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Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation (ASPIRE-DNA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03702465
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : December 11, 2019
Sponsor:
Collaborator:
DnaNudge Ltd
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Pre Diabetes Other: DNA-based dietary intervention Other: DNA-based dietary intervention using an app Other: Control arm Not Applicable

Detailed Description:

Diabetes is amongst the most common long term conditions, with the number of people affected worldwide quadrupling from 108 million in 1980 to 422 million in 2014. Its prevalence in people over 18 years of age has risen from 4.7% in 1980 to a staggering 8.5% in 2014. In 2012, there were 1.5 million deaths as a direct result of diabetes, making it the 8th leading cause of death amongst both sexes, and the 5th leading cause of death amongst women. There were a further 2.2 million deaths as a result of complications due to higher-than-optimal glucose levels. In 2013, 6% of the UK adult population (2.7 million people) were diabetic, 90% of whom had type 2 diabetes. A further 5 million people were estimated to be at high risk of developing type 2 diabetes. This has led to a cost of £8 billion per year to the NHS, 80% of which is due to diabetes-related complications such as cardiovascular disease, amputations, renal failure and sight loss.

The standard treatment protocol for pre-diabetic individuals in the UK is a brief consultation with their clinician highlighting the dangers of an increased risk of diabetes, and some general information regarding healthy eating and the benefits of regular physical activity. The individual will subsequently be contacted every 3 years to assess the state of their glucose regulation. Despite the implementation of this system, incidence rates of diabetes have continued to rise over the years. From 1994-2011, the number of women diagnosed with diabetes has risen from 1.9 - 4.9%, and 2.9 - 7.0% for men. In response to this, the NHS launched the NHS Diabetes Prevention Program (DPP) in 2016. The aforementioned studies and the predictions of the DPP are in agreement that an intensive lifestyle intervention can radically reduce incidence rates of diabetes. However, these interventions are costly, labour-intensive and require the health system to pre-identify pre-diabetic patients. The latter is one of the greatest challenges to any diabetes prevention program, as many at-risk individuals will not self-assess to pre-empt a glucose regulation test.

The investigator's solution aims to assess the improvement in glucose regulation by following a DNA-based diet in comparison with the standard protocol. The DNA-based diet will be devised based on metabolism-based genotypic traits of the participant. The traits cover metabolic imbalances such as carbohydrate sensitivity and fat sensitivity. This nutrigenetic information will be supplied to the user in an easy to use electronic format to provide food recommendations on demand during grocery shopping e.g. via the DnaNudge App or other visual indicator.

If effective, this solution could provide a cost-effective, widely-distributed, easily scalable prevention tool for improving glucose regulation in high risk individuals. Moreover, the non-invasive nature of the intervention, paired with the autonomy that it provides the individual in choosing their food choices, enables it to be a low-risk intervention. Furthermore, as a DNA-based diet is relevant for the general public, it has the potential to perform the preventative measures on individuals who do not self-identify as pre-diabetic.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment with an active control
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation
Actual Study Start Date : November 26, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
Active Comparator: Control Arm
Pre-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.
Other: Control arm
Standard care for pre-diabetic individuals: dietary advice as per the NICE guidelines for individuals who have pre-diabetes.

Active Comparator: Intervention Arm
DNA-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.
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.

Experimental: Exploratory Arm
DNA-based dietary intervention using an app: participants will receive DNA-based health guidelines via the DnaNudge App.
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.




Primary Outcome Measures :
  1. Difference in glucose regulation between the control and intervention arm [ Time Frame: 6 weeks ]
    Difference in 0 minutes glucose on 75g oral glucose tolerance test between the control arm and the intervention arm.


Secondary Outcome Measures :
  1. 120 minutes glucose on 75g oral glucose tolerance test [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  2. 0 minutes glucose on 75g oral glucose tolerance test [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  3. Concentration of glycated haemoglobin in blood [ Time Frame: 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 12 and 26 weeks.

  4. Weight [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  5. BMI [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  6. Lean mass [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  7. Fat mass [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  8. Waist circumference [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  9. Measurement of total cholesterol in blood [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  10. Measurement of fasting triglycerides in blood [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  11. Measurement of LDL cholesterol in blood [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  12. Measurement of HDL cholesterol in blood [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  13. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [ Time Frame: 6, 12 and 26 weeks ]
    Derived from measurements of insulin and glucose in blood. Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  14. Measurement of 120 minute c-peptide [ Time Frame: 6, 12 and 26 weeks ]
    Measured after a 75g oral glucose tolerance test. Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  15. Systolic blood pressure [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  16. Diastolic blood pressure [ Time Frame: 6,12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  17. Dietary intake [ Time Frame: 6,12 and 26 weeks ]
    Dietary intake will be assessed using 24-hours recall questionnaire (food frequency questionnaire [FFQ]) at visits 4, 5, 7, 9 and 11. Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  18. Energy intake from a food frequency questionnaire [ Time Frame: 6,12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  19. Carbohydrate intake from a food frequency questionnaire [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  20. Fat intake from a food frequency questionnaire [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  21. Saturated fat intake from a food frequency questionnaire [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  22. Salt intake from a food frequency questionnaire [ Time Frame: 6,12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  23. Concentration of Vitamin D in blood [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  24. Concentration of Vitamin B6 in blood [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  25. Vitamin B12 from a food frequency questionnaire [ Time Frame: 6, 12 and 26 weeks ]
    Cross-arm and within arm differences (compared to 0 week measurements) between the control arm, intervention arm, and the exploratory arm, measured at 6, 12 and 26 weeks.

  26. Number of participant withdrawals in the trial [ Time Frame: 26 weeks ]
    Number of participant withdrawals in the trial



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702465


Contacts
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Contact: Caroline Golden, PhD 07428755051 caroline.golden11@imperial.ac.uk
Contact: Nick Oliver, M.D. +44 (0)20 3313 1593 nick.oliver@imperial.ac.uk

Locations
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United Kingdom
Imperial Clinical Research Facility Recruiting
London, United Kingdom, W12 0HS
Contact: Karen Mosley, PhD    +44 (0)20 3313 8073    Karen.Mosley@imperial.nhs.uk   
Contact: Suzanne Fagerbrink    020 3313 8077    Susanne.Fagerbrink@imperial.nhs.uk   
Principal Investigator: Nick Oliver, M. D.         
Sponsors and Collaborators
Imperial College London
DnaNudge Ltd
Investigators
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Principal Investigator: Nick Oliver, M. D. Imperial College Healthcare NHS Trust
  Study Documents (Full-Text)

Documents provided by Imperial College London:
Study Protocol  [PDF] July 16, 2018
Statistical Analysis Plan  [PDF] October 19, 2018

Additional Information:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03702465    
Other Study ID Numbers: 18HH4629
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 2 Diabetes
DNA-based diet
App
Additional relevant MeSH terms:
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Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases