Feasibility of Lifestyle Intervention in BRCA1/2 Mutation Carriers
NCT ID: NCT02087592
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2014-02-28
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Usual standard of care
No interventions assigned to this group
Intervention
Usual standard of care plus structured physical exercise training plus mediterranean-style diet
Structured exercise training plus mediterranean diet
Interventions
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Structured exercise training plus mediterranean diet
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* life expectancy \<3 years
* clinically limiting cardiovascular or respiratory disease
* significant orthopedic disability which prevents from participating in the exercise training
* severe concomitant disease which prevents from participating in the group interventions
* Karnofsky index \<60
* VO2max \>150%
* Maximal exercise capacity \< 50 W
* food allergies which prevent from mediterranean diet
* vegan diet
* body mass index \<15 kg/m2
* pregnancy
* insufficient knowledge of German language
* insufficient compliance
* active participation in other interventional trials
* no informed consent
18 Years
69 Years
FEMALE
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Marion Kiechle, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Technical University of Munich
Martin Halle, Prof. Dr.
Role: STUDY_DIRECTOR
Technical University of Munich
Stephan C Bischoff, Prof. Dr.
Role: STUDY_DIRECTOR
Universitaet Hohenheim, Stuttgart
Wolf-Dieter Gerber, Prof. Dr.
Role: STUDY_DIRECTOR
Universitaetsklinikum Schleswig-Holstein, Campus Kiel
Markus Loeffler, Prof. Dr.
Role: STUDY_DIRECTOR
University of Leipzig
Christoph Engel, Dr.
Role: STUDY_DIRECTOR
University of Leipzig
Rita K Schmutzler, Prof. Dr.
Role: STUDY_DIRECTOR
University of Cologne
Alfons Meindl, Prof. Dr.
Role: STUDY_DIRECTOR
Technical University of Munich
Locations
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University of Cologne
Cologne, , Germany
University of Schleswig-Holstein Campus Kiel
Kiel, , Germany
Technische Universitaet Muenchen
Munich, , Germany
Countries
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References
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Seethaler B, Neyrinck AM, Basrai M, Kiechle M, Delzenne NM, Bischoff SC. Elucidating the effect of the Mediterranean diet on fecal bile acids and their mediating role on biomarkers of intestinal barrier function: An exploratory analysis of a randomized controlled trial. Life Sci. 2025 Oct 15;379:123855. doi: 10.1016/j.lfs.2025.123855. Epub 2025 Jul 26.
Seethaler B, Lehnert K, Yahiaoui-Doktor M, Basrai M, Vetter W, Kiechle M, Bischoff SC. Omega-3 polyunsaturated fatty acids improve intestinal barrier integrity-albeit to a lesser degree than short-chain fatty acids: an exploratory analysis of the randomized controlled LIBRE trial. Eur J Nutr. 2023 Oct;62(7):2779-2791. doi: 10.1007/s00394-023-03172-2. Epub 2023 Jun 15.
Seethaler B, Nguyen NK, Basrai M, Kiechle M, Walter J, Delzenne NM, Bischoff SC. Short-chain fatty acids are key mediators of the favorable effects of the Mediterranean diet on intestinal barrier integrity: data from the randomized controlled LIBRE trial. Am J Clin Nutr. 2022 Oct 6;116(4):928-942. doi: 10.1093/ajcn/nqac175.
Berling-Ernst A, Yahiaoui-Doktor M, Kiechle M, Engel C, Lammert J, Grill S, Dukatz R, Rhiem K, Baumann FT, Bischoff SC, Erickson N, Schmidt T, Niederberger U, Siniatchkin M, Halle M. Predictors of cardiopulmonary fitness in cancer-affected and -unaffected women with a pathogenic germline variant in the genes BRCA1/2 (LIBRE-1). Sci Rep. 2022 Feb 21;12(1):2907. doi: 10.1038/s41598-022-06913-1.
Seethaler B, Basrai M, Vetter W, Lehnert K, Engel C, Siniatchkin M, Halle M, Kiechle M, Bischoff SC. Fatty acid profiles in erythrocyte membranes following the Mediterranean diet - data from a multicenter lifestyle intervention study in women with hereditary breast cancer (LIBRE). Clin Nutr. 2020 Aug;39(8):2389-2398. doi: 10.1016/j.clnu.2019.10.033. Epub 2019 Nov 2.
Kiechle M, Dukatz R, Yahiaoui-Doktor M, Berling A, Basrai M, Staiger V, Niederberger U, Marter N, Lammert J, Grill S, Pfeifer K, Rhiem K, Schmutzler RK, Laudes M, Siniatchkin M, Halle M, Bischoff SC, Engel C. Feasibility of structured endurance training and Mediterranean diet in BRCA1 and BRCA2 mutation carriers - an interventional randomized controlled multicenter trial (LIBRE-1). BMC Cancer. 2017 Nov 10;17(1):752. doi: 10.1186/s12885-017-3732-4.
Hebestreit K, Yahiaoui-Doktor M, Engel C, Vetter W, Siniatchkin M, Erickson N, Halle M, Kiechle M, Bischoff SC. Validation of the German version of the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. BMC Cancer. 2017 May 18;17(1):341. doi: 10.1186/s12885-017-3337-y.
Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff S, Dukatz R, Gerber WD, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Marter N, Enders U, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Lifestyle intervention in BRCA1/2 mutation carriers: study protocol for a prospective, randomized, controlled clinical feasibility trial (LIBRE-1 study). Pilot Feasibility Stud. 2016 Dec 19;2:74. doi: 10.1186/s40814-016-0114-7. eCollection 2016.
Related Links
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Related Info
Other Identifiers
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LIBRE-F-110013
Identifier Type: -
Identifier Source: org_study_id
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