Clinical trial NCT04866264: Electronic-Nutrition-Optimizer for Personalized Prevention
Official title: Electronic-Nutrition-Optimizer for Personalized Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Frailty
Dementia
Cardiovascular Diseases
Keywords: Mediterranean Diet
MIND Diet
Healthy Aging
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot study (exploratory case-crossover study) for user feasibility and validation of the eNutrition Optimizer
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group)
2. Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group)
3. ≥50 years

Exclusion Criteria:

1. If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded
2. People with an impaired short-term memory (MMSE \<24)
3. 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)
4. Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM
5. BMI \> 30 kg/m2
6. Individuals per se not willing to change diet
7. Instable clinical conditions (e.g. acute infection) at enrolment
8. Patients with active cancer (except non-melanoma skin cancer) or current cancer treatment or any other advanced severe disease
9. Living in a nursing home and/or receiving prepared meals (i.e. usually not eating home cooked meals)
10. Inability to read and or speak German necessary to understand the instructions

Primary outcomes:
measure: Perception questionnaire using system usability scale
timeFrame: Baseline
measure: Subjective effectiveness questionnaire of eNutrition Optimizer
timeFrame: month 3 to 6
Secondary outcomes:
measure: 24h diet recalls
timeFrame: month 4 to 6
measure: blood marker Non-HDL cholesterol (mmol/l)
timeFrame: 6 months
measure: blood marker HDL cholesterol (mmol/l)
timeFrame: 6 months
measure: blood marker Triglycerides (mmol/l)
timeFrame: 6 months
measure: blood marker HbA1C (%)
timeFrame: 6 months
measure: blood marker Fasting glucose (mmol/l)
timeFrame: 6 months
measure: blood marker Vitamin B12 (ng/l)
timeFrame: 6 months
measure: blood marker Folate (µg/l)
timeFrame: 6 months
measure: blood marker Iron (µmol/l)
timeFrame: 6 months
measure: blood marker Transferrin (µmol/l)
timeFrame: 6 months
measure: blood marker Soluble transferrin receptor (mg/l)
timeFrame: 6 months
measure: blood marker Ferritin (µg/l)
timeFrame: 6 months
measure: blood marker high sensitive-CRP (mg/l)
timeFrame: 6 months
measure: blood marker Interleukin-6 (pg/ml)
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: waist-to-hip ratio
timeFrame: 6 months
measure: systolic and diastolic blood pressure
timeFrame: 6 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Centre on Aging and Mobility, University of Zurich
state: ZH
Study officials:
affiliation: Center on Aging and Monbility, University of Zurich
name: Heike Bischoff-Ferrari, MD,DrPH
role: PRINCIPAL_INVESTIGATOR
References: