DiabeteseNONCT04866264
Electronic-Nutrition-Optimizer for Personalized Prevention
A study testing eNutrition Optimizer in people with Diabetes and Hypertension, run by Heike Bischoff-Ferrari at 1 site in Switzerland.
Trial summary
This study aims to develop and validate a tool for immediate nutrition assessment and to test its user feasibility in routine clinical practice for health promotion. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Hypertension, Frailty
- What is being tested?
- eNutrition Optimizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 Nov 2021to 23 May 2024
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group)
- Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group)
- ≥50 years
Who cannot join
- If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded
- People with an impaired short-term memory (MMSE <24)
- Patients following a specific diet recommended by a medical professional, due to diseases such as diabetes, chronic diseases of the gastrointestinal tract, severe kidney disease, or patients allergic to the main components of the Mediterranean diet/MINDdiet (olive oil, nuts)
- Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM
- BMI > 30 kg/m2
- Individuals per se not willing to change diet
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- Instable clinical conditions (e.g. acute infection) at enrolment
- Patients with active cancer (except non-melanoma skin cancer) or current cancer treatment or any other advanced severe disease
- Living in a nursing home and/or receiving prepared meals (i.e. usually not eating home cooked meals)
- Inability to read and or speak German necessary to understand the instructions
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre on Aging and Mobility, University of Zurich
Zurich, Canton of Zurich, 8037
About this study
This study aims to develop and validate a tool for immediate nutrition assessment and to test its user feasibility in routine clinical practice for health promotion.
Read the detailed description
Small changes in diet have been shown to have an important impact on health and the risk of age-related chronic diseases, such as cardiovascular disease, diabetes, frailty and dementia. However, this knowledge has not yet been implemented into routine clinical practice, because practical tools that allow a comprehensive nutrition assessment in the clinical care setting are missing. In addition, doctors are generally not educated in giving nutritional advice to patients. In this pilot project, we aim to push forward and enable the potential of nutrition as a core primary prevention strategy for people at risk of developing chronic diseases. This will be achieved by using, as a stepping stone, the electronic 216-food-item food frequency questionnaire which was developed for the European DO-HEALTH study and was tested in over 2000 adults. The investigators want to extend this tool to not only capture the personal dietary intake, but also to produce an immediate report, comparing the personal diet to the Mediterranean and MIND diet patterns and providing a patient's intake of protein and other nutrients. The report will additionally indicate the patient's diet-related, personalized risks of cardio-vascular disease, diabetes, frailty and cognitive decline, and recommend dietary changes to reduce these risks.
- Conditions
- Diabetes, Hypertension, Frailty, Dementia, Cardiovascular Diseases
- Being tested
- eNutrition Optimizer
- Keywords
- Mediterranean Diet, MIND Diet, Healthy Aging
- Medical subject headings
- Diabetes Mellitus, Hypertension, Frailty, Dementia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eNutrition OptimizerDevice
The eNutrition optimizer is based on the electronic food frequency questionnaire (FFQ) used in the multicentre randomized controlled trail DO-HEALTH [56] developed by the CAM. The FFQ is split up in sections of 33 food groups and contains 216 items. It asks the user on the relative frequency of consumption of the different foods showing a picture of the food in the portion size of interest. Within the eNutrition Optimizer, the FFQ will be extended to create an output of the user's adherence to the Mediterranean diet, the MIND diet and the adherence with the current dietary recommendations for micro- and macronutrients provided by the Swiss Society for Nutrition and the DACH-references, compare it to the DO-HEALTH population and give recommendations on how to improve the score.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Group | Active comparator | After signing the informed consent, outpatients will be invited for a clinical baseline visit at the Center on Aging and Mobility (CAM), where they will complete the dietary assessment with the eNutrition optimizer at the CAM guided by the study physicians, who will also interpret the immediate results and recommendations produced by the tool to the study participant.
