Personalised Nutrition Intervention in Impaired GlucoseRegulationV0.18

• Research type

  Research Study

• Full title

  Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation

• IRAS ID

  237699

• Contact name

  Nick Oliver

• Contact email

  nick.oliver@imperial.ac.uk

• Sponsor organisation

  Joint Research and Compliance Office

• Clinicaltrials.gov Identifier

  NCT03702465

• Duration of Study in the UK

  1 years, 10 months, 23 days

• Research summary

  Summary of Research
  This study will determine if DNA-based dietary guidelines can improve glucose regulation in pre-diabetic individuals significantly more than standard dietary guidelines following 6 weeks of the intervention. This will be assessed using an oral glucose tolerance test, which is a standard clinical measurement used to assess impaired glucose regulation. Pre-diabetic individuals will be recruited by offering the opportunity to self-assess their risk score for type 2 diabetes using the Leicester Risk Score Questionnaire on the Diabetes UK website, and they can contact the clinical trial team if they are interested in participating in the trial. They will then be invited for a point of care Hba1c test to determine their suitability for the trial. The point of care Hba1c test is a simple finger prick test to assess glucose regulation.

  The potential for lifestyle interventions to reduce the progression to type 2 diabetes from pre-diabetic states has been demonstrated in a number of randomised control trials (RCTs) in different countries, with a meta-analysis of RCTs suggesting that lifestyle intervention in high risk subjects can halve the incidence of diabetes. However, they have been expensive and labour intensive, with multiple personal contacts. Such intensive input is not practical on a large scale. Furthermore, DNA based dietary advice has shown a greater improvement in fasting glucose measurements in obese individuals compared to standard dietary advice, with the BMI (body mass index) only showing a long-term improvement in the group that received DNA-based dietary advice. The proposed study may be able to show that increased benefits can be obtained by following a DNA-based diet compared to standard dietary advice for pre-diabetic patients. Furthermore, the exploratory arm of the study will receive the advice via an app (provided by DnaNudge Ltd), which if effective, would demonstrate a low-cost, widely-distributable method that could be deployed to the general public without requiring individuals to self-identify as pre-diabetic to receive an intervention. The research is funded by DnaNudge Ltd.

  Summary of Results
  : The ASPIRE-DNA study provides evidence that increased benefits can be obtained by following a DNA-personalised diet compared to standard dietary advice for individuals with pre- diabetes. Both DNA-based arms (intervention and exploratory), presented with a significant reduction in Fasting plasma glucose (FPG)( measurement of blood sugar) over 6 months compared to standard care, as well as other health outcomes such as significantly reduced HbA1c( measure of blood glucose) and systolic blood pressure (intervention arm). This demonstrates the efficacy of a DNA-personalised intervention in the participants’ management of blood sugar. Furthermore, the data demonstrated that the exploratory arm, where participants were self-guided via the DnaNudge app and wearable device, presented with a significant clinical improvement compared to the control arm that followed NICE guidelines delivered on a one to-one basis by a dietitian. The improved FPG decrease over time in the exploratory arm was achieved faster than in the intervention arm, where DNA-personalised dietary advice was also delivered by a dietitian on a one-to-one basis. This is very promising as it suggests that the selfguided use of the DnaNudge app and wearable could potentially provide a low-cost, widely distributable method that could be deployed to the public without requiring individuals to self-identity as having IGR(Impaired glucose regulation) to receive an intervention. This is particularly important as it demonstrates a real-world application of a personalised and self-guided intervention (DnaNudge app) which has scope to be rolled out nationally without adding huge burden to the NHS and whilst giving people a greater sense of health autonomy

• REC name

  North of Scotland Research Ethics Committee 2

• REC reference

  18/NS/0093

• Date of REC Opinion

  18 Sep 2018

• REC opinion

  Further Information Favourable Opinion