Huntington DiseaseBEHD-EMNCT05250323
Energy Balance in Huntington's Disease. A Multidisciplinary Study Approach for a Complex Problem (BEHD-EM)
An observational study of Huntington Disease, run by Hospital Universitario de Burgos at 1 site in Spain.
Trial summary
The study was conducted at the University Isabel I, Burgos in collaboration with the Hospital Universitario Burgos, Spain, through the creation of a multidisciplinary research team including graduates in physical activity and sports sciences, dietitians-nutritionists, neurologists and occupational therapists. 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?
- observational tests in face-to-face visit
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 14 May 2021to 23 Jun 2021
- 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
- Adult, Older adult
Study population: People with Huntington's disease and non-gene family relatives
Who may be able to join
- Older than 18 years-old
- Genetic confirmation of Huntington's disease
- Symptomatic (motor manifestations with a score greater than 4 on the Unified HD scale)
- Walk with minimal support
- Participate in Enroll study
- Non-gene carriers, family relatives
Who cannot join
- Sensory deficits or other systemic diseases which according to the Investigator judgment may interfere with the execution of the study
Trial locations and contacts
1 site in 1 country.
About this study
The study was conducted at the University Isabel I, Burgos in collaboration with the Hospital Universitario Burgos, Spain, through the creation of a multidisciplinary research team including graduates in physical activity and sports sciences, dietitians-nutritionists, neurologists and occupational therapists. To carry out this study: 1) the investigators used new technologies, specifically, small wearable or wearable devices available to the population. These devices measure their daily behaviour and estimate aspects such as energy expenditure, validated both in healthy participants and in participants with neurodegenerative diseases such as Parkinson's disease, but not in HD; 2) the investigators included a consecutive sample of patients with HD ; 3) the investigators performed the experimental study at the the laboratory for Exercise Physiology, Health and Quality of Life at the Isabel I University.
The hypothesis proposed by this study are the following: 1) Patients with HD who present an adequate energy balance caused by healthier lifestyles (active lifestyles and healthy eating) will present a better functional capacity, quality of life and therefore both less dependency; 2) HD patients with a balanced energy balance maintain adequate body composition (muscle, fat); 3) Adequate body composition is associated with better functional capacity in HD patients.
Read the detailed description
In the last decade, numerous studies have been published showing how epigenetic (environmental) factors can modify the clinical manifestations of diseases of genetic origin. Specifically, epidemiological studies have observed that physical exercise delays the onset and slows down the progression of neurodegenerative diseases (dementia, Parkinson's disease, HD), by producing, between the different mechanisms, greater plasticity of the different neuronal circuits. Another environmental factor such as nutrition has also been highlighted by numerous authors, highlighting the role of the Mediterranean diet in delaying the onset, especially in Parkinson's disease, as the phenolic components of olive oil produce an inhibition of the Pathological aggregation of modified alpha synuclein. On the contrary, it has been seen that an energy deficit at the cellular level accelerates the neurodegeneration process, shortening survival in different animal models.
To maintain an adequate energy balance, it is required that the energy expenditure produced by physical activity (GAF), plus the expenditure produced by the maintenance of the different organs: energy expenditure at rest (GAR) and thermogenesis, is similar to the input of energy produced by the oxidation of macronutrients from food intake. In HD, it is believed that this energy balance is not adequate, either due to the decrease in food intake (very frequent when there are swallowing problems), and the decrease in physical activity produced by alterations in mobility, or by structural damage (hypothalamic, mitochondrial) produced by the neurodegeneration process per se. When the energy balance is negative (energy expenditure> caloric intake), due to a decrease in intake or due to sustained involuntary physical activity (chorea), it can lead to the use of other energy substrates such as adipose tissue and muscle, triggering sarcopenia, cachexia, and ultimately, accelerating the neurodegeneration process. Weight loss and a low body mass index (BMI) in patients with neurodegenerative diseases lead to a greater development of neurological symptoms, while a high food intake has been associated with a more rapid progression in the symptoms of these patients. For all these reasons, it seems that nutrition plays a determining role, the dietary and nutritional analysis being fundamental.
To date, there are very few studies on energy balance in neurodegenerative diseases, addressing it from a comprehensive point of view and analysing each of its contributing components (energy expenditure-caloric intake). A better knowledge of the energy balance in HD may lead to the development of non-pharmacological, easily accessible and cost-effective therapeutic strategies such as lifestyle modifications, through adequate physical activity and nutritional intake.
