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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
ADRIAN Trial 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.Check my eligibility
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.See study design
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.
ADRIAN Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility, as assessed by the percentage of participants who enrolled completed the study
Secondary outcome measures
The effects of TRE on frailty, as measured using Fried's Frailty criteria
ADRIAN 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
~150
Time-restricted eating
2022
N/A
~520
Find a Location
Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,626 Total Patients Enrolled
2 Trials studying Frailty
129 Patients Enrolled for Frailty
Amber Kleckner, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
1 Previous Clinical Trials
54 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have unintentionally lost more than 10 pounds in the past year.I am scheduled for surgery during the study.I don't have conditions like type 1 diabetes or eating disorders that would make the nutrition plan unsafe for me.I am receiving my nutrition through artificial means.I have been diagnosed with prostate cancer.I am currently receiving hormone therapy to lower testosterone.I am 55 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Unrestricted eating
- Group 2: Time-restricted eating
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has recruitment for this trial been opened up to the public?
"The information hosted on clinicaltrials.gov confirms that the recruitment phase for this trial has terminated; it was originally posted on January 1, 2024 and last updated July 21, 2023. However, there are still 1676 other trials open to enrollees at present."
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