For validating the eNutrition-Optimizer tool, participants will be asked to report their dietary intake in the past 24h during a "24-h diet recall phone call" conducted by a trained interviewer on random days (weekday and weekend), so the participant cannot prepare or alter their habits. This 24h diet recall phone calls will be performed 4 times during the second half of the follow-up (month 4 to 6). In addition participants will complete the System Usability Scale at baseline and the subjective effectiveness questionnaire at month 6. Receives: Device: eNutrition Optimizer |
| Inpatient Group | Active comparator | After signing the informed consent, inpatients (Senior trauma center/heart surgery) will do the dietary assessment with the eNutrition optimizer with supervision of a trained study physician to assess user feasibility in the inpatient setting. In addition they will have a follow-up phone call at month 3 to 6 to assess the subjective effectiveness of the eNO. Receives: Device: eNutrition Optimizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception questionnaire using system usability scale
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Measured: Baseline
Subjective effectiveness questionnaire of eNutrition Optimizer
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Measured: month 3 to 6
Secondary outcomes (18)
24h diet recalls
Validation Study (outpatient group)
Measured: month 4 to 6
blood marker Non-HDL cholesterol (mmol/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker HDL cholesterol (mmol/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Triglycerides (mmol/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker HbA1C (%)
Validation Study (outpatient group)
Measured: 6 months
blood marker Fasting glucose (mmol/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Vitamin B12 (ng/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Folate (µg/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Iron (µmol/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Transferrin (µmol/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Soluble transferrin receptor (mg/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Ferritin (µg/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker high sensitive-CRP (mg/l)
Validation Study (outpatient group)
Measured: 6 months
blood marker Interleukin-6 (pg/ml)
Validation Study (outpatient group)
Measured: 6 months
Dietary patterns assessed with the eNutrition Optimizer (based on a food frequency questionnaire), MIND diet score ranging from 0 to 15 with 0=worst, 15=best ; Med Diet score ranging from 0 to 55 with 0=worst, 15=best
Change in diet (outpatient group)
Measured: 6 months
BMI
Change in diet (outpatient group) and safety (outpatient group)
Measured: 6 months
waist-to-hip ratio
Change in diet (outpatient group) and safety (outpatient group)
Measured: 6 months
systolic and diastolic blood pressure
Change in diet (outpatient group)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start11 Nov 2021
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Pilot study (exploratory case-crossover study) for user feasibility and validation of the eNutrition Optimizer
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heike Bischoff-Ferrari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heike Bischoff-Ferrari, University of Zurich
- Investigators
- Heike Bischoff-Ferrari, MD,DrPH, Principal investigator, Center on Aging and Monbility, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866264
- Sponsor's protocol ID
- 2019-02379
- Other IDs
- 2019
- Acronym
- eNO
- Status last verified
- Aug 2024
- First submitted
- 1 Apr 2021
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic-Nutrition-Optimizer for Personalized Prevention
- ClinicalTrials.gov ID
- NCT04866264
- Acronym / sponsor ID
- eNO / 2019-02379
- Conditions
- Diabetes, Hypertension, Frailty, Dementia, Cardiovascular Diseases
- Keywords
- Mediterranean Diet, MIND Diet, Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Heike Bischoff-FerrariUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 29 Apr 2021 (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 aims to develop and validate a tool for immediate nutrition assessment and to test its user feasibility in routine clinical practice for health promotion.
Detailed description
Small changes in diet have been shown to have an important impact on health and the risk of age-related chronic diseases, such as cardiovascular disease, diabetes, frailty and dementia. However, this knowledge has not yet been implemented into routine clinical practice, because practical tools that allow a comprehensive nutrition assessment in the clinical care setting are missing. In addition, doctors are generally not educated in giving nutritional advice to patients. In this pilot project, we aim to push forward and enable the potential of nutrition as a core primary prevention strategy for people at risk of developing chronic diseases. This will be achieved by using, as a stepping stone, the electronic 216-food-item food frequency questionnaire which was developed for the European DO-HEALTH study and was tested in over 2000 adults. The investigators want to extend this tool to not only capture the personal dietary intake, but also to produce an immediate report, comparing the personal diet to the Mediterranean and MIND diet patterns and providing a patient's intake of protein and other nutrients. The report will additionally indicate the patient's diet-related, personalized risks of cardio-vascular disease, diabetes, frailty and cognitive decline, and recommend dietary changes to reduce these risks.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study (exploratory case-crossover study) for user feasibility and validation of the eNutrition Optimizer
