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BRCA Main Home Nutritional Intervention-random Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Antonio Russo, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Brief Summary:
Women carrying harmful mutation in BRCA1 or BRCA2 gene are at higher risk to develop breast and/or ovarian cancer than the general population. Many observations lead to the hypothesis that breast cancer risk may be increased in women with elevated plasma insulin-like growth factor 1 (IGF-1) and insulin levels. Targeting the IGF system is therefore a promising anticancer therapy and a new tool for oncologists. Evidence from bio-gerontology research from our laboratories show that cycles of short-term fasting/starvation (STS) or low calorie diet can improve health span of laboratory animals, whose effect is partly mediated by reduced circulating IGF-1. Investigators in our group have demonstrated that protein consumption, especially animal proteins, increases IGF-1 level and is associated with elevated cancer risk in a US cohort ranging from age 50 to 65 (PMID: 26094889). It was also showed that alternating prolonged fasting and nutrient-rich medium extended yeast lifespan independently of the status of the established pro-longevity genes. Prolonged Fasting (PF) has also been shown in preliminary studies to decrease the side effects of chemotherapy, an effect now being tested in multiple larger randomized clinical trials (PMID: 26590477). The main hypothesis of this proposal is that a combination of protein restriction, fasting, fasting mimicking diet (FMD), and restriction of specific amino acids may be able to decrease cancer incidence in a cohort of people at high risk of developing tumors (BRCA1/2). Our group plan to verify the safety, effectiveness and impact of a specially formulated longevity dietary regimen (low protein fish- and plant-based) and of FMD repeated cycles on the levels of endogenous hormones in a cohort of people at increased cancer risk. Since the duration of the project will not give us the opportunity to directly measure cancer incidence in humans we will test: 1a) the variation of a number of widely recognized susceptibility biomarkers predictive of cancer incidence in a cohort human carriers of BRCA1/2 mutations in response to the dietary interventions; 1b) cancer incidence and progression in genetically engineered mice (K14Cre Brca1flox/flox Trp53+/flox and K14Cre Brca1+/flox Trp53-/- mice) predisposed to develop hereditary breast cancer in response to corresponding dietary interventions. Investigators will also test epigenetic alterations associated with these interventions in: 2a) DNA samples from muscle biopsies of a subgroup of humans; 2b) breast epithelial tissue in mice.

Condition or disease Intervention/treatment Phase
BRCA1 Mutation BRCA2 Mutation Dietary Supplement: Prolon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. IGF1 [ Time Frame: 6 months ]
    IGF1 elisa test

  2. GH [ Time Frame: 6 months ]
    GH elisa test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

BRCA1 mutation carrier BRCA 2 mutation carrier

Exclusion Criteria:

diabetes anorexic under treatment for glycemic control


Information from the National Library of Medicine

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


Contacts
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Contact: Mario G Mirisola, PhD +393287538270 mario.mirisola@unipa.it

Locations
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Italy
AOUP Paolo Giaccone Recruiting
Palermo, Italy, 90127
Contact: Mario G Mirisola, PhD    +393287538270    mario.mirisola@unipa.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Publications of Results:
Other Publications:
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Responsible Party: Antonio Russo, Full Professor, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
ClinicalTrials.gov Identifier: NCT03570125    
Other Study ID Numbers: CEP1:4/2016
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No