NCT03139227

Apigenin in Increasing Health Benefits in High Risk Breast Clinic Patients

Celery-Based Dietary Intervention: A Feasibility Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies the side effects and best dose of apigenin in increasing health benefits in high risk breast clinic patients. Celery is high in apigenin, a compound that may have anti-cancer activities. Eating a celery-based diet may help in prevention and treatment of inflammatory diseases including cancer.

Detailed description

PRIMARY OBJECTIVES; I. To determine the feasibility of apigenin oral supplementation using a specially formulated celery-banana bread. II. To determine the safety and tolerability of apigenin supplementation. OUTLINE: This is a dose-escalation study. Patients consume one serving of lower dose apigenin celery-banana bread daily on days 1-7, and then consume one serving of higher dose apigenin celery-banana bread on days 8-14. Patients undergo blood sample collection on day 1 prior to and 6 hours after bread ingestion, on day 8 prior to and 6 hours after ingestion of bread, and on day 15 (or endpoint). Patients also provide a baseline urine sample and then 24-hour urine samples on days 1, 7, 8, and 14.

Conditions

• Health Status Unknown

Interventions

Type	Name	Description
PROCEDURE	Bio specimen Collection	Patients undergo collection of blood and urine
DIETARY_SUPPLEMENT	Dietary Intervention	Consume celery-banana bread
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2017-08-15
• Primary completion: 2019-03-14
• Completion: 2019-03-14
• First posted: 2017-05-03
• Last updated: 2023-09-13