Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490367
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
Time-Restricted Eating in Huntingtons Disease A Clinical Pilot Study
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
Safety Feasibility and Biomarker Effects of Time-restricted Eating for 12 Weeks in Early-stage Huntingtons Disease
Status:
RECRUITING
Status Verified Date:
2024-08
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:
TREHD
Brief Summary:
This trial examines whether 12 weeks of time-restricted eating TRE otherwise known as intermittent fasting appears safe and feasible in persons with early-stage Huntingtons disease HD The study also explores the effects of TRE on biomarkers and clinical measures associated with HD progression
Detailed Description:
OBJECTIVES
I Examine the feasibility and tolerability of TRE through measures of protocol implementation adherence rates and adverse events
II Evaluate the safety of short-term TRE in the early stages of Huntingtons disease HD by measures of body composition vital signs and blood analysis
III Analyze biomarker dynamics via peripheral markers of neurodegeneration and explore bioenergetic effects of TRE via measures of mitochondrial function
IV Explore whether TRE has effects on behavioral cognitive and motor function outcomes using standard HD clinical scales
OUTLINE
This study is a prospective interventional open-label single-arm trial Enrolled participants are asked to engage in a TRE diet specifically maintaining a 6-8-hour eating window every day for 12 weeks Participants are allowed to self-select the timing of the eating window but once selected they are asked to maintain that schedule daily Outside of that window for the remaining 16-18 hours of daynight participants are asked not to consume calorie-containing food or drink Beverages without calories are allowed The investigators measure body weight and composition safety labs adherence to the diet dietary composition sleep physical activity mood biomarkers and clinical outcomes Data collection episodes take place at the Oregon Clinical and Translational Research Institute OCTRI within 7 days before the start of the study and again within 7 days after 12 weeks of TRE Participants complete study surveys directly in Qualtrics
I Examine the feasibility and tolerability of TRE through measures of protocol implementation adherence rates and adverse events
II Evaluate the safety of short-term TRE in the early stages of Huntingtons disease HD by measures of body composition vital signs and blood analysis
III Analyze biomarker dynamics via peripheral markers of neurodegeneration and explore bioenergetic effects of TRE via measures of mitochondrial function
IV Explore whether TRE has effects on behavioral cognitive and motor function outcomes using standard HD clinical scales
OUTLINE
This study is a prospective interventional open-label single-arm trial Enrolled participants are asked to engage in a TRE diet specifically maintaining a 6-8-hour eating window every day for 12 weeks Participants are allowed to self-select the timing of the eating window but once selected they are asked to maintain that schedule daily Outside of that window for the remaining 16-18 hours of daynight participants are asked not to consume calorie-containing food or drink Beverages without calories are allowed The investigators measure body weight and composition safety labs adherence to the diet dietary composition sleep physical activity mood biomarkers and clinical outcomes Data collection episodes take place at the Oregon Clinical and Translational Research Institute OCTRI within 7 days before the start of the study and again within 7 days after 12 weeks of TRE Participants complete study surveys directly in Qualtrics
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