COMPLETED

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

Conditions

Huntington Disease Time-restricted eating Intermittent fasting Time-restricted feeding Dietary fasting

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-08-29

Study Completion:2025-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06490367

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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) 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.	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.

Inclusion Criteria

Exclusion Criteria

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)
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.

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.

Contacts and Locations

Principal Investigator

Amie Hiller, MD

PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Study Locations (Sites)

Oregon Health and Science University

Portland, Oregon, 97239

United States

Collaborators and Investigators

Sponsor: Oregon Health and Science University

Amie Hiller, MD, PRINCIPAL_INVESTIGATOR, Oregon Health and Science University

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 Registration Dates

Study Start Date2024-08-29

Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-08-29

Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Huntington Disease