Back to Search Results- Recruiting
- Supportive care
- Interventional
- Randomized
- Behavioral
- PHASE1/PHASE2
- University of Maryland, Baltimore
- 55 Years -
Study Purpose
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.
Intervention
Behavioral : Dietary recommendations
Behavioral : Time-restricted eating
Eligibility Requirements
Have a diagnosis of prostate cancer
Be undergoing androgen deprivation therapy
Be 55 years old or older
Speak and/or read English
Be able and willing to adhere to the study procedures
Minimum age: 55
Already eat all their food in a window that is 10 h or shorter on most (6/7) days of the week
Be underweight (≤18.5 kg/m2)
Have surgery planned during the study duration
Have lost more than 10 pounds unintentionally in the last 12 months
Have any contraindications to the proposed nutrition intervention as identified by their medical provider, their designee, or the study team (e.g., type 1 diabetes, risk for hypoglycemia, medication requirements, recent history of an eating disorder)
Be on artificial nutrition
Recruiting status
Recruiting
Estimated enrollment
30
Study start date
Jan 29, 2024
Study end date
Dec 31, 2027
Last updated
Mar 23, 2025
Primary purpose
Supportive care
Design
Interventional
Intervention
Behavioral
Study phase
PHASE1/PHASE2
Allocation
Randomized
Sponsor:
University of Maryland, Baltimore
Collaborator:
N/A
Investigator:
Amber Kleckner, PhD
N/A
Publications
N/A
Websites
N/A
NCT05968144
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