Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer (GeniPro)
|ClinicalTrials.gov Identifier: NCT02766478|
Recruitment Status : Suspended (Enrollment and study activities are temporarily suspended due to COVID-19.)
First Posted : May 9, 2016
Last Update Posted : May 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Genistein Drug: Placebo||Phase 2|
This is a double-blind, randomized, placebo-controlled trial of daily oral genistein in 24 men initiating Androgen Deprivation Therapy (ADT) for prostate cancer (PCa). Genistein is a natural supplement that comes from soy. The purpose of this study is to see if genistein has any effect on preventing or reducing heart disease and diabetes risk in men receiving ADT for PCa. A combination of nutritional measures, blood markers and imaging tools will assess body composition, lipid levels and insulin resistance. Information from this study will increase understanding of interventions which may prevent or reduce health risks during prostate cancer treatment.
All participants will receive standard counseling for diet and exercise by their oncology care team. Participants will be asked to withhold from any additional dietary supplements (with the exception of 1 standard daily multivitamin) during the study period. Participants will also be asked to complete a food diary for three days (on two weekdays and 1 weekend day).
Subjects will be randomized and stratified by diabetes status to either 60 mg/day oral genistein (30 mg taken twice daily), or matching placebo. The goal for randomizing based on diabetes status is to ensure approximately the same number of subjects who have diabetes and do not have diabetes receive genistein and placebo.
During follow-up, subjects will receive weekly reminders via phone call, text, or email to enhance compliance and monitor for potential adverse events. The 3-month study visit will be scheduled to coincide with the subject's standard of care follow-up visit. Three-month assessments will be the same as baseline assessments.
Investigators seek to assess indexes of insulin dynamics (insulin sensitivity and secretion) determined from an oral glucose tolerance test before and 12 weeks after a daily genistein or placebo supplement. Measures of vascular function before and 12 weeks after a daily genistein or placebo supplement will also be assessed via ultrasound along with other metabolic measures via blood draw.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Participants with and without diabetes will receive 60 mg/day oral genistein (30 mg taken twice daily) for 12 weeks.
Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.
Placebo Comparator: Placebo
Participants with and without diabetes will receive placebo taken twice daily for 12 weeks.
A placebo pill will be taken orally for 12 weeks.
- Change in Matsuda Index of Whole-Body Insulin Sensitivity [ Time Frame: Baseline, Week 12 ]The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT).
- Change in β-cell Insulin Secretion Capacity assessed by the Insulinogenic Index [ Time Frame: Baseline, Week 12 ]β-cell insulin secretion will be assessed by the insulinogenic index by measuring the ratio of insulin to glucose.
- Change in Arterial Stiffness [ Time Frame: Baseline, Week 12 ]Arterial stiffness will be assessed by applanation tonometry.
- Change in Vascular Endothelial Function [ Time Frame: Baseline, Week 12 ]Vascular endothelial function will be measured with flow-mediated dilation (FMD) via ultrasound.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766478
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Jessica Alvarez, PhD||Emory University|