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Clean food, gut bacteria, and drug effects: Is diet another variable drug development?

Posted on March 9th, 2017 by in Pharma R&D

Gut bacteria

There has been quite a lot of press coverage in the UK recently regarding clean eating, and a variety of recipes and websites offering advice are becoming quite popular. Even the British Broadcasting Association, who define clean eating as using wholesome and non-processed foods, makes some suggestions (1). I understand that several perspectives on eating for health are currently in vogue. There is also now a considerable variety in what we can eat, when we have a choice. Within my own family and friends, I see a number of preferences including vegetarians, vegans, people who will eat fish but not meat, and people who will not eat red meat.

A focus on diet and well being can be an important part of balanced and healthy diet, but for some people the focus on control of their diet can develop into more than a passion or preference. Orthorexia is an unhealthy obsession with eating foods thought to be healthy. It is not a recognized condition within the DSM-5, although it seems to have the potential to negatively impact peoples’ lives (2). No doubt there is a growing focus and realization of the impact of diet on health that affects our behaviours to a variety of degrees. Diet is considered a risk factor for conditions such as Multiple Sclerosis, and lifestyle choices maybe front of mind for many people. In a recent publication (3) of 601 individuals with Multiple Sclerosis, 17 % stated they were modulating their diet for managing their symptoms and over 85% would be prepared to change diet for three months or longer.

Our associations with food are therefore perhaps another factor that will make a difference in the real-world use of medicines. Within a clinical trial it might be possible to assess and monitor diet and other lifestyle factors, but once in a real-world situation, this will become more problematic. Time of year, motivations, and mindsets may all exert an influence on our diet, and it might be difficult to imagine how this can impact our physiology. It is probably not a simple relationship, as diet is just one factor influencing our wellbeing and biological status.

Sarkar and colleagues recently outlined the effects of manipulation of GI bacterial colonies. They compared the effects of probiotic (live bacteria) and prebiotic substrates that lead to the generation of beneficial gut bacteria in animal and human studies. Agents that modulate the gut micro-environment can have effects on hormone release, systemic inflammatory status, and the hypothalamic-pituitary axis modulating the stress response. A systems view would suggest that the microbiome certainly has the potential to modulate psycho-physiological responses, behaviour, and drug action. However, these workers also point out a number of gaps and beliefs that the realization of the true translational understanding of the role of these type of agents will require detailed mechanistic investigation.

There is no doubt that this is a complex field, and true predictive understanding may not be achievable for a rapidly changing system. However, it seems that the impact of diet can rapidly and reproducibly change the human gut biome (5). With Christmas a recent memory, I am sure my diet changed considerably over the last 4-6 weeks. How this impacted my physiological and biochemical system is unknown. However, with the potential to change inflammatory and stress responses, it seems these changes in diet could contribute to some significant variability in my physiological and psychological status. The impact of lifestyle factors may be difficult to control and understand. Lifestyle behaviors are also difficult to measure with accuracy. Self-reported diet sheets may not reflect actual behavior. However, the impact of diet is a potential blind spot for patients, clinicians, and researchers, and in the ever-increasing complexity of real world use, a systems view might be an approach to increase our understanding of enablers and disablers of not only health and wellbeing but also medicine safety and efficacy.

  3. Brenton and Goldman (2016), Multiple Sclerosis and Related Disorders. 8: 54–57
  4. Sarker et al., (2016), Trends in Neurosciences 39:763-781
  5. David et al, (2014), Nature 505: 559-563



All opinions shared in this post are the author’s own.

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