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Open AccessArticle

Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial

Department of Nursing, University of Valencia, Valencia 46010, Spain
Natura Foundation, Numansdorp 3281 NC, The Netherlands
University of Groningen, University Medical Center Groningen (UMCG), Groningen 9712 CP, The Netherlands
Bonusan Besloten Vennootschap, Numansdorp 3280 AA, The Netherlands
GeroResidencias La Saleta, Valencia 46015, Spain
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Academic Editors: Antonio Segura-Carretero and Ana Maria Gómez Caravaca
Int. J. Mol. Sci. 2016, 17(6), 932;
Received: 25 March 2016 / Revised: 1 June 2016 / Accepted: 2 June 2016 / Published: 14 June 2016
(This article belongs to the Special Issue Advances in Molecular Research of Functional and Nutraceutical Food)
PDF [417 KB, uploaded 14 June 2016]


Aging can result in major changes in the composition and metabolic activities of bacterial populations in the gastrointestinal system and result in impaired function of the immune system. We assessed the efficacy of prebiotic Darmocare Pre® (Bonusan Besloten Vennootschap (BV), Numansdorp, The Netherlands) to evaluate whether the regular intake of this product can improve frailty criteria, functional status and response of the immune system in elderly people affected by the frailty syndrome. The study was a placebo-controlled, randomized, double blind design in sixty older participants aged 65 and over. The prebiotic product was composed of a mixture of inulin plus fructooligosaccharides and was compared with placebo (maltodextrin). Participants were randomized to a parallel group intervention of 13 weeks’ duration with a daily intake of Darmocare Pre® or placebo. Either prebiotic or placebo were administered after breakfast (between 9–10 a.m.) dissolved in a glass of water carefully stirred just before drinking. The primary outcome was to study the effect on frailty syndrome. The secondary outcomes were effect on functional and cognitive behavior and sleep quality. Moreover, we evaluated whether prebiotic administration alters blood parameters (haemogram and biochemical analysis). The overall rate of frailty was not significantly modified by Darmocare Pre® administration. Nevertheless, prebiotic administration compared with placebo significantly improved two frailty criteria, e.g., exhaustion and handgrip strength (p < 0.01 and p < 0.05, respectively). No significant effects were observed in functional and cognitive behavior or sleep quality. The use of novel therapeutic approaches influencing the gut microbiota–muscle–brain axis could be considered for treatment of the frailty syndrome. View Full-Text
Keywords: fatigue; biomarker; leucocytes; inflammation; aging fatigue; biomarker; leucocytes; inflammation; aging

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Buigues, C.; Fernández-Garrido, J.; Pruimboom, L.; Hoogland, A.J.; Navarro-Martínez, R.; Martínez-Martínez, M.; Verdejo, Y.; Mascarós, M.C.; Peris, C.; Cauli, O. Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial. Int. J. Mol. Sci. 2016, 17, 932.

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