Trial reportInternational journal of molecular sciences2016
Effect of a Prebiotic Formulation on Frailty Syndrome: A Randomized, Double-Blind Clinical Trial.
Trial report in International journal of molecular sciences, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 132 papers, 13 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
132 citing papers in PubMed, 13 syntheses or guidelines pooled it, 212 citations in OpenAlex.
- Gut microbiome modulation can improve cognitive function in older adults: a systematic review and meta-analysis.Age and ageing · 2026Pooled it
- Effect of host and gut microbiota-altering interventions on sarcopenia or its defining parameters: a systematic review and meta-analysis of nutrition-based intervention studies.Aging clinical and experimental research · 2025Pooled it
- Evaluating the Role of Probiotics, Prebiotics, and Synbiotics Supplementation in Age-related Musculoskeletal Disorders in Older Adults: A Systematic Review.Probiotics and antimicrobial proteins · 2025Pooled it
- Effects of Probiotics, Prebiotics, and Synbiotics on Sarcopenia Parameters in Older Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Nutrition reviews · 2025Pooled it
- The Relationship Between Gut Microbiota, Muscle Mass and Physical Function in Older Individuals: A Systematic Review.Nutrients · 2024Pooled it
- Association between Drug Therapy and Risk of Incident Frailty: A Systematic Review.Annals of geriatric medicine and research · 2024Pooled it
- Probiotics supplementation or probiotic-fortified products on sarcopenic indices in older adults: systematic review and meta-analysis from recent randomized controlled trials.Frontiers in aging · 2024Pooled it
- The effect of gut microbiome-targeted therapies in nonalcoholic fatty liver disease: a systematic review and network meta-analysis.Frontiers in nutrition · 2024Pooled it
- Validity of food additive maltodextrin as placebo and effects on human gut physiology: systematic review of placebo-controlled clinical trials.European journal of nutrition · 2022Pooled it
- Understanding the gut microbiota and sarcopenia: a systematic review.Journal of cachexia, sarcopenia and muscle · 2021Pooled it
- Microbiota shaping - the effects of probiotics, prebiotics, and fecal microbiota transplant on cognitive functions: A systematic review.World journal of gastroenterology · 2021Pooled it
- The Effects of Pro-, Pre-, and Synbiotics on Muscle Wasting, a Systematic Review-Gut Permeability as Potential Treatment Target.Nutrients · 2021Pooled it
- Effectiveness of interventions to prevent pre-frailty and frailty progression in older adults: a systematic review.JBI database of systematic reviews and implementation reports · 2018Pooled it
- Effects of Phenolic-Rich Extra Virgin Olive Oil and Prebiotics on Sarcopenia in Older Adults: FOOP-Sarc Project.Journal of cachexia, sarcopenia and muscle · 2026Trial
- Preliminary clinical study on the synergistic effects of prebiotics and β-hydroxy-β-methylbutyrate in improving muscle function and intestinal barrier function in elderly patients with sarcopenia.Aging clinical and experimental research · 2026Trial
- Prebiotics improve frailty status in community-dwelling older individuals in a double-blind, randomized, controlled trial.The Journal of clinical investigation · 2024Trial
- Probiotics Supplements Improve the Sarcopenia-Related Quality of Life in Older Adults with Age-Related Muscle Decline.Calcified tissue international · 2024Trial
- Effect of gut microbiome modulation on muscle function and cognition: the PROMOTe randomised controlled trial.Nature communications · 2024Trial
- Eight Weeks ofNutrients · 2023Trial
- Trial
72 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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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.