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

Huntington Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05668520
• Other study ID #: 2-095-19
• Status: Enrolling by invitation
• Start date: October 1, 2022
• Est. completion date: October 2023

Study information

• Verified date: December 2022
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• stage 2 or 3 Huntington disease

Exclusion Criteria:

• unable to give consent

Related Conditions & MeSH terms

• Huntington Disease

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United Kingdom	Zosia Miedzybrodzka	Aberdeen	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfactory completion of body composition	measurement of body composition using hand-held body fat monitor	assessed at study visit for each participant
Primary	measurement of resting metabolic rate	measurement of Resting Metabolic Rate (RMR) using a ventilated hood system	assessed at study visit for each participant
Primary	measurement of body weight	body weight in kg	assessed at study visit for each participant
Primary	measurement of height	height in metres	assessed at study visit for each participant
Primary	completion of measurement of waist, arm and calf circumference	measurement of waist circumference, mid upper arm and calf circumference using a tape measure	assessed at study visit for each participant
Primary	nutritional assessment	estimation of energy, protein, carbohydrate and fat intake using MNA and MUST questionnaires	assessed at study visit for each participant
Secondary	variability of measures to power future grant applications	Descriptive statistics of each measurement by group	at end of study