BRCA Main Home Nutritional Intervention-random Study
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|ClinicalTrials.gov Identifier: NCT03570125|
Recruitment Status : Unknown
Verified June 2018 by Antonio Russo, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo.
Recruitment status was: Recruiting
First Posted : June 26, 2018
Last Update Posted : June 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|BRCA1 Mutation BRCA2 Mutation||Dietary Supplement: Prolon||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||BRCA Main Home Nutritional Intervention-random Study|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||May 31, 2020|
Experimental: Dietary intervention arm
group will follow an ad libitum diet but, every two months, will follow a 5 day of fasting mimicking diet (PROLON). The diet consists of natural ingredients, which are Generally Regarded As Safe (GRAS).
Prolon will be provided for free by L-nutra or in case of unforeseeable budget constraint at one fifth of its commercial value.
Dietary Supplement: Prolon
The diet consists of natural ingredients, which are Generally Regarded As Safe (GRAS). In case the PROLON product will be unavailable at the time of the project we will design fasting mimicking diet without the usage of specifically designed commercial product
No Intervention: no intervention
Control/Placebo with multivitamin supplementation
- IGF1 [ Time Frame: 6 months ]IGF1 elisa test
- GH [ Time Frame: 6 months ]GH elisa test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03570125
|Contact: Mario G Mirisola, PhDemail@example.com|
|AOUP Paolo Giaccone||Recruiting|
|Palermo, Italy, 90127|
|Contact: Mario G Mirisola, PhD +393287538270 firstname.lastname@example.org|