| Arm | Type | Receives |
|---|---|---|
| Outpatient Group | Active comparator | Device: eNutrition OptimizerAfter signing the informed consent, outpatients will be invited for a clinical baseline visit at the Center on Aging and Mobility (CAM), where they will complete the dietary assessment with the eNutrition optimizer at the CAM guided by the study physicians, who will also interpret the immediate results and recommendations produced by the tool to the study participant. For validating the eNutrition-Optimizer tool, participants will be asked to report their dietary intake in the past 24h during a "24-h diet recall phone call" conducted by a trained interviewer on random days (weekday and weekend), so the participant cannot prepare or alter their habits. This 24h diet recall phone calls will be performed 4 times during the second half of the follow-up (month 4 to 6). In addition participants will complete the System Usability Scale at baseline and the subjective effectiveness questionnaire at month 6. |
| Inpatient Group | Active comparator | Device: eNutrition OptimizerAfter signing the informed consent, inpatients (Senior trauma center/heart surgery) will do the dietary assessment with the eNutrition optimizer with supervision of a trained study physician to assess user feasibility in the inpatient setting. In addition they will have a follow-up phone call at month 3 to 6 to assess the subjective effectiveness of the eNO. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group)
- Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group)
- ≥50 years
Key exclusion criteria (10 listed)
- If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded
- People with an impaired short-term memory (MMSE <24)
- Patients following a specific diet recommended by a medical professional, due to diseases such as diabetes, chronic diseases of the gastrointestinal tract, severe kidney disease, or patients allergic to the main components of the Mediterranean diet/MINDdiet (olive oil, nuts)
- Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM
- BMI > 30 kg/m2
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 |
|---|---|---|
| eNutrition OptimizerThe eNutrition optimizer is based on the electronic food frequency questionnaire (FFQ) used in the multicentre randomized controlled trail DO-HEALTH [56] developed by the CAM. The FFQ is split up in sections of 33 food groups and contains 216 items. It asks the user on the relative frequency of consumption of the different foods showing a picture of the food in the portion size of interest. Within the eNutrition Optimizer, the FFQ will be extended to create an output of the user's adherence to the Mediterranean diet, the MIND diet and the adherence with the current dietary recommendations for micro- and macronutrients provided by the Swiss Society for Nutrition and the DACH-references, compare it to the DO-HEALTH population and give recommendations on how to improve the score. | Device | Inpatient Group, Outpatient Group |
Primary outcome
Perception questionnaire using system usability scale
Time frame: Baseline
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
Subjective effectiveness questionnaire of eNutrition Optimizer
Time frame: month 3 to 6
Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"
18 secondary outcomes
24h diet recalls
Time frame: month 4 to 6
blood marker Non-HDL cholesterol (mmol/l)
Time frame: 6 months
blood marker HDL cholesterol (mmol/l)
Time frame: 6 months
blood marker Triglycerides (mmol/l)
Time frame: 6 months
blood marker HbA1C (%)
Time frame: 6 months
blood marker Fasting glucose (mmol/l)
Time frame: 6 months
blood marker Vitamin B12 (ng/l)
Time frame: 6 months
blood marker Folate (µg/l)
Time frame: 6 months
blood marker Iron (µmol/l)
Time frame: 6 months
blood marker Transferrin (µmol/l)
Time frame: 6 months
blood marker Soluble transferrin receptor (mg/l)
Time frame: 6 months
blood marker Ferritin (µg/l)
Time frame: 6 months
blood marker high sensitive-CRP (mg/l)
Time frame: 6 months
blood marker Interleukin-6 (pg/ml)
Time frame: 6 months
Dietary patterns assessed with the eNutrition Optimizer (based on a food frequency questionnaire), MIND diet score ranging from 0 to 15 with 0=worst, 15=best ; Med Diet score ranging from 0 to 55 with 0=worst, 15=best
Time frame: 6 months
BMI
Time frame: 6 months
waist-to-hip ratio
Time frame: 6 months
systolic and diastolic blood pressure
Time frame: 6 months
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 7 Aug 2024.
- 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.
Heike Bischoff-Ferrari, MD,DrPH principal investigator
Center on Aging and Monbility, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eNutrition Optimizer in people with Diabetes and Hypertension, run by Heike Bischoff-Ferrari at 1 site in Switzerland.
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 3 inclusion and 10 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 7 Aug 2024. 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 Switzerland. 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?
Perception questionnaire using system usability scale (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.