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Behavioral Intervention

Time-Restricted Eating for Huntington's Disease (TREHD Trial)

N/A
Recruiting
Led By Amie Hiller, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have undergone genetic testing with known CAG repeat ≥ 36 and no features of juvenile HD
Subjects must be at least 21 years of age at Screening
Must not have
Subjects with clinically significant cognitive impairment that hinders the ability to consent or adhere to study directions
Subjects who have had previous neurosurgery for Huntington's disease or other movement disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 to week 13
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if intermittent fasting for 12 weeks is safe and doable for people with early-stage Huntington's disease. It also looks at how intermittent fasting may affect the biomarkers and clinical

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects were not detailed but may include hunger, fatigue, or other symptoms associated with changes in dietary patterns due to intermittent fasting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a genetic test showing CAG repeat ≥ 36 without signs of juvenile Huntington's.
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I am at least 21 years old.
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I have Huntington's disease with specific genetic markers and early symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any cognitive issues that prevent me from following study instructions.
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I have had brain surgery for Huntington's disease or another movement disorder.
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I have significant blood, liver, heart, thyroid, or kidney disease.
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I have severe mental health issues, like psychosis or confusion.
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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 to week 13
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 to week 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adherence to the TRE diet.
Secondary study objectives
Change from baseline in fat-free body mass.
Change from baseline in plasma glial fibrillary acidic protein (GFAP).
Change from baseline in plasma neurofilament light protein (NfL).
+2 more
Other study objectives
Change from baseline in body weight.
Change from baseline in complete blood count values.
Change from baseline in comprehensive metabolic panel values.
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Time-Restricted EatingExperimental Treatment1 Intervention
All participants are assigned to this arm.

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,006 Previous Clinical Trials
7,413,894 Total Patients Enrolled
Amie Hiller, MDPrincipal InvestigatorOregon Health and Science University
1 Previous Clinical Trials
8 Total Patients Enrolled
~12 spots leftby Mar 2025
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