NCT06490367已完成不适用
Safety, Feasibility, and Biomarker Effects of Time-restricted Eating for 12 Weeks in Early-stage Huntington's Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Adherence to the TRE diet.
研究概览
简要总结
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.
详细描述
OBJECTIVES:
I. Evaluate the safety of short-term time-restricted eating (TRE) in the early stages of Huntington's disease (HD) by measures of nutritional status, vital signs, and blood analysis.
II. Examine the feasibility and tolerability of TRE through measures of adherence rates and adverse events.
III. Analyze biomarker dynamics and explore whether TRE has effects on behavioral, cognitive, and motor function outcomes using standard HD clinical scales.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 CAP score greater than
- •Early manifest (stage I and II) HD as defined by a TFC greater than or equal to
- •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
- •Must fulfill both of the following criteria:
- •Have undergone genetic testing with a known CAG repeat greater than or equal to
- •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.
排除标准
- •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 marked cognitive impairment with a Montreal Cognitive Assessment (MoCA) Score less than or equal to
- •Have a presence of clinically significant psychosis and/or confusional states, in the opinion of the site Investigator.
- •Have clinically relevant hematologic, hepatic, cardiac, thyroid, or renal disease.
- •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.
结局指标
主要结局
Adherence to the TRE diet.
时间窗: 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.
次要结局
- Change from baseline in fat-free body mass.(Baseline, Week 13)
- Change from baseline in the daily eating period.(Baseline, Week 13)
- Change from baseline in plasma neurofilament light protein (NfL).(Baseline, Week 13)
- Change from baseline in plasma glial fibrillary acidic protein (GFAP).(Baseline, Week 13)
- Change from baseline in the Composite Unified Huntington's Disease Rating Scale (cUHDRS).(Baseline, Week 13)
研究者
Amie Hiller, MD
Principal Investigator
Oregon Health and Science University
研究点 (2)
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