Status:
COMPLETED
PrevA Study - Evaluation of an App-based Nutritional Concept
Lead Sponsor:
University of Jena
Conditions:
Reduction of Cardiovascular Risk Factors
Eligibility:
All Genders
20-69 years
Phase:
NA
Brief Summary
The PrevA study is designed to evaluate our developed nutritional concept to implement a heart healthy diet. The nutritional concept based on nutrient-optimized daily menu plans for each study day. Th...
Detailed Description
Smartphone-based communication technologies are developing rapidly, and the number of so-called mobile health applications is rising. The number of validated and scientifically tested offers is compar...
Eligibility Criteria
Inclusion
- Voluntary participation with documented informed consent
- Willingness and ability to adhere to the study protocol
- Males / female) aged ≥ 20 years and ≤ 51 years
- BMI: ≥ 25 ≤ 35 kg / m2 (obesity grade 1)
- Owning a smartphone (android)
- no or moderate alcohol consumption (≤ 2 glasses / week)
- non-smoker (if possible)
Exclusion
- Comorbidities:
- Hypercholesterolemia (genetic defect / familial predisposition)
- Diabetes mellitus type 1 or 2
- Thyroid dysfunction (hyper- or hypothyroidism)
- Food intolerance / allergies to ingredients in the study foods
- Medications: lipid-lowering drugs, glucocorticoids
- Dietary supplements: especially n-3 fatty acids, vitamin E.
- Extremely high physical activity (daily)
- Alcohol abuse (daily)
- (smoker) \[if there are not enough test persons available, \> 7 smokers should be included so that a statistical analysis is possible\]
- Uncontrolled organic diseases
- Alcohol, drug or drug abuse
- Participation in other clinical observational studies during or 4 weeks. before starting this study
- Serious behavioral problems, emotional problems or psychiatric problems which the investigator believes would lead to a lack of compliance
- Pregnancy, breastfeeding and unsafe contraception
- Other reasons that are considered important by the investigator
Key Trial Info
Start Date :
April 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04717076
Start Date
April 12 2021
End Date
October 12 2021
Last Update
March 3 2022
Active Locations (1)
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1
Friedrich-Schiller University
Jena, Thuringia, Germany, 07743