CompletedNot Applicable

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

United Kingdom180 participantsStarted 2018-11-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Provision of signed and dated informed consent form * Adults over 18 years of age * Impaired glucose regulation including impaired fasting glucose (IFG) and impaired glucose tolerance (IGT) by fasting glucose, oral glucose tolerance test (OGTT) or HbA1c criteria * Access to smart phone with an operating system of iOS 8.0 or above, or Android 4.0 or above. Exclusion Criteria: * Diabetic * Pregnant or planning pregnancy * Breastfeeding * Enrolled in other clinical trials * Have active malignancy or under investigation for malignancy * Severe visual impairment * Reduced manual dexterity * Use of psychiatric, anti-diabetic, and/or weight loss medication, and/or oral steroids * Bariatric surgery * History of illnesses that could interfere with the interpretation of the study results (e.g. HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, alcohol or substance abuse) * Unable to participate due to other factors, as assessed by the Chief Investigator

What they're measuring

Difference in glucose regulation between the control and intervention arm

Timeframe: 6 weeks

Trial details

NCT IDNCT03702465

SponsorImperial College London

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-10