Time-restricted eating for people with Huntington's disease

Safety, Feasibility, and Biomarker Effects of Time-restricted Eating for 12 Weeks in Early-stage Huntington's Disease.

This study is testing if a 12-week time-restricted eating plan can be safe and helpful for people with early-stage Huntington's disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Oregon Health and Science University (other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06490367 on ClinicalTrials.gov

What this trial studies

This clinical pilot study investigates the safety and feasibility of a 12-week time-restricted eating (TRE) regimen in individuals with early-stage Huntington's disease. Participants will follow a daily eating window of 6-8 hours while avoiding calorie-containing foods outside this period. The study aims to assess adherence to the diet, monitor adverse events, and evaluate changes in biomarkers and clinical measures related to Huntington's disease progression. Data will be collected before and after the intervention to analyze the effects on body composition, vital signs, and cognitive and motor functions.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21 and older with early-stage or premanifest Huntington's disease confirmed by genetic testing.

Not a fit: Patients with juvenile Huntington's disease or those without a confirmed genetic diagnosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel dietary intervention to slow the progression of Huntington's disease and improve patient outcomes.

How similar studies have performed: While time-restricted eating has shown promise in other populations, this specific application in Huntington's disease is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

Subjects eligible to participate in this study are persons who:

1. Are of at least 21 years of age at Screening.
2. Must fulfill one of the following criteria:

   1. Premanifest late prodromal HD as defined by a genetically confirmed CAG repeat greater than or equal to 36 and a CAG-Age Product (CAP) score greater than 368 (CAP = (Age) x (CAG - 33.66)).
   2. Early manifest (stage I and II) HD as defined by a TFC greater than or equal to 7. Subjects must have been determined to have a clinical diagnosis of HD by the site investigator as defined by a diagnostic confidence level (DCL) of 4.
3. Must fulfill both of the following criteria:

   1. Have undergone genetic testing with a known CAG repeat greater than or equal to 36.
   2. No features of juvenile HD (Westphal variant)

   Clarification of CAG Repeat Number (Allele length) Testing Requirements:

   A CAG repeat number obtained prior to the Screening Visit will be used to document subject eligibility if at Screening there is documentation available in the subject's record that states that the subject has an expanded CAG repeat (greater than or equal to 36) from a prior validated laboratory assessment.
4. All female subjects of childbearing potential must have a negative urine pregnancy test at baseline, and female subjects of childbearing potential must practice a highly effective method of contraception (e.g., oral contraceptives, a barrier method of birth control \[e.g. condoms with contraceptive foams, diaphragms with contraceptive jelly\], intrauterine devices, partner with vasectomy or sexual abstinence) for the duration of the study.
5. Are willing and capable of providing informed consent for study participation.
6. Are capable of reading, writing, and communicating effectively with others.

Exclusion Criteria:

Subjects ineligible to participate in this study are persons who:

1. Have participated in an investigational drug or device study within 30 days of the baseline visit
2. Have had previous neurosurgery for Huntington's disease or other movement disorders.
3. Have clinically significant cognitive impairment that hinders the ability to appropriately consent or adhere to detailed study directions, in the opinion of the principal investigator.
4. Have a presence of clinically significant psychosis and/or confusional states, in the opinion of the principal investigator.
5. Have clinically relevant hematologic, hepatic, cardiac, thyroid, or renal disease.
6. Have a history of substance abuse (based on DSMIV criteria) within the past 12 months prior to screening.
7. If female, are pregnant or breastfeeding.
8. Have a high-risk for nutritional deficiency.
9. Are not weight stable for at least three months prior to enrolling in the study, defined as greater than 2 kg change in body mass.
10. Express a desire to lose weight during the study.
11. Have a clinically significant medical, surgical, laboratory, or behavioral abnormality which in the judgment of the site Investigator makes the subject unsuitable for the study.
12. Have consistently practiced a time-restricted eating protocol within 3 months of trial onset.

Where this trial is running

Portland, Oregon

• Oregon Health and Science University — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Amie Hiller, MD — Oregon Health and Science University
• Study coordinator: Russell Wells, BS

Conditions: Huntington Disease, Time-restricted eating, Intermittent fasting, Time-restricted feeding, Dietary fasting