Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation
ASPIRE-DNA
1 other identifier
interventional
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2018
CompletedFirst Posted
Study publicly available on registry
October 11, 2018
CompletedStudy Start
First participant enrolled
November 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedDecember 1, 2022
November 1, 2022
3.9 years
October 5, 2018
November 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in glucose regulation between the control and intervention arm
Difference in 0 minutes glucose on 75g oral glucose tolerance test between the control arm and the intervention arm.
6 weeks
Secondary Outcomes (26)
120 minutes glucose on 75g oral glucose tolerance test
6, 12 and 26 weeks
0 minutes glucose on 75g oral glucose tolerance test
6, 12 and 26 weeks
Concentration of glycated haemoglobin in blood
12 and 26 weeks
Weight
6, 12 and 26 weeks
BMI
6, 12 and 26 weeks
- +21 more secondary outcomes
Study Arms (3)
Control Arm
ACTIVE COMPARATORPre-diabetic participants will receive general health guidelines according to the NICE guidelines, as per standard care. These will be delivered via an initial consultation with a dietitian. Participants in the control group will receive 2 follow up phone calls from the dietitian to answer any questions they may have during the study.
Intervention Arm
ACTIVE COMPARATORDNA-based dietary intervention: participants will receive DNA-based health guidelines via a genetic report. These will be delivered via an initial consultation with a dietitian. Participants in the control group will receive 2 follow up phone calls from the dietitian to answer any questions they may have during the study.
Exploratory Arm
EXPERIMENTALDNA-based dietary intervention using an app: participants will receive DNA-based health guidelines via the DnaNudge App.
Interventions
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.
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.
Standard care for pre-diabetic individuals: dietary advice as per the NICE guidelines for individuals who have pre-diabetes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- DnaNudge Ltdcollaborator
Study Sites (1)
Imperial Clinical Research Facility
London, W12 0HS, United Kingdom
Related Publications (1)
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.
PMID: 38443427DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Oliver, M. D.
Imperial College Healthcare NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2018
First Posted
October 11, 2018
Study Start
November 26, 2018
Primary Completion
October 10, 2022
Study Completion
November 30, 2022
Last Updated
December 1, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share