Time-restricted eating in early-stage Huntington's disease: A 12-week interventional clinical trial protocol

Area of Science:

• Neuroscience and Neurology
• Metabolic and Nutritional Science
• Clinical Trial Design

Background:

• Huntington's disease (HD) is a progressive neurodegenerative disorder with no cure, necessitating novel therapeutic strategies.
• Lifestyle interventions, such as time-restricted eating (TRE), show promise for neurodegenerative diseases by improving cellular functions.
• The safety, feasibility, and efficacy of TRE in individuals with HD have not yet been established.

Purpose of the Study:

• To evaluate the adherence, safety, and feasibility of a 12-week time-restricted eating (TRE) intervention in participants with Huntington's disease.
• To assess the preliminary effects of TRE on biomarkers of neurodegeneration, body composition, and clinical measures of motor, cognitive, and behavioral function in HD patients.

Main Methods:

• A prospective, open-label, single-arm pilot study involving 25 participants with late prodromal or early manifest HD.
• Participants will adhere to a 6-8 hour eating window daily for 12 weeks.
• Data collection includes adherence monitoring, body composition, vital signs, safety labs, neurodegeneration biomarkers, and standardized clinical assessments for HD symptoms.

Main Results:

• This section is to be filled after the study's completion.
• Anticipated results include demonstrating the safety and feasibility of TRE in the HD population.
• Preliminary improvements in biomarkers and clinical measures are expected, warranting further investigation.

Conclusions:

• This pilot study is expected to provide crucial data on the safety and feasibility of time-restricted eating for individuals with Huntington's disease.
• Findings will inform the design of larger clinical trials to determine the therapeutic efficacy of TRE in slowing HD progression.
• TRE represents a promising, accessible lifestyle modification that may complement existing management strategies for Huntington's disease.