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Be Part of Research - Trial Details - Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation

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

Completed

Open to: ALL

Age: 18.0 - N/A

Medical Conditions

Pre Diabetes


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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 United Kingdom 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. 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 individuals with pre-diabetes. 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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Nov 2018 Oct 2022

Publications

"Karvela M, Golden CT, Bell N, Martin-Li S, Bedzo-Nutakor J, Bosnic N, DeBeaudrap P, de Mateo-Lopez S, Alajrami A, Qin Y, Eze M, Hon TK, Simon-Sanchez J, Sahoo R, Pearson-Stuttard J, Soon-Shiong P, Toumazou C, Oliver N. Assessment of the impact of a personalised nutrition intervention in impaired glucose regulation over 26 weeks: a randomised controlled trial. Sci Rep. 2024 Mar 5;14(1):5428. doi: 10.1038/s41598-024-55105-6."; "38443427"

INTERVENTIONAL

Intervention Type : OTHER
Intervention Description : The DNA for all arms of the study will be analysed for pre-determined single nucleotide polymorphisms (SNPs) relevant to metabolism. Participants in the intervention arm, will be provided with a hard-copy of a genetic report, which will explain how their SNPs influence their dietary habits.

Intervention Arm Group : Intervention Arm;

Intervention Type : OTHER
Intervention Description : The DNA for all arms of the study will be analysed for pre-determined single nucleotide polymorphisms (SNPs) relevant to metabolism. Participants in the exploratory arm, will be given personalised DNA-based dietary advice via the DnaNudge App.

Intervention Arm Group : Exploratory Arm;

Intervention Type : OTHER
Intervention Description : Standard care for pre-diabetic individuals: dietary advice as per the NICE guidelines for individuals who have pre-diabetes.

Intervention Arm Group : Control Arm;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Imperial Clinical Research Facility
    London
    W12 0HS


The study is sponsored by Imperial College London and is in collaboration with DnaNudge Ltd.





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Read full details for Trial ID: NCT03702465
Last updated 30 November 2022

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