A Pilot Study of Nutritional Status in Patients With Huntington's Disease
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2023
CompletedDecember 29, 2022
December 1, 2022
1 year
September 30, 2022
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (6)
satisfactory completion of body composition
measurement of body composition using hand-held body fat monitor
assessed at study visit for each participant
measurement of resting metabolic rate
measurement of Resting Metabolic Rate (RMR) using a ventilated hood system
assessed at study visit for each participant
measurement of body weight
body weight in kg
assessed at study visit for each participant
measurement of height
height in metres
assessed at study visit for each participant
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
nutritional assessment
estimation of energy, protein, carbohydrate and fat intake using MNA and MUST questionnaires
assessed at study visit for each participant
Secondary Outcomes (1)
variability of measures to power future grant applications
at end of study
Study Arms (2)
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,
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,
Interventions
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
Eligibility Criteria
manifesting Huntington disease patients of North of Scotland Huntington's clinic
You may qualify if:
- stage 2 or 3 Huntington disease
You may not qualify if:
- unable to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zosia Miedzybrodzka
Aberdeen, Scotland, AB25 2ZA, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 30, 2022
First Posted
December 29, 2022
Study Start
October 1, 2022
Primary Completion
October 1, 2023
Study Completion
October 1, 2023
Last Updated
December 29, 2022
Record last verified: 2022-12