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.
Additional locations may be listed 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
