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Clinical Trial Summary

In this explorative study, the feasibility of therapeutic fasting to reduce limitations in physical well-being and quality of life of patients undergoing endocrine therapy with aromatase inhibitors will be investigated. In addition, the application of the StudyU app, which is currently under development, will be monitored and the app adapted if necessary. In addition, in preparation for a larger multicenter main study, it will be examined whether the muscle and joint complaints frequently experienced by patients undergoing endocrine therapy with aromatase inhibitors (AI) can be alleviated by a 7-day guided therapeutic fasting intervention (prolonged fasting / PF) can be improved.


Clinical Trial Description

After baseline (t0), all patients will receive the following intervention: 7 days of online supervised prolonged therapeutic fasting (max. 350 kcal/d). Following the study intervention, at t1, patients will be offered a for a potential effect as sustainable as possible in addition to a dietary change. According to the following criteria: - As plant-based as possible - Rich in nutritive prebiotics - In addition, this group should include intermittent fasting/time restricted eating (16/8h) into their dietary habits (at least 6d/week). All patients will be interviewed on a regular basis and anthropometric data will be collected accordingly at following time points: - t1 (at the end of the fasting intervention). - t2 (3 months after t0) ;


Study Design


NCT number NCT06172088
Study type Interventional
Source University Hospital Tuebingen
Contact Claudia Loeffler, Dr
Phone +4993120
Email loeffler_C@ukw.de
Status Recruiting
Phase N/A
Start date December 15, 2023
Completion date September 30, 2025