Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05968144
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-07-21
Brief Title:
Towards Understanding Between ADT Treatment Circadian Rhythm and Physiological Responsiveness
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
ADRIAN Towards Understanding of ADT Treatment and Dietary Patterns Circadian Rhythm Physiological Responsiveness and Frailty
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADRIAN
Brief 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 bodys 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 11 to a 12-week TRE intervention or a time-unrestricted nutrition control intervention At baseline and post-intervention Frieds 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
Detailed Description:
Frailty affects more than 54 million people over the age of 65 in the United States 10 and 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 It is characterized by five key signs and symptoms known as Frieds frailty criteria weakness slow walking speed low physical activity fatigue or exhaustion and unintentional weight loss Frailty does not progress linearly its pathogenesis often accelerates in response to a stressor event such as an illness eg coronavirus the death of a spouse or cancer treatment For example a diagnosis with prostate cancer and androgen deprivation therapy ADT treatment are associated with accelerated frailty While the body is resilient to everyday stressors these large-scale enduring stressors can accumulate and cause the body to have difficulty predicting energy supply and demand The result is that stress-induced energy costs compete with cellular growth maintenance and repair ie frailty Treatments for frailty are intensive eg weight training and often unsuccessful and there is a critical need to develop effective interventions to complement and replace these interventions to prevent and treat frailty
The theory is that entrainment of circadian rhythm or the bodys internal body clock will improve the bodys 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 Time-restricted eating TRE entails consuming food within a defined consistent window every day It has emerged as a powerful intervention to entrain circadian rhythm and regulate metabolic homeostasis The hypothesis is that by entraining circadian rhythm TRE can enhance physiological regulation and prevent stressor-induced frailty
A total of 30 patients over 55 years old undergoing ADT therapy for prostate cancer will be recruited Participants will be randomized 11 to a 12-week TRE intervention or a time- and attention nutrition control both groups will be under the supervision of a licensed clinical nutritionist with expertise in the cancer population to ensure adequate macronutrient intake At baseline and post-intervention a novel set of five physiological responsiveness measures and frailty using Frieds Frailty Index will be assessed These data will allow assessment of Aim 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 Aim 2 the effects of TRE on a Frieds Frailty Index b lying-to-standing blood pressure c heart rate variability d oral glucose tolerance e 24-hour circadian cortisol rhythm and f usual vs fast gait speed
This project is innovative and clinically important because once frailty is diagnosed it is difficult to treat This project tests a novel theoretical framework that a low cost widely accessible dietary intervention-TRE-can entrain circadian rhythm and improve physiological reserve in the context of ADT treatment for prostate cancer thereby preventing progression to frailty
The theory is that entrainment of circadian rhythm or the bodys internal body clock will improve the bodys 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 Time-restricted eating TRE entails consuming food within a defined consistent window every day It has emerged as a powerful intervention to entrain circadian rhythm and regulate metabolic homeostasis The hypothesis is that by entraining circadian rhythm TRE can enhance physiological regulation and prevent stressor-induced frailty
A total of 30 patients over 55 years old undergoing ADT therapy for prostate cancer will be recruited Participants will be randomized 11 to a 12-week TRE intervention or a time- and attention nutrition control both groups will be under the supervision of a licensed clinical nutritionist with expertise in the cancer population to ensure adequate macronutrient intake At baseline and post-intervention a novel set of five physiological responsiveness measures and frailty using Frieds Frailty Index will be assessed These data will allow assessment of Aim 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 Aim 2 the effects of TRE on a Frieds Frailty Index b lying-to-standing blood pressure c heart rate variability d oral glucose tolerance e 24-hour circadian cortisol rhythm and f usual vs fast gait speed
This project is innovative and clinically important because once frailty is diagnosed it is difficult to treat This project tests a novel theoretical framework that a low cost widely accessible dietary intervention-TRE-can entrain circadian rhythm and improve physiological reserve in the context of ADT treatment for prostate cancer thereby preventing progression to frailty
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None