PrevA Study - Evaluation of an App-based Nutritional Concept to Lower Cardiovascular Risk Factors (Focus: Weight Reduction)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Body weight
Study Overview
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. The plans are personalized according to participants age, gender, and level of physical activity. The PrevA study consists of four periods differing in the energy intake specified by the menu plans.
The study is carried out in a 4-armed parallel design. In group 1, the participants receive the individualized daily plans via the app coupled with the smartwatch to record participants physical activity and heart rate. Groups 2 and 3 receive a printed version of the daily plans with or without personal nutritional advice. The fourth group serves as a control group, which receives general nutritional recommendations but no daily menu plans. During this time, blood samples and urine are collected every four weeks to analyze the study parameters.
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 comparatively small. To address this weak point, we developed a personalized nutritional concept to implement a heart-healthy diet. In cooperation with the Preventicus GmbH, Jena, the concept was integrated in an App-based tool. In addition, the app relates to a smartwatch to encourage and track physical activity. The PrevA study will be conducted to evaluate the overall concept.
The nutritional concept based on nutrient-optimized daily menu plans for each study day. The plans are personalized according to participants age, gender, and level of physical activity.
The study is carried out in a 4-armed parallel design. In group 1, the participants receive the individualized daily plans via the app coupled with the smartwatch to record participants physical activity and heart rate. Groups 2 and 3 receive a printed version of the daily plans with or without personal nutritional advice. The fourth group serves as a control group, which receives general nutritional recommendations but no daily menu plans.
In groups 1 to 3, the daily plans are issued in 4 energy levels. At the beginning, the test subjects receive daily plans according to the recommendations for energy intake of the German Nutrition Society (DGE), adapted to their age, gender, and activity level (level 1). After four study weeks, the energy content of the plans is reduced to 85% of the energy intake recommended by the DGE (level 2) and after further four weeks of the PrevA study the energy level is reduced to 70% of the energy intake recommended by the DGE (level 3). Level 4 serves as a stabilization phase and provides the energy content of level 1. The study period extends over a total of 16 study weeks. During this time, blood samples and urine are collected every four weeks to analyze the study parameters. In addition, anthropometric data, data on personal health status and cardiovascular risk profile are assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Body weight
Time Frame: change from baseline after 4, 8, 12, 16 weeks
Body weight (kg)
Secondary Outcomes
- Body fat(change from baseline after 4, 8, 12, 16 weeks)
- Diastolic blood pressure(change from baseline after 4, 8, 12, 16 weeks)
- Basal metabolic rate(change from baseline after 4, 8, 12, 16 weeks)
- Total cholesterol (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Systolic blood pressure(change from baseline after 4, 8, 12, 16 weeks)
- HDL cholesterol (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Insulin (fasting) (serum)(change from baseline after 4, 8, 12, 16 weeks)
- LDL cholesterol (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Triacylglycerides (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Glucose (fasting) (serum)(change from baseline after 4, 8, 12, 16 weeks)
- HbA1c (serum)(change from baseline after 4, 8, 12, 16 weeks)
- Fibrinogen (serum)(change from baseline after 4, 8, 12, 16 weeks)
- alpha prothrombin time (serum)(change from baseline after 4, 8, 12, 16 weeks)
- Triiodothyronine (plasma)(change from baseline after 16 weeks)
- Thyroid-stimulating hormone (plasma)(change from baseline after 16 weeks)
- High sensitive c-reactive protein (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Homocysteine (serum)(change from baseline after 4, 8, 12, 16 weeks)
- Alkaline phosphatase (serum)(change from baseline after 16 weeks)
- Gamma-glutamyltransferase (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Lactate dehydrogenase (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Vitamin B1 (serum)(change from baseline after 16 weeks)
- Vitamin B2 (serum)(change from baseline after 16 weeks)
- Thyroxine (plasma)(change from baseline after 16 weeks)
- Parathyroid hormone (plasma)(change from baseline after 16 weeks)
- Osteocalcin (serum)(change from baseline after 16 weeks)
- Vitamin A (serum)(change from baseline after 16 weeks)
- Vitamin B6 (serum)(change from baseline after 16 weeks)
- Folic acid (plasma)(change from baseline after 16 weeks)
- Alanine aminotransferase (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Aspartate transaminase (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Cholinesterase (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Vitamin E (serum)(change from baseline after 16 weeks)
- Calcium (plasma)(change from baseline after 16 weeks)
- Uric acid (plasma)(change from baseline after 16 weeks)
- Fatty acid distribution in plasma lipids (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Vitamin D (plasma)(change from baseline after 16 weeks)
- Fatty acid distribution in erythrocyte lipids (erythrocytes)(change from baseline after 4, 8, 12, 16 weeks)
- Vitamin B12 (plasma)(change from baseline after 16 weeks)
- Holo-transcobalamin (plasma)(change from baseline after 16 weeks)
- Vitamin C (plasma)(change from baseline after 16 weeks)
- Potassium (plasma)(change from baseline after 16 weeks)
- Iron (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Vitamin H (serum)(change from baseline after 16 weeks)
- Ferritin (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Transferrin (plasma)(change from baseline after 4, 8, 12, 16 weeks)
- Iodine (serum)(change from baseline after 16 weeks)
- Selenium (serum)(change from baseline after 16 weeks)
- Zinc (serum)(change from baseline after 16 weeks)
Investigators
Christine Dawczynski,PhD
PhD, Head of Junior Research Group Nutritional Concepts, University of Jena
University of Jena