Time-Restricted Eating in Huntington's Disease: A Clinical Pilot Study

NCT06490367 | Completed DMC

• 1 other identifier: STUDY00026970
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Conditions

Huntington Disease

Keywords

Time-restricted eating; Intermittent fasting; Time-restricted feeding; Dietary fasting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in fat-free body mass.

  Baseline, Week 13

• Change from baseline in the daily eating period.

  Baseline, Week 13

• Change from baseline in plasma neurofilament light protein (NfL).

  Baseline, Week 13

• Change from baseline in plasma glial fibrillary acidic protein (GFAP).

  Baseline, Week 13

• Change from baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS).

  Baseline, Week 13

Other Outcomes (12)

• Change from baseline in comprehensive metabolic panel values.

  Baseline, Week 13

• Change from baseline in complete blood count values.

  Baseline, Week 13

• Change from baseline in lipid panel values.

  Baseline, Week 13

Study Arms (1)

Time-Restricted Eating

EXPERIMENTAL

All participants are assigned to this arm.

Behavioral: Time-Restricted Eating Diet

Interventions

Time-Restricted Eating Diet BEHAVIORAL

Participants engage in a time-restricted eating 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 day/night, participants are asked not to consume calorie-containing food or drink. Beverages without calories are allowed.

Time-Restricted Eating

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible to participate in this study are persons who:
• Are of at least 21 years of age at Screening.
• Must fulfill one of the following criteria:
• 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)).
• 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.
• Must fulfill both of the following criteria:
• Have undergone genetic testing with a known CAG repeat greater than or equal to 36.
• 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.
• 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.
• Are willing and capable of providing informed consent for study participation.
• Are capable of reading, writing, and communicating effectively with others.

You may not qualify if:

• Subjects ineligible to participate in this study are persons who:
• Have participated in an investigational drug or device study within 30 days of the baseline visit
• Have had previous neurosurgery for Huntington's disease or other movement disorders.
• 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.
• Have a presence of clinically significant psychosis and/or confusional states, in the opinion of the principal investigator.
• Have clinically relevant hematologic, hepatic, cardiac, thyroid, or renal disease.
• Have a history of substance abuse (based on DSMIV criteria) within the past 12 months prior to screening.
• If female, are pregnant or breastfeeding.
• Have a high-risk for nutritional deficiency.
• 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.
• Express a desire to lose weight during the study.
• 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.
• Have consistently practiced a time-restricted eating protocol within 3 months of trial onset.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

• Wells RG, Neilson LE, McHill AW, Hiller AL. Dietary fasting and time-restricted eating in Huntington's disease: therapeutic potential and underlying mechanisms. Transl Neurodegener. 2024 Apr 2;13(1):17. doi: 10.1186/s40035-024-00406-z.

  PMID: 38561866 BACKGROUND

• Wells RG, Neilson LE, McHill AW, Hiller AL. Time-restricted eating in early-stage Huntington's disease: A 12-week interventional clinical trial protocol. PLoS One. 2025 Mar 25;20(3):e0319253. doi: 10.1371/journal.pone.0319253. eCollection 2025.

  PMID: 40131943 DERIVED

MeSH Terms

Conditions

Huntington Disease; Intermittent Fasting

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Fasting; Feeding Behavior; Behavior

Study Officials

• Amie Hiller, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 8, 2024
• Study Start: August 29, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting June 2025
• Access Criteria: Access granted to study team and data steward.

Locations

US (1)