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

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.

Conditions

• Pre Diabetes

Interventions

OTHER

DNA-based dietary intervention

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.

OTHER

DNA-based dietary intervention using an app

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.

OTHER

Control arm

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

Sponsors & Collaborators

• DnaNudge Ltd

  collaborator UNKNOWN

• Imperial College London

  lead OTHER

Principal Investigators

• Nick Oliver, M. D. · Imperial College Healthcare NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-26

Primary Completion

2022-10-10

Completion

2022-11-30

Countries

• United Kingdom

Study Locations