrition, health & aging · 2013Article
- Use of medical foods and nutritional approaches in the treatment of Alzheimer's disease.Clinical practice (London, England) · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo 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.
resultsOverall, 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).
conclusionsThese data indicate that baseline BMI significantly impacts the effect of Souvenaid on functional abilities. In addition, there was a suggestion that Souvenaid increased BMI.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.