Effect of a 1-Year Nutritional Blend Supplementation on Plasma p-tau181 and GFAP Levels among Community-Dwelling Older Adults: A Secondary Analysis of the Nolan Trial

K V Giudici; P de Souto Barreto; S Guyonnet; C Cantet; H Zetterberg; C Boschat; J Hudry; S Andrieu; J A J Schmitt; B Vellas; K Blennow; NOLAN/DSA group

doi:10.14283/jarlife.2023.7

Effect of a 1-Year Nutritional Blend Supplementation on Plasma p-tau181 and GFAP Levels among Community-Dwelling Older Adults: A Secondary Analysis of the Nolan Trial

JAR Life. 2023 Jun 12:12:25-34. doi: 10.14283/jarlife.2023.7. eCollection 2023.

Authors

K V Giudici¹, P de Souto Barreto^{1

2}, S Guyonnet^{1

2}, C Cantet^{1

2}, H Zetterberg^{3

4

5

6

7

8}, C Boschat⁹, J Hudry⁹, S Andrieu^{2

10}, J A J Schmitt^{9

11

12}, B Vellas^{1

2}, K Blennow^{3

4}; NOLAN/DSA group

Affiliations

¹ Gerontopole of Toulouse, Institute of Ageing, Toulouse University Hospital (CHU Toulouse), Toulouse, France.
² CERPOP UMR1295, University of Toulouse III, Inserm, UPS, Toulouse, France.
³ Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, the Sahlgrenska Academy at University of Gothenburg, Mölndal, Sweden.
⁴ Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal, Sweden.
⁵ Department of Neurodegenerative Disease, UCL Institute of Neurology, Queen Square, London, United Kingdom.
⁶ UK Dementia Research Institute at UCL, London, United Kingdom.
⁷ Hong Kong Center for Neurodegenerative Diseases, Clear Water Bay, Hong Kong, China.
⁸ Wisconsin Alzheimer's Disease Research Center, University of Wisconsin School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, USA.
⁹ Brain Health Department, Nestlé Institute of Health Sciences, Nestlé Research, Société des Produits Nestlé S.A., 1000 Lausanne, Switzerland.
¹⁰ Department of Epidemiology and Public Health, Toulouse University Hospital (CHU Toulouse), Toulouse, France.
¹¹ Singapore Institute of Food and Biotechnology Innovation (SIFBI), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.
¹² Singapore Institute for Clinical Sciences (SICS), Agency for Science, Technology and Research (A*STAR), Singapore, Singapore.

Abstract

Background: Observational studies and some randomized controlled trials have suggested that nutritional supplementation could be a possible intervention pathway to prevent cognitive decline and Alzheimer's disease (AD). As measuring amyloid-β and tau pathophysiology by positron emission tomography (PET) or cerebrospinal fluid (CSF) analyses may be perceived as complex, plasma versions of such biomarkers have emerged as more accessible alternatives with comparable capacity of predicting cognitive impairment.

Objectives: This study aimed to evaluate the effect of a 1-year intervention with a nutritional blend on plasma p-tau181 and glial fibrillary acidic protein (GFAP) levels in community-dwelling older adults. Effects were further assessed in exploratory analyses within sub-cohorts stratified according to p-tau status (with the third tertile considered as high: ≥15.1 pg/ mL) and to apolipoprotein E (APOE) ε4 allele status.

Methods: A total of 289 participants ≥70 years (56.4% female, mean age 78.1 years, SD=4.7) of the randomized, double-blind, multicenter, placebo-controlled Nolan trial had their plasma p-tau181 assessed, and daily took either a nutritional blend (composed of thiamin, riboflavin, niacin, pantothenic acid, pyridoxine, biotin, folic acid, cobalamin, vitamin E, vitamin C, vitamin D, choline, selenium, citrulline, eicosapentaenoic acid - EPA, and docosahexaenoic acid - DHA) or placebo for 1 year.

Results: After 1-year, both groups presented a significant increase in plasma p-tau181 and GFAP values, with no effect of the intervention (p-tau181 between-group difference: 0.27pg/mL, 95%CI: -0.95, 1.48; p=0.665; GFAP between-group difference: -3.28 pg/mL, 95%CI: -17.25, 10.69; p=0.644). P-tau-and APOE ε4-stratified analyses provided similar findings.

Conclusions: In community-dwelling older adults, we observed an increase in plasma p-tau181 and GFAP levels that was not different between the supplementation groups after one year.

Keywords: Alzheimer; clinical trials; cognitive decline; nutrition; p-tau.

Grants and funding

Funding statement: The global sponsor of the Nolan Study is Société des Produits Nestlé SA, Nestlé Research, Lausanne, Switzerland. The sponsor for France is the University Hospital Center of Toulouse. The study sponsor was involved in study center set-up and monitoring, preparation and distribution of BPB and placebo, data collection and monitoring working closely with the investigators. Initial training sessions and yearly investigator’s meeting were organized by both the University Hospital Center of Toulouse and Nestlé. The data sharing activity was supported by the Association Monegasque pour la Recherche sur la maladie d’Alzheimer (AMPA) and the INSERM-University of Toulouse III UMR 1027 research unit.