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Behavioral Intervention

Time-Restricted Eating for Prostate Cancer Survivorship (ADRIAN Trial)

Phase 1 & 2

Recruiting

Led By Amber Kleckner, PhD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if eating at regular times helps prevent frailty in older adults with prostate cancer receiving hormone therapy. 30 participants will be tested for frailty and physiological responses.

Who is the study for?

This trial is for individuals over 55 with prostate cancer undergoing ADT therapy who can follow the study procedures and speak/read English. It's not for those who already eat within a 10-hour window, have upcoming surgery, contraindications to diet changes (like type 1 diabetes), are on artificial nutrition, underweight, or have had significant weight loss recently.

What is being tested?

The study tests if time-restricted eating can help older adults better handle stress from frailty and prostate cancer treatment. Participants will either follow a strict eating schedule or their usual habits for 12 weeks while researchers measure changes in frailty and physiological responses like blood pressure and glucose tolerance.

What are the potential side effects?

Since this trial involves dietary interventions rather than medication, side effects may include hunger outside of eating windows, potential temporary digestive adjustments to new eating schedules, and possible fluctuations in energy levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility, as assessed by the percentage of participants who enrolled completed the study

Secondary study objectives

The effects of TRE on frailty, as measured using Fried's Frailty criteria

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time-restricted eatingExperimental Treatment2 Interventions

Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will self-select a 10-hour window in which to consume all food and beverages (with the exception of black coffee and unsweetened tea in the mornings; water is okay at all times).

Group II: Unrestricted eatingActive Control1 Intervention

Participants will meet with a nutritionist to discuss dietary recommendations for patients with prostate cancer undergoing ADT. Participants will try to follow recommendations will no suggestion for meal timing.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dietary recommendations

2019

N/A

~390

Time-restricted eating

2022

N/A

~850