Time-Restricted Eating for Huntington's Disease

(TREHD Trial)

Overseen By Russell Wells, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Cognitive impairment, Psychosis, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is time-restricted eating safe for humans?

Research on time-restricted eating, including variations like intermittent fasting and ketogenic diets, suggests it is generally safe for humans. A case study of a man with Huntington's disease who followed a time-restricted ketogenic diet for 48 weeks reported no significant adverse effects, and his weight remained stable. ^{1 2 3 4 5}

How does time-restricted eating differ from other treatments for Huntington's disease?

Time-restricted eating (TRE) is unique because it focuses on when you eat rather than what you eat, potentially improving brain and muscle metabolism and mitochondrial function, which may help with symptoms of Huntington's disease. Unlike traditional treatments, TRE is a dietary approach that doesn't involve medication and may offer benefits like improved motor symptoms and quality of life without significant side effects. ^{1 2 5 6 7}

What data supports the effectiveness of the Time-Restricted Eating Diet for Huntington's Disease?

Research suggests that dietary strategies like time-restricted eating and ketogenic diets can improve symptoms in Huntington's Disease. A case study showed improvements in motor symptoms, daily activities, and behavior in a patient following a time-restricted ketogenic diet. Additionally, dietary restriction has shown protective effects in mouse models of Huntington's Disease, improving motor function and reducing harmful gene expression. ^{1 2 3 5 6}

Who Is on the Research Team?

Amie Hiller, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This clinical trial is for individuals with early-stage Huntington's Disease who are interested in trying a time-restricted eating diet, also known as intermittent fasting, for 12 weeks. Specific eligibility criteria details were not provided.

Inclusion Criteria

I have a genetic test showing CAG repeat ≥ 36 without signs of juvenile Huntington's.

I am not pregnant and will use effective birth control.

I am at least 21 years old.

Exclusion Criteria

I have had brain surgery for Huntington's disease or another movement disorder.

I have significant blood, liver, heart, thyroid, or kidney disease.

I want to lose weight during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants engage in a time-restricted eating (TRE) diet for 12 weeks, maintaining a 6-8 hour eating window each day.

12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the TRE intervention, including biomarker analysis and clinical assessments.

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Time-Restricted Eating Diet

Trial Overview The study is testing the safety and feasibility of a time-restricted eating diet over a period of 12 weeks in people with early-stage Huntington's Disease. It will also assess how this diet affects certain biomarkers and clinical measures related to the disease's progression.

How Is the Trial Designed?

Group I: Time-Restricted Eating Experimental Treatment 1 Intervention

All participants are assigned to this arm.

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

A ketogenic diet (KD) in a mouse model of Huntington's disease (BACHD mice) improved sleep/wake cycles by increasing daytime sleep and enhancing sleep onset timing, which is significant given the common sleep disturbances in HD patients.

The KD also improved motor performance in tests and showed potential to delay disease progression, highlighting the importance of dietary interventions as a therapeutic strategy for managing Huntington's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary ketosis improves circadian dysfunction as well as motor symptoms in the BACHD mouse model of Huntington's disease. Whittaker, DS., Tamai, TK., Bains, RS., et al.[2023]

Dietary restriction (DR) in the YAC128 mouse model of Huntington's disease significantly improved metabolic and motor functions, correcting issues like increased body weight and impaired motor skills.

DR was associated with reduced levels of the harmful human HTT protein and changes in gene expression related to histone acetylation, suggesting a potential mechanism for its protective effects against Huntington's disease symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protection by dietary restriction in the YAC128 mouse model of Huntington's disease: Relation to genes regulating histone acetylation and HTT. Moreno, CL., Ehrlich, ME., Mobbs, CV.[2018]

In a study of 1001 premanifest Huntington disease carriers, adherence to the Mediterranean diet did not significantly affect the time to phenoconversion, indicating that this diet may not be a protective factor against the onset of Huntington disease.

However, higher dairy consumption was linked to a two-fold increased risk of phenoconversion, suggesting that certain dietary components may influence disease progression and warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship of Mediterranean diet and caloric intake to phenoconversion in Huntington disease. Marder, K., Gu, Y., Eberly, S., et al.[2021]

A 41-year-old man with progressive Huntington's disease showed significant improvements in motor symptoms (52% improvement) and daily living activities (28% improvement) after following a time-restricted ketogenic diet for 48 weeks.

The ketogenic diet also led to notable enhancements in behavior problems related to HD (50-100% improvement) and quality of life (25% improvement), with no significant adverse effects reported, indicating a potential safe dietary intervention for managing symptoms of HD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Ketogenic Diet in Huntington's Disease: A Case Study. Phillips, MCL., McManus, EJ., Brinkhuis, M., et al.[2022]

Huntington's disease (HD) patients have significantly higher energy intake compared to age- and gender-matched controls, with symptomatic patients consuming even more calories, indicating a potential link between dietary habits and disease severity.

The study found differences in adherence to the Mediterranean Diet (MD) between HD patients and controls, suggesting that dietary patterns may influence disease outcomes and highlighting the need for nutritional education in managing HD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the Dietary Intake Using the CyFFQ Semi-Quantitative Food Frequency Questionnaire in Cypriot Huntington's Disease Patients. Christodoulou, CC., Demetriou, CA., Philippou, E., et al.[2023]

In a study of 43 presymptomatic individuals with a genetic risk for Huntington disease, those who later developed motor symptoms had significantly lower brain glucose metabolism in the caudate region compared to those who remained symptom-free, indicating a potential biomarker for disease onset.

The study found that measuring brain glucose uptake improved predictions of the age at onset of Huntington disease by 37%, suggesting that glucose metabolism may play a critical role in the progression of the disease beyond just genetic factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDG PET uptake in the pre-Huntington disease caudate affects the time-to-onset independently of CAG expansion size. Ciarmiello, A., Giovacchini, G., Orobello, S., et al.[2021]

Individuals with Huntington's disease often experience dysphagia, leading to the need for texture-modified diets, which can reduce sensory stimulation and enjoyment of food.

The commentary highlights two clinical interventions designed to enhance dietary satisfaction and encourage involvement in food preparation for people with Huntington's disease, suggesting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term use of Modified Diets in Huntington's Disease: A Descriptive Clinical Practice Analysis on Improving Dietary Enjoyment. Moorhouse, B., Fisher, CA.[2016]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary ketosis improves circadian dysfunction as well as motor symptoms in the BACHD mouse model of Huntington's disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Protection by dietary restriction in the YAC128 mouse model of Huntington's disease: Relation to genes regulating histone acetylation and HTT. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Relationship of Mediterranean diet and caloric intake to phenoconversion in Huntington disease. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Ketogenic Diet in Huntington's Disease: A Case Study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Investigating the Dietary Intake Using the CyFFQ Semi-Quantitative Food Frequency Questionnaire in Cypriot Huntington's Disease Patients. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

18F-FDG PET uptake in the pre-Huntington disease caudate affects the time-to-onset independently of CAG expansion size. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Long-Term use of Modified Diets in Huntington's Disease: A Descriptive Clinical Practice Analysis on Improving Dietary Enjoyment. [2016]