Effect of gut microbiome modulation on muscle function and cognition: the PROMOTe randomised controlled trial
What this study found
The prebiotic improved cognition versus placebo, but it did not improve the primary muscle outcome of chair rise time or other muscle-strength outcomes over 12 weeks. Chair rise time changed from 10.38 to 9.49 seconds in the prebiotic group versus 10.24 to 9.12 seconds in placebo, with no treatment effect (β = 0.579; 95% CI -1.080 to 2.239; p = 0.494). Cognition factor score improved more with prebiotic than placebo (β = -0.482; 95% CI -0.813 to -0.141; p = 0.014). The intervention also increased Bifidobacterium and microbiome features correlated with cognition and muscle-related measures.
- Study & population
- Randomized controlled trial in older adults aged 60 years or older from the TwinsUK cohort, using a twin-pair 1:1 design with one twin allocated to prebiotic and the matched twin to placebo.
- Intervention
- The active regimen was a prebiotic sachet, Darmocare Pre, at 7.5 g/day for 12 weeks, taken once daily and mixed in water or another drink.
- Key limitation
- The active arm was small, with only 36 participants receiving the prebiotic, and follow-up was short at 12 weeks.
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Open PDFOriginal abstract
Studies suggest that inducing gut microbiota changes may alter both muscle physiology and cognitive behaviour. Gut microbiota may play a role in both anabolic resistance of older muscle, and cognition. In this placebo controlled double blinded randomised controlled trial of 36 twin pairs (72 individuals), aged ≥60, each twin pair are block randomised to receive either placebo or prebiotic daily for 12 weeks. Resistance exercise and branched chain amino acid (BCAA) supplementation is prescribed to all participants. Outcomes are physical function and cognition. The trial is carried out remotely using video visits, online questionnaires and cognitive testing, and posting of equipment and biological samples. The prebiotic supplement is well tolerated and results in a changed gut microbiome [e.g., increased relative Bifidobacterium abundance]. There is no significant difference between prebiotic and placebo for the primary outcome of chair rise time (β = 0.579; 95% CI −1.080-2.239 p = 0.494). The prebiotic improves cognition (factor score versus placebo (β = −0.482; 95% CI,−0.813, −0.141; p = 0.014)). Our results demonstrate that cheap and readily available gut microbiome interventions may improve cognition in our ageing population. We illustrate the feasibility of remotely delivered trials for older people, which could reduce under-representation of older people in clinical trials. ClinicalTrials.gov registration: NCT04309292. Here, the authors present the results of the PROMOTe trial, reporting improved cognition with prebiotic vs placebo in twins over 60 years old, probing that remote trials are feasible in older adults, and suggesting that the gut microbiota may represent a therapeutic target for age-associated morbidity.