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ACTIVE NOT RECRUITING
NCT05968144
PHASE1/PHASE2

Towards Understanding Between ADT Treatment, Circadian Rhythm, and Physiological Responsiveness

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

Frailty is one of the main reasons older adults lose independence. Frailty describes a reduced ability to withstand stress on the physiological scale, or a reduced physiological reserve. The theory is that entrainment of circadian rhythm via time-restricted eating will improve the body's ability to predict energy supply and demand, and therefore enable the body to allocate more resources to anabolic processes and promote resilience to cancer treatment, thereby preventing the progression of frailty. A total of 30 individuals over 55 years old undergoing ADT therapy for prostate cancer will be recruited. Participants will be randomized 1:1 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention. At baseline and post-intervention, Fried's Frailty Index will be used to assess frailty, and a novel set of five physiological responsiveness measures will be used to assess physiological responsiveness-1) lying-to-standing blood pressure, 2) heart rate variability, 3) oral glucose tolerance test, 4) 24-hour circadian cortisol rhythm, and 5) usual vs. fast gait speed. These data will allow assessment of 1) the feasibility of TRE among patients with prostate cancer during ADT treatment with the ultimate goal of optimizing an intervention to prevent the progression of frailty, and 2) the effects of TRE vs. control on frailty and physiological responsiveness.

Official title: ADRIAN: Towards Understanding of ADT Treatment and Dietary Patterns, Circadian Rhythm, Physiological Responsiveness, and Frailty

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-01-29

Completion Date

2027-12-31

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

Dietary recommendations

One-on-one meeting with a nutritionist to discuss and personalize dietary recommendations for patients with prostate cancer undergoing ADT.

BEHAVIORAL

Time-restricted eating

12 weeks of time-restricted eating (10-hour window)

Locations (1)

University of Maryland, Baltimore

Baltimore, Maryland, United States