Clinical trial NCT05668520: A Pilot Study of Nutritional Status in Patients With Huntington's Disease
Official title: A Pilot Study of Nutritional Status in Patients With Huntington's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Huntington Disease
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: manifesting Huntington disease patients of North of Scotland Huntington's clinic

Brief summary: It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. Our long term goal is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. We want to know which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.

Detailed description: Huntington's disease (HD) is a complex autosomal dominant disorder of (generally) adult onset. The clinical features of HD are cognitive decline, psychiatric disturbance, personality change and movement disorder. Although by EU definition a rare disease, better management and establishment of clinics for care of HD around the world have led to recognition of that the condition is much more common than previously considered.

Grampian has one of the longest established clinics for managing HD worldwide, and we now care for more than 150 people at different stages in HD, making us one of the largest five specialist clinics in the UK. Members of our team have led the production of European guidelines for HD management, and within this project, we have highlighted the importance of nutrition in HD. Weight loss is well documented as a clinical feature of all stages of Huntington's disease (HD). However, its metabolic basis is poorly understood and appetite has not been formally studied in patients with the condition. Furthermore, the composition of weight loss - muscle or fat has been little studied and modern nutrition assessment tools have not been applied in this cohort. It is known that weight loss is a poor prognostic marker in HD, but it is not known which dietary interventions are optimal at different stages of the disease. Current guidelines for HD treatment are informed only by studies in people with other causes of weight loss. The long term goal of this study is to create the evidence base for improved nutritional management in HD. This study will pilot the tools to inform the development of clinical trials protocols. The aim is to identify which measures can be used by patients manifesting obvious clinical features of HD, and which are most helpful in detecting clinically meaningful changes in nutrition status.

Eligibility criteria: Inclusion Criteria:

* stage 2 or 3 Huntington disease

Exclusion Criteria:

* unable to give consent

Primary outcomes:
measure: satisfactory completion of body composition
timeFrame: assessed at study visit for each participant
measure: measurement of resting metabolic rate
timeFrame: assessed at study visit for each participant
measure: measurement of body weight
timeFrame: assessed at study visit for each participant
measure: measurement of height
timeFrame: assessed at study visit for each participant
measure: completion of measurement of waist, arm and calf circumference
timeFrame: assessed at study visit for each participant
measure: nutritional assessment
timeFrame: assessed at study visit for each participant
Secondary outcomes:
measure: variability of measures to power future grant applications
timeFrame: at end of study
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Zosia Miedzybrodzka
state: Scotland
Study officials:
References: