Electronic-Nutrition-Optimizer for Personalized Prevention

Hypertension Clinical Trial

— eNO  

Official title:

Electronic-Nutrition-Optimizer for Personalized Prevention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04866264
• Other study ID #: 2019-02379
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: University of Zurich
• Contact: Heike Bischoff-Ferrari, MD,DrPH
• Phone: +41442552527
• Email: heike.bischoff[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Dementia
• Diabetes
• Frailty
• Hypertension

Intervention

Device:
• eNutrition Optimizer
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.

Locations

Country	Name	City	State
Switzerland	Centre on Aging and Mobility, University of Zurich and City Hospital Waid and Triemli	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Heike Bischoff-Ferrari

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perception questionnaire using system usability scale	Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"	Baseline
Primary	Subjective effectiveness questionnaire of eNutrition Optimizer	Feasibility Study (in- and outpatient group) Scale from 1 to 5, indicating 1 "not true", 5 "very true"	month 3 to 6
Secondary	24h diet recalls	Validation Study (outpatient group)	month 4 to 6
Secondary	blood marker Non-HDL cholesterol (mmol/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker HDL cholesterol (mmol/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Triglycerides (mmol/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker HbA1C (%)	Validation Study (outpatient group)	6 months
Secondary	blood marker Fasting glucose (mmol/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Vitamin B12 (ng/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Folate (µg/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Iron (µmol/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Transferrin (µmol/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Soluble transferrin receptor (mg/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Ferritin (µg/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker high sensitive-CRP (mg/l)	Validation Study (outpatient group)	6 months
Secondary	blood marker Interleukin-6 (pg/ml)	Validation Study (outpatient group)	6 months
Secondary	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)	6 months
Secondary	BMI	Change in diet (outpatient group) and safety (outpatient group)	6 months
Secondary	waist-to-hip ratio	Change in diet (outpatient group) and safety (outpatient group)	6 months
Secondary	systolic and diastolic blood pressure	Change in diet (outpatient group)	6 months