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

May 30, 2025 updated by: Amie Hiller, MD, Oregon Health and Science University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Huntington's 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 day/night, 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Russell Wells, BS
  • Phone Number: (971) 378-7219
  • Email: TREHD@ohsu.edu

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Time-Restricted Eating
All participants are assigned to this arm.
Behavioral: Time-Restricted Eating Diet
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to the TRE diet.
Time Frame: Week 1 to Week 13
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in fat-free body mass.
Time Frame: Baseline, Week 13
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 plasma neurofilament light protein (NfL).
Time Frame: Baseline, Week 13
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).
Time Frame: Baseline, Week 13
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).
Time Frame: Baseline, Week 13
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
Change from baseline in the daily eating period.
Time Frame: Baseline, Week 13
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in comprehensive metabolic panel values.
Time Frame: Baseline, Week 13
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.
Time Frame: Baseline, Week 13
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.
Time Frame: Baseline, Week 13
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.
Time Frame: Baseline, Week 13
Hemoglobin A1c will be analyzed before and after the TRE intervention as a safety measure.
Baseline, Week 13
Change from baseline in creatinine clearance.
Time Frame: Baseline, Week 13
Creatinine clearance will be analyzed before and after the TRE intervention as a safety measure.
Baseline, Week 13
Change from baseline in body weight.
Time Frame: Baseline - Week 13
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
Time Frame: Baseline - Week 13
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
Time Frame: Baseline - Week 13
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
Time Frame: Baseline - Week 13
In a weekly survey, participants are asked to self-report various aspects of their mood.
Baseline - Week 13
Evaluation of cognitive function
Time Frame: Baseline, Week 13
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
Time Frame: Baseline - Week 13
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
Time Frame: Baseline, Week 13
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amie Hiller, MD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00026970

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is a plan to make all IPD that underlie results in a publication available.

IPD Sharing Time Frame

Starting June 2025

IPD Sharing Access Criteria

Access granted to study team and data steward.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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