Pre DiabetesASPIRE-DNANCT03702465
Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation
A study testing DNA-based dietary intervention and DNA-based dietary intervention using an app in people with Pre Diabetes, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- DNA-based dietary intervention and DNA-based dietary intervention using an app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Nov 2018to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Diabetic
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial Clinical Research Facility
London, W12 0HS
About this study
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.
Read the 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.
- Conditions
- Pre Diabetes
- Being tested
- DNA-based dietary intervention, DNA-based dietary intervention using an app, Control arm
- Keywords
- Type 2 Diabetes, DNA-based diet, App
- Medical subject headings
- Glucose Intolerance, Diabetes Mellitus, Type 2, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA-based dietary interventionOther
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.
DNA-based dietary intervention using an appOther
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.
Control armOther
Standard care for pre-diabetic individuals: dietary advice as per the NICE guidelines for individuals who have pre-diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | 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. Receives: Other: Control arm |
| Intervention Arm | Active comparator | 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. Receives: Other: DNA-based dietary intervention |
| Exploratory Arm | Experimental | DNA-based dietary intervention using an app: participants will receive DNA-based health guidelines via the DnaNudge App. Receives: Other: DNA-based dietary intervention using an app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (26)
120 minutes glucose on 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.
Measured: 6, 12 and 26 weeks
0 minutes glucose on 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.
Measured: 6, 12 and 26 weeks
Concentration of glycated haemoglobin 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 12 and 26 weeks.
Measured: 12 and 26 weeks
Weight
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.
Measured: 6, 12 and 26 weeks
BMI
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.
Measured: 6, 12 and 26 weeks
Lean mass
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.
Measured: 6, 12 and 26 weeks
Fat mass
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.
Measured: 6, 12 and 26 weeks
Waist circumference
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.
Measured: 6, 12 and 26 weeks
Measurement of total cholesterol 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.
Measured: 6, 12 and 26 weeks
Measurement of fasting triglycerides 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.
Measured: 6, 12 and 26 weeks
Measurement of LDL cholesterol 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.
Measured: 6, 12 and 26 weeks
Measurement of HDL cholesterol 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.
Measured: 6, 12 and 26 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
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.
Measured: 6, 12 and 26 weeks
Measurement of 120 minute c-peptide
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.
Measured: 6, 12 and 26 weeks
Systolic blood pressure
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.
Measured: 6, 12 and 26 weeks
Diastolic blood pressure
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.
Measured: 6,12 and 26 weeks
Dietary intake
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.
Measured: 6,12 and 26 weeks
Energy intake from a food frequency questionnaire
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.
Measured: 6,12 and 26 weeks
Carbohydrate intake from a food frequency questionnaire
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.
Measured: 6, 12 and 26 weeks
Fat intake from a food frequency questionnaire
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.
Measured: 6, 12 and 26 weeks
Saturated fat intake from a food frequency questionnaire
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.
Measured: 6, 12 and 26 weeks
Salt intake from a food frequency questionnaire
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.
Measured: 6,12 and 26 weeks
Concentration of Vitamin D 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.
Measured: 6, 12 and 26 weeks
Concentration of Vitamin B6 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.
Measured: 6, 12 and 26 weeks
Vitamin B12 from a food frequency questionnaire
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.
Measured: 6, 12 and 26 weeks
Number of participant withdrawals in the trial
Number of participant withdrawals in the trial
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start26 Nov 2018
- Primary completion10 Oct 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel assignment with an active control
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- DnaNudge Ltd
- Responsible party
- Sponsor
- Investigators
- Nick Oliver, M. D., Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702465
- Sponsor's protocol ID
- 18HH4629
- Acronym
- ASPIRE-DNA
- Status last verified
- Nov 2022
- First submitted
- 5 Oct 2018
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 38443427
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of a Personalised Nutrition Intervention in Impaired Glucose Regulation
- ClinicalTrials.gov ID
- NCT03702465
- Acronym / sponsor ID
- ASPIRE-DNA / 18HH4629
- Conditions
- Pre Diabetes
- Keywords
- Type 2 Diabetes, DNA-based diet, App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- DnaNudge Ltd
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel assignment with an active control
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Other: Control armPre-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 comparator | Other: DNA-based dietary interventionDNA-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 | Experimental | Other: DNA-based dietary intervention using an appDNA-based dietary intervention using an app: participants will receive DNA-based health guidelines via the DnaNudge App. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Diabetic
- Pregnant or planning pregnancy
- Breastfeeding
- Enrolled in other clinical trials
- Have active malignancy or under investigation for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA-based dietary interventionThe 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 | Intervention Arm |
| DNA-based dietary intervention using an appThe 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 | Exploratory Arm |
| Control armStandard care for pre-diabetic individuals: dietary advice as per the NICE guidelines for individuals who have pre-diabetes. | Other | Control Arm |
Primary outcome
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.
26 secondary outcomes
120 minutes glucose on 75g oral glucose tolerance test
Time frame: 6, 12 and 26 weeks
0 minutes glucose on 75g oral glucose tolerance test
Time frame: 6, 12 and 26 weeks
Concentration of glycated haemoglobin in blood
Time frame: 12 and 26 weeks
Weight
Time frame: 6, 12 and 26 weeks
BMI
Time frame: 6, 12 and 26 weeks
Lean mass
Time frame: 6, 12 and 26 weeks
Fat mass
Time frame: 6, 12 and 26 weeks
Waist circumference
Time frame: 6, 12 and 26 weeks
Measurement of total cholesterol in blood
Time frame: 6, 12 and 26 weeks
Measurement of fasting triglycerides in blood
Time frame: 6, 12 and 26 weeks
Measurement of LDL cholesterol in blood
Time frame: 6, 12 and 26 weeks
Measurement of HDL cholesterol in blood
Time frame: 6, 12 and 26 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Time frame: 6, 12 and 26 weeks
Measurement of 120 minute c-peptide
Time frame: 6, 12 and 26 weeks
Systolic blood pressure
Time frame: 6, 12 and 26 weeks
Diastolic blood pressure
Time frame: 6,12 and 26 weeks
Dietary intake
Time frame: 6,12 and 26 weeks
Energy intake from a food frequency questionnaire
Time frame: 6,12 and 26 weeks
Carbohydrate intake from a food frequency questionnaire
Time frame: 6, 12 and 26 weeks
Fat intake from a food frequency questionnaire
Time frame: 6, 12 and 26 weeks
Saturated fat intake from a food frequency questionnaire
Time frame: 6, 12 and 26 weeks
Salt intake from a food frequency questionnaire
Time frame: 6,12 and 26 weeks
Concentration of Vitamin D in blood
Time frame: 6, 12 and 26 weeks
Concentration of Vitamin B6 in blood
Time frame: 6, 12 and 26 weeks
Vitamin B12 from a food frequency questionnaire
Time frame: 6, 12 and 26 weeks
Number of participant withdrawals in the trial
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2022.
- Derived from this study: PubMed 38443427Karvela 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.
- ASPIRE-DNA Clinical Trial WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Oliver, M. D. principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DNA-based dietary intervention and DNA-based dietary intervention using an app in people with Pre Diabetes, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in glucose regulation between the control and intervention arm (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03702465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2022.