Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Hohenheim | OTHER |
| University Hospital Schleswig-Holstein | OTHER |
| University of Leipzig | OTHER |
| University of Cologne |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.
BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Study participants are instructed regarding a healthy diet according to the recommendations of the German Nutrition Society (DGE) and are informed about positive effects of physical activity on incidence and prognosis of breast cancer | |
| Intervention | Experimental | Structured exercise training plus mediterranean diet: Study participants receive a lifestyle intervention of 12 months duration (3 months intensive intervention plus 9 months maintenance using monthly contacts and meetings). The intervention comprises a structured intensified training based on the results of physical performance diagnostics and a nutrition program based on a mediterranean diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structured exercise training plus mediterranean diet | Behavioral | Structured exercise training plus mediterranean diet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mediterranean Diet Adherence Screener (MEDAS) Score (Questionnaire) | Adherence to mediterranean diet | 12 months |
| body mass index (BMI) | Body weight (in kilograms) divided by body height (in meters) squared. | 12 months |
| ventilatory threshold 1 (VT1) in spiroergometry | ventilatory threshold VT1 in spiroergometry | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| stress coping capacity, as measured by the Trier Inventory for Chronic Stress (TICS) questionnaire | (TICS) questionnaire | 3, 12, 24, 36 months |
| grade of optimism, as measured by the Life Orientation Test (LOT) questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion Kiechle, Prof. Dr. | Contact | +49 89 4140 2420 | marion.kiechle@tum.de | |
| Daniela Schemmer | Contact | +49 89 4140 2433 | Daniela.Schemmer@mri.tum.de |
| Name | Affiliation | Role |
|---|---|---|
| Marion Kiechle, Prof. Dr. | Technical University of Munich | Study Director |
| Martin Halle, Prof. Dr. | Technical University of Munich | Study Director |
| Stephan C Bischoff, Prof. Dr. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humboldt Universität zu Berlin | Recruiting | Berlin | Germany | |||
| Uniklinikum Köln |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36055959 | Derived | 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. | |
| 27473440 |
Not provided
Not provided
Not provided
| OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Life Orientation Test (LOT)
| 3, 12, 24, 36 months |
| attitudes and beliefs regarding physical training and healthy diet, as measured by the "Bewertung körperlicher Aktivität und Ernährung" (BKAE) questionnaire | (BKAE) questionnaire | 3, 12, 24, 36 months |
| quality of life, as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) | (EORTC QLQ-C30) | 3, 12, 24, 36 months |
| maximum oxygen consumption (VO2max), as measured by spiroergometry | spiroergometry | 3, 12 months |
| physical activity, as measured by the International Physical Activity Questionnaire (IPAQ) | Physical Activity | 3, 12, 24, 36 months |
| incidence of breast cancer | During study | 12, 24, 36 months |
| Mediterranean Diet Adherence Screener (MEDAS) Score | (MEDAS) Score | 3, 6, 9, 12, 24, 36 months |
| body mass index (BMI) | (BMI) | 3, 12, 24, 36 months |
| change of maximum oxygen consumption (VO2max) at ventilation threshold 1 (VT1), as measured by spiroergometry | spiroergometry | 3, 12 months |
| mortality rate | During study | 12, 24, 36 months |
| satisfaction (questionnaire) | satisfaction (questionnaire) | 3, 12, 24, 36 months |
| tobacco consumption | survey | 12, 24, 36 months |
| alcohol consumption | survey | 12, 24, 36 months |
| dietary habits and calory intake, as measured by the European Prospective Investigation into Cancer and Nutrition Study Food Frequency Questionnaire (EPIC-FFQ) | (EPIC-FFQ) | 3, 12, 24, 36 months |
| serum cholesterol, serum high density lipoprotein cholesterol,serum, serum Glucose, triglycerides, c-reactive Protein, serum Insulin,proneurotensin | Blood Test | 3, 12, 24, 36 months |
| proenkephalin | Genetic test | 3, 12, 24, 36 months |
| Omega 3 fatty acid in the erythrocyte Membrane, Omega 6 fatty acid level in the erythrocyte Membraserum low density, lipoprotein cholesterolne, Omega 9 fatty acid level in the erythrocyte Membrane, | Blood Test | 3, 12, 24, 36 months |
| Universitaet Hohenheim, Stuttgart |
| Study Director |
| Michael Siniatchkin, Prof. Dr. | University Hospital Schleswig-Holstein | Study Director |
| Markus Loeffler, Prof. Dr. | University of Leipzig | Study Director |
| Christoph Engel, PD Dr. | University of Leipzig | Study Director |
| Rita K Schmutzler, Prof. Dr. | University of Cologne | Study Director |
| Alfons Meindl, Prof. Dr. | Technical University of Munich | Study Director |
| Anne S Quante, Dr. | Technical University of Munich | Principal Investigator |
| Recruiting |
| Cologne |
| Germany |
| Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Recruiting | Dresden | Germany |
| Universitätsklinikum Düsseldorf | Recruiting | Düsseldorf | Germany |
| Kliniken Essen-Mitte | Recruiting | Essen | Germany |
| Universitätsklinikum Essen | Recruiting | Essen | Germany |
| Universitätsklinikum Freiburg | Recruiting | Freiburg im Breisgau | Germany |
| Universitätsmedizin Göttingen | Recruiting | Göttingen | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | Germany |
| Medizinische Hochschule Hannover | Recruiting | Hanover | Germany |
| Universitätsklinium Heidelberg | Recruiting | Heidelberg | Germany |
| Universitätsklinikum Schleswig-Holstein, Campus Kiel | Recruiting | Kiel | Germany |
| Universitätsklinikum Leipzig | Not yet recruiting | Leipzig | Germany |
| Technische Universität München | Recruiting | München | Germany |
| Universität Regensburg | Recruiting | Regensburg | Germany |
| Interdisziplinäres Brustzentrum am Diakonieklinikum | Recruiting | Stuttgart | Germany |
| Universitätsklinikum Tübingen | Recruiting | Tübingen | Germany |
| Universität Ulm | Recruiting | Ulm | Germany |
| Universitätsklinikum Würzburg | Recruiting | Würzburg | Germany |
| Kiechle M, Engel C, Berling A, Hebestreit K, Bischoff SC, Dukatz R, Siniatchkin M, Pfeifer K, Grill S, Yahiaoui-Doktor M, Kirsch E, Niederberger U, Enders U, Loffler M, Meindl A, Rhiem K, Schmutzler R, Erickson N, Halle M. Effects of lifestyle intervention in BRCA1/2 mutation carriers on nutrition, BMI, and physical fitness (LIBRE study): study protocol for a randomized controlled trial. Trials. 2016 Jul 29;17:368. doi: 10.1186/s13063-016-1504-0. |
| ID | Term |
|---|---|
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
Not provided
Not provided