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NCT04717076: PrevA
PrevA Study - Evaluation of an App-based Nutritional Concept
NA trial testing App-based nutritional concept and fitness tracking in Reduction of Cardiovascular Risk Factors in 80 participants. Completed in 12 October 2021.
12 August 2021
Quick facts
| Lead sponsor | University of Jena |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 12 April 2021 |
| Primary completion | 12 August 2021 |
| Estimated completion | 12 October 2021 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- App-based nutritional concept and fitness tracking
- Nutritional concept with individual nutritional counselling
- Nutritional concept without individual nutritional counselling
Conditions studied
- Reduction of Cardiovascular Risk Factors — all drugs for Reduction of Cardiovascular Risk Factors →
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.
Verify or expand the search:
- PubMed search for NCT04717076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04717076 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Jena
- Last refreshed: 3 March 2022
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing