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Completed

NCT Number: NCT04866264

Electronic-Nutrition-Optimizer for Personalized Prevention

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

eNutrition Optimizer

Device

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.

Primary outcomes

  1. 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"

  2. 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"

Secondary outcomes

  1. 24h diet recalls

    Time frame: month 4 to 6

    Validation Study (outpatient group)

  2. blood marker Non-HDL cholesterol (mmol/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  3. blood marker HDL cholesterol (mmol/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  4. blood marker Triglycerides (mmol/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  5. blood marker HbA1C (%)

    Time frame: 6 months

    Validation Study (outpatient group)

  6. blood marker Fasting glucose (mmol/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  7. blood marker Vitamin B12 (ng/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  8. blood marker Folate (µg/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  9. blood marker Iron (µmol/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  10. blood marker Transferrin (µmol/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  11. blood marker Soluble transferrin receptor (mg/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  12. blood marker Ferritin (µg/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  13. blood marker high sensitive-CRP (mg/l)

    Time frame: 6 months

    Validation Study (outpatient group)

  14. blood marker Interleukin-6 (pg/ml)

    Time frame: 6 months

    Validation Study (outpatient group)

  15. 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

    Change in diet (outpatient group)

  16. BMI

    Time frame: 6 months

    Change in diet (outpatient group) and safety (outpatient group)

  17. waist-to-hip ratio

    Time frame: 6 months

    Change in diet (outpatient group) and safety (outpatient group)

  18. systolic and diastolic blood pressure

    Time frame: 6 months

    Change in diet (outpatient group)

Sponsors and collaborators

Lead sponsor

Heike Bischoff-Ferrari

Other

Registry information

Acronym: eNO

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2021
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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