Time-Restricted Eating in Huntington's Disease: A Clinical Pilot Study
NCT Number: NCT06490367
Acronym: TREHD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Huntington Disease
Interventions: BEHAVIORAL: Time-Restricted Eating Diet
Sponsor: Oregon Health and Science University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2025-06
Locations: Oregon Health and Science University, Portland, Oregon, 97239, United States

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 Huntington's disease (HD). The study also explores the effects of TRE on biomarkers and clinical measures associated with HD progression.

Primary Outcome Measures: Adherence to the TRE diet., Adherence, measured as the number of days participants can successfully limit the eating window to 6-8 hours as tracked through self-reported surveys and time-stamped meal logs, is calculated for each participant during the 12 weeks of TRE., Week 1 to Week 13
Secondary Outcome Measures: Change from baseline in fat-free body mass., Using bioelectrical impedance analysis, body composition, and specifically, fat-free mass (lean body mass), is measured before and after the TRE intervention., Baseline, Week 13|Change from baseline in the daily eating period., The time period that participants consume calories within (from first consumption to last in the 24-hour day) is measured through retrospective survey analysis and during the lead-in week prior to the time-restricted eating (TRE) intervention. This is compared to the duration of the eating period during the 12 weeks of TRE, where participants are asked to limit the period to only 6-8 hours, while fasting the remainder of the 24 hour day., Baseline, Week 13|Change from baseline in plasma neurofilament light protein (NfL)., NfL is a marker of neurodegeneration and can be detected peripherally in the blood. Levels of NfL are measured before and after the TRE intervention., Baseline, Week 13|Change from baseline in plasma glial fibrillary acidic protein (GFAP)., GFAP is a marker of neurodegeneration and can be detected peripherally in the blood. Levels of GFAP are measured before and after the TRE intervention., Baseline, Week 13|Change from baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS)., cUHDRS includes the Total Functional Capacity (range, 0-13; higher score means better functioning), Total Motor Score (range, 0-124; higher score means worse motor severity), Symbol Digit Modality Test (range, 0-110, correctly paired numbers-symbols in 90 seconds; higher score means better cognitive performance), and Stroop Word Reading (range, 0-no max value, correctly read color words in 45 seconds; higher score means better cognitive performance) scores. A z-score for each test is calculated, which alone can be used to describe relationship between an individual's test score and the mean score of a target population., Baseline, Week 13
Other Outcome Measures: Change from baseline in comprehensive metabolic panel values., A CMP will be drawn and analyzed before and after the TRE intervention as a safety measure., Baseline, Week 13|Change from baseline in complete blood count values., A CBC will be drawn and analyzed before and after the TRE intervention as a safety measure., Baseline, Week 13|Change from baseline in lipid panel values., A lipid panel will be drawn and analyzed before and after the TRE intervention as a safety measure., Baseline, Week 13|Change from baseline in hemoglobin A1c., Hemoglobin A1c will be analyzed before and after the TRE intervention as a safety measure., Baseline, Week 13|Change from baseline in creatinine clearance., Creatinine clearance will be analyzed before and after the TRE intervention as a safety measure., Baseline, Week 13|Change from baseline in body weight., Participants are asked to self-report their body weight in a weekly survey. Every other week during the study, participants are contacted by telephone to discuss any at-home body weight changes., Baseline - Week 13|Evaluation of dietary composition, Twice per week, and each day during the lead-in period, participants are asked to use the SnapCalorie phone application to capture the meals eaten in a given day. Using the application, participants are asked to take photos of each meal, manually log foods, and report estimated serving sizes. Results are used to estimate caloric intake, and daily consumed fats, carbohydrates, and proteins., Baseline - Week 13|Evaluation of sleep, In a daily survey, participants are asked to self-report sleep duration. In a weekly survey, participants are asked to complete the Epworth Sleepiness Scale questionnaire., Baseline - Week 13|Evaluation of mood, In a weekly survey, participants are asked to self-report various aspects of their mood., Baseline - Week 13|Evaluation of cognitive function, The Montreal Cognitive Assessment (MoCA) is a validated test used to measure cognitive function. It is administered before and after the TRE intervention at the baseline and follow-up visits., Baseline, Week 13|Evaluation of physical activity, In a weekly survey, participants are asked to self-report the amount and type of exercise they engaged in during the previous seven days., Baseline - Week 13|Evaluation of mitochondrial function, Using cryopreserved peripheral blood mononuclear cells (PBMCs) isolated from participant whole blood samples drawn at the baseline and follow-up visits, mitochondrial function and electron transport chain activity are assessed with the SeahorseXF analyzer., Baseline, Week 13