Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial.
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.
Department of Nursing, University of Valencia, Valencia 46010, Spain. cristina.buigues@uv.es.
Cristina
C
Buigues
Department of Nursing, University of Valencia, Valencia 46010, Spain. julio.fernandez@uv.es.
Julio
J
Fernández-Garrido
Natura Foundation, Numansdorp 3281 NC, The Netherlands. cpni.pruimboom@icloud.com.|University of Groningen, University Medical Center Groningen (UMCG), Groningen 9712 CP, The Netherlands. cpni.pruimboom@icloud.com.
Leo
L
Pruimboom
Bonusan Besloten Vennootschap, Numansdorp 3280 AA, The Netherlands. a.hoogland@bonusan.nl.
Aldert J
AJ
Hoogland
Department of Nursing, University of Valencia, Valencia 46010, Spain. rut.navarro@uv.es.
Rut
R
Navarro-Martínez
GeroResidencias La Saleta, Valencia 46015, Spain. mmartinez@lasaleta.com.
Mary
M
Martínez-Martínez
GeroResidencias La Saleta, Valencia 46015, Spain. supelpuig@saleta.com.
Yolanda
Y
Verdejo
GeroResidencias La Saleta, Valencia 46015, Spain. supcampolivar@saleta.com.
Mari Carmen
MC
Mascarós
GeroResidencias La Saleta, Valencia 46015, Spain. betera@lasaleta.com.
Carlos
C
Peris
Department of Nursing, University of Valencia, Valencia 46010, Spain. omar.cauli@uv.es.
Omar
O
Cauli
D000368:Aged; D000369:Aged, 80 and over; D003071:Cognition; D004311:Double-Blind Method; D005221:Fatigue / Q000178:diet therapy / Q000188:drug therapy*; D005260:Female; D016330:Frail Elderly; D015577:Geriatric Assessment; D018737:Hand Strength; D006801:Humans; D007444:Inulin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D056692:Prebiotics / Q000008:administration & dosage / Q000009:adverse effects*; D055948:Sarcopenia / Q000178:diet therapy / Q000188:drug therapy*; D012890:Sleep
D056692:Prebiotics; D007444:Inulin
aging; biomarker; fatigue; inflammation; leucocytes