Huntington DiseaseTREHDNCT06490367
Time-Restricted Eating in Huntington's Disease: A Clinical Pilot Study
A study testing Time-Restricted Eating Diet in people with Huntington Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Time-Restricted Eating Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: 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.
Read the detailed description
OBJECTIVES:
- 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.
- Conditions
- Huntington Disease
- Being tested
- Time-Restricted Eating Diet
- Keywords
- Time-restricted eating, Intermittent fasting, Time-restricted feeding, Dietary fasting
- Medical subject headings
- Huntington Disease, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted Eating DietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating | Experimental | All participants are assigned to this arm. Receives: Behavioral: Time-Restricted Eating Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1 to Week 13
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start29 Aug 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amie Hiller, MD, Oregon Health and Science University
- Investigators
- Amie Hiller, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490367
- Sponsor's protocol ID
- STUDY00026970
- Acronym
- TREHD
- Status last verified
- May 2025
- First submitted
- 29 Jun 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make all IPD that underlie results in a publication available.
Publications
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.
PubMed 38561866Wells 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.
PubMed 40131943
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Biomarker Effects of Time-restricted Eating for 12 Weeks in Early-stage Huntington's Disease.
- ClinicalTrials.gov ID
- NCT06490367
- Acronym / sponsor ID
- TREHD / STUDY00026970
- Conditions
- Huntington Disease
- Keywords
- Time-restricted eating, Intermittent fasting, Time-restricted feeding, Dietary fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating | Experimental | Behavioral: Time-Restricted Eating DietAll participants are assigned to this arm. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Are of at least 21 years of age at Screening.
- Must fulfill one of the following criteria:
- Must fulfill both of the following criteria:
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-Restricted Eating DietParticipants 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. | Behavioural | Time-Restricted Eating |
Primary outcome
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.
5 secondary outcomes
Change from baseline in fat-free body mass.
Time frame: Baseline, Week 13
Change from baseline in the daily eating period.
Time frame: Baseline, Week 13
Change from baseline in plasma neurofilament light protein (NfL).
Time frame: Baseline, Week 13
Change from baseline in plasma glial fibrillary acidic protein (GFAP).
Time frame: Baseline, Week 13
Change from baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS).
Time frame: Baseline, Week 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 38561866Wells 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.
- Derived from this study: PubMed 40131943Wells 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.
- Individual participant dataSharing planned: Yes. There is a plan to make all IPD that underlie results in a publication available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amie Hiller, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-Restricted Eating Diet in people with Huntington Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the TRE diet. (time frame: Week 1 to Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06490367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.