PrevA Study - Evaluation of an App-based Nutritional Concept

Reduction of Cardiovascular Risk Factors Clinical Trial

— PrevA  

Official title:

PrevA Study - Evaluation of an App-based Nutritional Concept to Lower Cardiovascular Risk Factors (Focus: Weight Reduction)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04717076
• Other study ID #: H11_21
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: October 12, 2021

Study information

• Verified date: January 2021
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Reduction of Cardiovascular Risk Factors

Intervention

Behavioral:
• App-based nutritional concept and fitness tracking
The App-based nutritional concept based on menu plan, which are personalized according to participants age, gender, physical activity. The App is coupled with a Smartwatch to encourage and track physical activity over the study period.
• Nutritional concept with individual nutritional counselling
Nutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study)
• Nutritional concept without individual nutritional counselling
Nutritional concept based on personalized menu plans

Locations

Country	Name	City	State
Germany	Friedrich-Schiller University	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Creatinine (24 h urine)	Creatinine (mmol/l)	change from baseline after 16 weeks
Other	Albumine (24 h urine)	Albumine (mg/l)	change from baseline after 16 weeks
Other	Selenium (24 h urine)	Selenium (µmol/24 h)	change from baseline after 16 weeks
Other	Zinc (24 h urine)	Zinc (µmol/24 h)	change from baseline after 16 weeks
Primary	Body weight	Body weight (kg)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Body fat	Body fat (%)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Systolic blood pressure	systolic pressure (mm Hg)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Diastolic blood pressure	diastolic blood pressure (mm Hg)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Basal metabolic rate	Basal metabolic rate (kcal per day) - measurement: indirect calorimetry	change from baseline after 4, 8, 12, 16 weeks
Secondary	Total cholesterol (plasma)	Total cholesterol (mmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	LDL cholesterol (plasma)	LDL cholesterol (mmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	HDL cholesterol (plasma)	HDL cholesterol (mmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Triacylglycerides (plasma)	Triacylglycerides (mmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Glucose (fasting) (serum)	Glucose (mmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Insulin (fasting) (serum)	Insulin (mU/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	HbA1c (serum)	HbA1c (%)	change from baseline after 4, 8, 12, 16 weeks
Secondary	alpha prothrombin time (serum)	alpha prothrombin time (s)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Fibrinogen (serum)	Fibrinogen (g/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	High sensitive c-reactive protein (plasma)	High sensitive c-reactive protein (mg/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Homocysteine (serum)	Homocysteine (µmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Triiodothyronine (plasma)	Triiodothyronine fT3 (pmol/l)	change from baseline after 16 weeks
Secondary	Thyroxine (plasma)	Thyroxine fT4 (pmol/l)	change from baseline after 16 weeks
Secondary	Thyroid-stimulating hormone (plasma)	Thyroid-stimulating hormone (mU/l)	change from baseline after 16 weeks
Secondary	Parathyroid hormone (plasma)	Parathyroid hormone (ng/l)	change from baseline after 16 weeks
Secondary	Alkaline phosphatase (serum)	Alkaline phosphatase (µg/l)	change from baseline after 16 weeks
Secondary	Osteocalcin (serum)	Osteocalcin (ng/ml)	change from baseline after 16 weeks
Secondary	Uric acid (plasma)	Uric acid (µmol/l)	change from baseline after 16 weeks
Secondary	Alanine aminotransferase (plasma)	Alanine aminotransferase (µmol/l*s)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Aspartate transaminase (plasma)	Aspartate transaminase (µmol/l*s)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Cholinesterase (plasma)	Cholinesterase (µmol/l*s)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Gamma-glutamyltransferase (plasma)	Gamma-glutamyltransferase (µmol/l*s)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Lactate dehydrogenase (plasma)	Lactate dehydrogenase (µmol/l*s)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Fatty acid distribution in plasma lipids (plasma)	Fatty acid distribution in plasma lipids (% fatty acid methyl esters)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Fatty acid distribution in erythrocyte lipids (erythrocytes)	Fatty acid distribution in erythrocyte lipids (% fatty acid methyl esters)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Vitamin A (serum)	Vitamin A (mmol/l)	change from baseline after 16 weeks
Secondary	Vitamin D (plasma)	Vitamin D (nmol/l)	change from baseline after 16 weeks
Secondary	Vitamin E (serum)	Vitamin E (µmol/l)	change from baseline after 16 weeks
Secondary	Vitamin B1 (serum)	Vitamin B1 (nmol/l)	change from baseline after 16 weeks
Secondary	Vitamin B2 (serum)	Vitamin B2 (nmol/l)	change from baseline after 16 weeks
Secondary	Vitamin B6 (serum)	Vitamin B6 (nmol/l)	change from baseline after 16 weeks
Secondary	Vitamin B12 (plasma)	Vitamin B12 (pmol/l)	change from baseline after 16 weeks
Secondary	Holo-transcobalamin (plasma)	Holo-transcobalamin (pmol/l)	change from baseline after 16 weeks
Secondary	Folic acid (plasma)	Folic acid (µg/l)	change from baseline after 16 weeks
Secondary	Vitamin H (serum)	Vitamin H (ng/l)	change from baseline after 16 weeks
Secondary	Vitamin C (plasma)	Vitamin C (mg/l)	change from baseline after 16 weeks
Secondary	Calcium (plasma)	Calcium (mmol/l)	change from baseline after 16 weeks
Secondary	Potassium (plasma)	Potassium (mmol/l)	change from baseline after 16 weeks
Secondary	Iron (plasma)	Iron (µmol/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Ferritin (plasma)	Ferritin (µg/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Transferrin (plasma)	Transferrin (g/l)	change from baseline after 4, 8, 12, 16 weeks
Secondary	Iodine (serum)	Iodine (µmol/l)	change from baseline after 16 weeks
Secondary	Selenium (serum)	Selenium (µmol/l)	change from baseline after 16 weeks
Secondary	Zinc (serum)	Zinc (µmol/l)	change from baseline after 16 weeks