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NCT02766478 · ClinicalTrials.gov registry record · Phase 2

Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer

A Phase 2 study, sponsored by Emory University.

Terminated
Registry status
Phase 2
Development phase
10
Enrollment target

NCT02766478: Clinical Trial Phase 2 study, sponsored by Emory University.

NCT02766478 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02766478, a Phase 2 study, was terminated before completion, sponsored by Emory University.

TERMINATED
Registry status
Phase 2
Development phase
10 participants
Enrollment target

Study Summary

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 Androgen Deprivation Therapy for prostate cancer. A combination of nutritional measures, blood markers and imaging tools will assess body composition, lipid levels and insulin resistance. Information from this pilot study will increase understanding of interventions which may prevent or reduce health risks during prostate cancer treatment. This project involves 24 men who will receive androgen deprivation therapy for prostate cancer.

Primary Outcome

The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT). Insulin sensitivity was calculated at baseline and after 8 weeks with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. Higher values are reflective of better insulin sensitivity. This test is not used to clinically diagnose disease, and there is no accepted, standard cuto

Interventions

  • DRUG Placebo
  • DRUG Genistein

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2017-10-16
Est. Completion 2021-07-23
Phase Phase 2
Emory University

1,208 total trials

Why NCT02766478 stopped before completion

NCT02766478 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02766478 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02766478 about?

NCT02766478 is a clinical study titled "Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer". 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 Androgen Deprivation Therapy for prostate cancer. A combination of nutritional measures, blood markers and...

What is the current status of trial NCT02766478?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2017-10-16. Estimated completion is 2021-07-23.

What interventions are being tested in trial NCT02766478?

The interventions under investigation include: Placebo (DRUG), Genistein (DRUG).

Who is sponsoring clinical trial NCT02766478?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02766478's enrollment target sits among peer trials

10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02766478, the US trial registry maintained by the National Library of Medicine. NCT02766478 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.