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NCT04717076: PrevA

PrevA Study - Evaluation of an App-based Nutritional Concept

Completed NA Last updated 3 March 2022
What this trial tests

NA trial testing App-based nutritional concept and fitness tracking in Reduction of Cardiovascular Risk Factors in 80 participants. Completed in 12 October 2021.

Timeline
12 April 2021
Primary endpoint
12 August 2021
12 October 2021

Quick facts

Lead sponsorUniversity of Jena
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment80
Start date12 April 2021
Primary completion12 August 2021
Estimated completion12 October 2021
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University of Jena

Who can join

Adults 20 to 69, any sex, with Reduction of Cardiovascular Risk Factors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other University of Jena trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04717076.

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