This clinical trial investigates if an anti-inflammatory fiber-rich dietary intervention and an exercise intervention may reduce inflammation among breast cancer survivors. A diet emphasizing fiber intake may be just as effective as or more effective than the traditional calorie-restriction approach to reducing risk factors for breast cancer recurrence.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05113485.
Locations matching your search criteria
United States
California
Los Angeles
UCLA / Jonsson Comprehensive Cancer CenterStatus: Active
Contact: William McCarthy
Phone: 310-794-7587
PRIMARY OBJECTIVE:
I. To reduce several cardiometabolic risk factors but the primary outcome measure is high sensitivity C-reactive protein, a measure of low-grade systemic inflammation.
SECONDARY OBJECTIVE:
I. Test whether the predicted change in cardiometabolic risk factors is mediated by changes in the composition of the study participants' gut microbiota.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive traditional calorie restriction dietary intervention and wear a Fitbit physical activity tracker to track exercise time for about 12-13 weeks.
ARM II: Patients receive high-fiber dietary intervention and wear a Fitbit physical activity tracker to track exercise time for about 12-13 weeks.
After completion of study treatment, patients are followed up at 30 days, and 3 and 6 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationUCLA / Jonsson Comprehensive Cancer Center
Principal InvestigatorWilliam McCarthy
