Clinical trial NCT04717076: PrevA Study - Evaluation of an App-based Nutritional Concept
Official title: PrevA Study - Evaluation of an App-based Nutritional Concept to Lower Cardiovascular Risk Factors (Focus: Weight Reduction)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Cardiovascular Risk Factors
Keywords: personalized nutritional concept, weight reduction, mHealth
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body weight
timeFrame: change from baseline after 4, 8, 12, 16 weeks
Secondary outcomes:
measure: Body fat
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Systolic blood pressure
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Diastolic blood pressure
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Basal metabolic rate
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Total cholesterol (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: LDL cholesterol (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: HDL cholesterol (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Triacylglycerides (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Glucose (fasting) (serum)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Insulin (fasting) (serum)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: HbA1c (serum)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: alpha prothrombin time (serum)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Fibrinogen (serum)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: High sensitive c-reactive protein (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Homocysteine (serum)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Triiodothyronine (plasma)
timeFrame: change from baseline after 16 weeks
measure: Thyroxine (plasma)
timeFrame: change from baseline after 16 weeks
measure: Thyroid-stimulating hormone (plasma)
timeFrame: change from baseline after 16 weeks
measure: Parathyroid hormone (plasma)
timeFrame: change from baseline after 16 weeks
measure: Alkaline phosphatase (serum)
timeFrame: change from baseline after 16 weeks
measure: Osteocalcin (serum)
timeFrame: change from baseline after 16 weeks
measure: Uric acid (plasma)
timeFrame: change from baseline after 16 weeks
measure: Alanine aminotransferase (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Aspartate transaminase (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Cholinesterase (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Gamma-glutamyltransferase (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Lactate dehydrogenase (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Fatty acid distribution in plasma lipids (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Fatty acid distribution in erythrocyte lipids (erythrocytes)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Vitamin A (serum)
timeFrame: change from baseline after 16 weeks
measure: Vitamin D (plasma)
timeFrame: change from baseline after 16 weeks
measure: Vitamin E (serum)
timeFrame: change from baseline after 16 weeks
measure: Vitamin B1 (serum)
timeFrame: change from baseline after 16 weeks
measure: Vitamin B2 (serum)
timeFrame: change from baseline after 16 weeks
measure: Vitamin B6 (serum)
timeFrame: change from baseline after 16 weeks
measure: Vitamin B12 (plasma)
timeFrame: change from baseline after 16 weeks
measure: Holo-transcobalamin (plasma)
timeFrame: change from baseline after 16 weeks
measure: Folic acid (plasma)
timeFrame: change from baseline after 16 weeks
measure: Vitamin H (serum)
timeFrame: change from baseline after 16 weeks
measure: Vitamin C (plasma)
timeFrame: change from baseline after 16 weeks
measure: Calcium (plasma)
timeFrame: change from baseline after 16 weeks
measure: Potassium (plasma)
timeFrame: change from baseline after 16 weeks
measure: Iron (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Ferritin (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Transferrin (plasma)
timeFrame: change from baseline after 4, 8, 12, 16 weeks
measure: Iodine (serum)
timeFrame: change from baseline after 16 weeks
measure: Selenium (serum)
timeFrame: change from baseline after 16 weeks
measure: Zinc (serum)
timeFrame: change from baseline after 16 weeks
Other outcomes:
measure: Creatinine (24 h urine)
timeFrame: change from baseline after 16 weeks
measure: Albumine (24 h urine)
timeFrame: change from baseline after 16 weeks
measure: Selenium (24 h urine)
timeFrame: change from baseline after 16 weeks
measure: Zinc (24 h urine)
timeFrame: change from baseline after 16 weeks
Locations:
city: Jena
country: Germany
facility: Friedrich-Schiller University
state: Thuringia
Study officials:
affiliation: Friedrich-Schiller-University
name: Christine Dawczynski, PhD
role: PRINCIPAL_INVESTIGATOR
References: