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A Pilot Study of Nutritional Status in Patients With Huntington's Disease

NCT ID: NCT05668520

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Huntington Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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weight stable

stage 2 and 3 as defined by the UHDRS Total Functional Capacity score will be recruited. Ten will have reported at least 5% weight loss in a 12-month period,

Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system

Intervention Type DIAGNOSTIC_TEST

Consent Paperwork

* Nutritional assessment using MNA and MUST questionnaires
* 24-hour dietary recall assessment Body weight, height, waist circumference, mid upper arm and calf circumference

weight loss

stage 2 and 3 as defined by the UHDRS Total Functional Capacity score will be recruited. Ten will have reported at least 5% weight loss in a 12-month period,

Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system

Intervention Type DIAGNOSTIC_TEST

Consent Paperwork

* Nutritional assessment using MNA and MUST questionnaires
* 24-hour dietary recall assessment Body weight, height, waist circumference, mid upper arm and calf circumference

Interventions

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Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system

Consent Paperwork

* Nutritional assessment using MNA and MUST questionnaires
* 24-hour dietary recall assessment Body weight, height, waist circumference, mid upper arm and calf circumference

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Nutritional assessment

Eligibility Criteria

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Inclusion Criteria

* stage 2 or 3 Huntington disease

Exclusion Criteria

* unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Zosia Miedzybrodzka

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zosia Miedzybrodzka

Aberdeen, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2-095-19

Identifier Type: -

Identifier Source: org_study_id