Eleonora Bruno1, Andreina Oliverio1, Angelo Virgilio Paradiso2, Antonella Daniele3, Stefania Tommasi4, Antonio Tufaro3, Daniela Andreina Terribile5,6, Stefano Magno6, Alessio Filippone5, Elisabetta Venturelli1, Daniele Morelli7, Ivan Baldassari1, Maria Luisa Cravana1, Siranoush Manoukian8, Patrizia Pasanisi1. 1. Department of Research, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 20133 Milan, Italy. 2. Experimental Oncology, Center for Study of Heredo-Familial Tumors, IRCCS Istituto Tumori "Giovanni Paolo II", 70124 Bari, Italy. 3. Experimental Oncology and Biobank Management Unit, IRCCS Istituto Tumori "Giovanni Paolo II", 70124 Bari, Italy. 4. Molecular Diagnostics and Pharmacogenetics Unit, IRCCS Istituto Tumori "Giovanni Paolo II", 70124 Bari, Italy. 5. Department of Women Health Area, Università Cattolica S. Cuore, 00168 Rome, Italy. 6. Department of Women and Child Health and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, 00168 Rome, Italy. 7. Department of Diagnostic Pathology and Laboratory, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 20133 Milan, Italy. 8. Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, 20133 Milan, Italy.
Abstract
Background: Women carriers of BRCA1/2 mutations face a high lifetime risk (penetrance) of developing breast and/or ovarian cancer. Insulin-like growth factor I (IGF-I), body weight and markers of insulin resistance affect BRCA penetrance. We conducted a multicenter prospective two-armed (1:1) randomized controlled trial (NCT03066856) to investigate whether a Mediterranean dietary intervention with moderate protein restriction reduces IGF-I and other metabolic modulators of BRCA penetrance. Methods: BRCA carriers, with or without a previous cancer, aged 18-70 years and without metastases were randomly assigned to an active dietary intervention group (IG) or to a control group (CG). The primary endpoint of the intervention was the IGF-I reduction. Results:416 women (216 in the IG and 200 in the CG) concluded the six-month dietary intervention. The IG showed significantly lowered serum levels of IGF-I (-11.3 ng/mL versus -1.3 ng/mL, p = 0.02), weight (-1.5 Kg versus -0.5 Kg, p < 0.001), waist circumference (-2 cm versus -0.7 cm, p = 0.01), hip circumference (-1.6 cm versus -0.5 cm, p = 0.01), total cholesterol (-10.2 mg/dL versus -3.6 mg/dL, p = 0.04) and triglycerides (-8.7 mg/dL versus + 5.5 mg/dL, p = 0.01) with respect to the CG. Conclusions: A Mediterranean dietary intervention with moderate protein restriction is effective in reducing IGF-I and other potential modulators of BRCA penetrance.
RCT Entities:
Background: Women carriers of BRCA1/2 mutations face a high lifetime risk (penetrance) of developing breast and/or ovarian cancer. Insulin-like growth factor I (IGF-I), body weight and markers of insulin resistance affect BRCA penetrance. We conducted a multicenter prospective two-armed (1:1) randomized controlled trial (NCT03066856) to investigate whether a Mediterranean dietary intervention with moderate protein restriction reduces IGF-I and other metabolic modulators of BRCA penetrance. Methods:BRCA carriers, with or without a previous cancer, aged 18-70 years and without metastases were randomly assigned to an active dietary intervention group (IG) or to a control group (CG). The primary endpoint of the intervention was the IGF-I reduction. Results: 416 women (216 in the IG and 200 in the CG) concluded the six-month dietary intervention. The IG showed significantly lowered serum levels of IGF-I (-11.3 ng/mL versus -1.3 ng/mL, p = 0.02), weight (-1.5 Kg versus -0.5 Kg, p < 0.001), waist circumference (-2 cm versus -0.7 cm, p = 0.01), hip circumference (-1.6 cm versus -0.5 cm, p = 0.01), total cholesterol (-10.2 mg/dL versus -3.6 mg/dL, p = 0.04) and triglycerides (-8.7 mg/dL versus + 5.5 mg/dL, p = 0.01) with respect to the CG. Conclusions: A Mediterranean dietary intervention with moderate protein restriction is effective in reducing IGF-I and other potential modulators of BRCA penetrance.
Authors: F Berrino; C Bellati; G Secreto; E Camerini; V Pala; S Panico; G Allegro; R Kaaks Journal: Cancer Epidemiol Biomarkers Prev Date: 2001-01 Impact factor: 4.254
Authors: T Norat; L Dossus; S Rinaldi; K Overvad; H Grønbaek; A Tjønneland; A Olsen; F Clavel-Chapelon; M C Boutron-Ruault; H Boeing; P H Lahmann; J Linseisen; G Nagel; A Trichopoulou; D Trichopoulos; V Kalapothaki; S Sieri; D Palli; S Panico; R Tumino; C Sacerdote; H B Bueno-de-Mesquita; P H M Peeters; C H van Gils; A Agudo; P Amiano; E Ardanoz; C Martinez; R Quirós; M J Tormo; S Bingham; T J Key; N E Allen; P Ferrari; N Slimani; E Riboli; R Kaaks Journal: Eur J Clin Nutr Date: 2006-08-09 Impact factor: 4.016