Protein and Skeletal Muscle in Older Twins: Role of the Gut Microbiome
Condition: Sarcopenia; Frailty; Age-Related Sarcopenia
MeSH terms: Sarcopenia; Frailty
Study type: Interventional

Summary: 
      Research Question: Does the gut microbiome contribute to muscle anabolic resistance to
      protein supplementation in older adults?

      Background: Loss of muscle occurs with age and skeletal muscle in older adults can display
      anabolic resistance to protein in diet. It has been hypothesised that the gut microbiome may
      play a role in this relationship and therefore could be targeted.

      Aim:

      This trial aims to test whether modulation of the gut microbiome, in addition to protein
      supplementation, can improve skeletal muscle function versus protein supplementation alone.

      Methods:

      Double blinded, randomised, placebo controlled, dietary intervention study. Twin pairs will
      be randomised to either receive protein supplementation plus placebo or protein
      supplementation plus a gut microbiome modulator (prebiotic plus probiotic) for 12 weeks.
      Primary outcome will be muscle function measured using chair-rise time.

      Conclusion:

      Anabolic resistance warrants further characterisation to guide future therapeutic
      interventions, especially considering its role in the development of disability, sarcopenia
      and frailty.
    

Detailed description: 
      Research Question: Does the gut microbiome contribute to muscle anabolic resistance to
      protein supplementation in older adults?

      Background: Loss of skeletal muscle mass and strength occurs with increasing age and is
      associated with loss of function, disability, and the development of sarcopenia and frailty.
      Dietary protein is essential for skeletal muscle function, but older adults do not respond as
      well as younger people to protein, so called 'anabolic resistance'. The aetiology and
      molecular mechanisms for this are not understood, however a number have been proposed. The
      gut microbiome is known to play a key role in a number of these postulated mechanisms. This
      has led us to hypothesise that the gut microbiome may mediate anabolic resistance and could
      represent an exciting new target for ameliorating muscle loss in older adults.

      Aim:

      This trial aims to test whether modulation of the gut microbiome, in addition to protein
      supplementation, can improve skeletal muscle function versus protein supplementation alone.

      Methods:

      Double blinded, randomised, placebo controlled, dietary intervention study. Volunteers will
      be recruited in twin pairs from TwinsUK cohort, for which extensive baseline data are
      available. The twin nature of the study allows for close genetic and environmental matching
      at baseline. Each pair will be randomised to either receive protein supplementation plus
      placebo or protein supplementation plus a gut microbiome modulator (prebiotic plus
      probiotic). Intervention period will be 12 weeks. Clinical and biochemical measures will be
      taken at 0, and 12 weeks, with 2-monthly contact. Gut microbiota composition will be
      measured, alongside a battery of physical assessments. Primary outcome will be muscle
      function measured using chair-rise time. The trial will be delivered remotely using video
      calls, and postal boxes.

      Conclusion:

      Anabolic resistance warrants further characterisation to guide future therapeutic
      interventions, especially considering its role in the development of disability, sarcopenia
      and frailty. Therapeutic options are badly needed, particularly for older adults who cannot
      undertake exercise programmes.
    

Intervention name(s): Prebiotic food supplement; Protein supplement; Maltrodextrin (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Darmocare Pre = trade name Gut microbiome modulator; commercially available protein supplementation with high leucine content; Starchy substance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: gut microbiome; metabolome; prebiotic