Huntington DiseaseNCT05668520
A Pilot Study of Nutritional Status in Patients With Huntington's Disease
An observational study of Huntington Disease, run by University of Aberdeen at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: manifesting Huntington disease patients of North of Scotland Huntington's clinic
Who may be able to join
- stage 2 or 3 Huntington disease
Who cannot join
- unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Huntington Disease
- Being tested
- Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood systemDiagnostic test
Also called Nutritional assessment
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
| Study group | Role | What they receive |
|---|---|---|
| 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, Receives: Diagnostic Test: Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system | |
| 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, Receives: Diagnostic Test: Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood system |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfactory completion of body composition
measurement of body composition using hand-held body fat monitor
Measured: assessed at study visit for each participant
measurement of resting metabolic rate
measurement of Resting Metabolic Rate (RMR) using a ventilated hood system
Measured: assessed at study visit for each participant
measurement of body weight
body weight in kg
Measured: assessed at study visit for each participant
measurement of height
height in metres
Measured: 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
Measured: assessed at study visit for each participant
nutritional assessment
estimation of energy, protein, carbohydrate and fat intake using MNA and MUST questionnaires
Measured: assessed at study visit for each participant
Secondary outcomes (1)
variability of measures to power future grant applications
Descriptive statistics of each measurement by group
Measured: at end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start1 Oct 2022
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zosia Miedzybrodzka, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668520
- Sponsor's protocol ID
- 2-095-19
- Status last verified
- Dec 2022
- First submitted
- 30 Sep 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: de-identified data sharing would be considered on request but would require additional permissions
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Nutritional Status in Patients With Huntington's Disease
- ClinicalTrials.gov ID
- NCT05668520
- Acronym / sponsor ID
- 2-095-19
- Conditions
- Huntington Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weight stable | – | Diagnostic Test: Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood systemstage 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 | – | Diagnostic Test: Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood systemstage 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, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- manifesting Huntington disease patients of North of Scotland Huntington's clinic
Key inclusion criteria (1 listed)
- stage 2 or 3 Huntington disease
Key exclusion criteria (1 listed)
- unable to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body composition using a hand-held body fat monitor • Resting Metabolic Rate (RMR) using a ventilated hood systemAlso: Nutritional assessmentConsent Paperwork * Nutritional assessment using MNA and MUST questionnaires * 24-hour dietary recall assessment Body weight, height, waist circumference, mid upper arm and calf circumference | Diagnostic test | weight loss, weight stable |
Primary outcome
satisfactory completion of body composition
Time frame: assessed at study visit for each participant
measurement of body composition using hand-held body fat monitor
measurement of resting metabolic rate
Time frame: assessed at study visit for each participant
measurement of Resting Metabolic Rate (RMR) using a ventilated hood system
measurement of body weight
Time frame: assessed at study visit for each participant
body weight in kg
measurement of height
Time frame: assessed at study visit for each participant
height in metres
completion of measurement of waist, arm and calf circumference
Time frame: assessed at study visit for each participant
measurement of waist circumference, mid upper arm and calf circumference using a tape measure
nutritional assessment
Time frame: assessed at study visit for each participant
estimation of energy, protein, carbohydrate and fat intake using MNA and MUST questionnaires
1 secondary outcome
variability of measures to power future grant applications
Time frame: at end of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: Undecided. de-identified data sharing would be considered on request but would require additional permissions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Huntington Disease, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
satisfactory completion of body composition (time frame: assessed at study visit for each participant). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.