- Conditions
- Huntington Disease
- Being tested
- observational tests in face-to-face visit
- Keywords
- energy expenditure, physical activity, nutrition, wereables, daily life activity
- Medical subject headings
- Huntington Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational tests in face-to-face visitOther
All necessary evaluations will be carried out for data collection. Also, that same day, the investigators will give the device to participants for the 7-day home assessment
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with genetic confirmation of Huntington's disease, symptomatic (motor manifestations with a score greater than 4 on the Unified HD scale), who can walk with minimal support, without sensory deficits or other systemic diseases an Investigator judgment that may interfere with the execution of the study, coming from the Enroll study. Receives: Other: observational tests in face-to-face visit | |
| Control | Age, gender-matched non-gene carriers family relatives Receives: Other: observational tests in face-to-face visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of energy expenditure at rest
by indirect calorimetry recording respiratory exchange (Medisoft Ergocard, Medisoft Group, Sorinnes, Belgium)
Measured: 10 minutes
Measurement of energy expenditure due to physical activity
using a wearable device (Fitbit Charge), which allows quantification in a valid and reliable way, in patients with HD
Measured: 45 minutes
Determination of caloric intake
by registering eating habits (SUN food frequency questionnaire and a 3-day food diary)
Measured: 30 minutes
Bone densitometry (DXA)
Determination of body composition
Measured: 10 minutes
Secondary outcomes (3)
Validation of the wearable comparing the results with a gold standard
using indirect calorimetry and accelerometery (ActiGraph wGT3X-BT) during activities of various kinds and intensity (walking at different speeds and slopes) on a treadmill (h / p / cosmos pulsar, h / p / cosmos sports and medical GMBH, Nussdorf-Traunstein, Germany) and activities of daily living together with pedalling on a cycle ergometer
Measured: 45 minutes
Determination of the incidence of thermogenesis on energy expenditure and on the appearance of fatigue
by recording the central and peripheral temperature (VitalSense, Phillips Respironics, Bend, OR, USA).
Measured: 2 hours
Determination of lifestyle and weekly energy expenditure
for this the participants will wear the device for 7 consecutive days
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start14 May 2021
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Burgos
- Sponsor type
- University, hospital or other
- Collaborators
- La Caixa Foundation, Universidad Isabel I
- Responsible party
- Principal investigator, Esther Cubo, Hospital Universitario de Burgos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250323
- Sponsor's protocol ID
- CEIM-2429
- Acronym
- BEHD-EM
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Energy Balance in Huntington's Disease. A Multidisciplinary Study Approach for a Complex Problem (BEHD-EM)
- ClinicalTrials.gov ID
- NCT05250323
- Acronym / sponsor ID
- BEHD-EM / CEIM-2429
- Conditions
- Huntington Disease
- Keywords
- energy expenditure, physical activity, nutrition, wereables, daily life activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Universitario de BurgosUniversity, hospital or other
- Collaborators
- La Caixa Foundation, Universidad Isabel I
- Study start
- 14 May 2021 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 22 Feb 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.
The study was conducted at the University Isabel I, Burgos in collaboration with the Hospital Universitario Burgos, Spain, through the creation of a multidisciplinary research team including graduates in physical activity and sports sciences, dietitians-nutritionists, neurologists and occupational therapists. To carry out this study: 1) the investigators used new technologies, specifically, small wearable or wearable devices available to the population. These devices measure their daily behaviour and estimate aspects such as energy expenditure, validated both in healthy participants and in participants with neurodegenerative diseases such as Parkinson's disease, but not in HD; 2) the investigators included a consecutive sample of patients with HD ; 3) the investigators performed the experimental study at the the laboratory for Exercise Physiology, Health and Quality of Life at the Isabel I University.
The hypothesis proposed by this study are the following: 1) Patients with HD who present an adequate energy balance caused by healthier lifestyles (active lifestyles and healthy eating) will present a better functional capacity, quality of life and therefore both less dependency; 2) HD patients with a balanced energy balance maintain adequate body composition (muscle, fat); 3) Adequate body composition is associated with better functional capacity in HD patients.
Detailed description
In the last decade, numerous studies have been published showing how epigenetic (environmental) factors can modify the clinical manifestations of diseases of genetic origin. Specifically, epidemiological studies have observed that physical exercise delays the onset and slows down the progression of neurodegenerative diseases (dementia, Parkinson's disease, HD), by producing, between the different mechanisms, greater plasticity of the different neuronal circuits. Another environmental factor such as nutrition has also been highlighted by numerous authors, highlighting the role of the Mediterranean diet in delaying the onset, especially in Parkinson's disease, as the phenolic components of olive oil produce an inhibition of the Pathological aggregation of modified alpha synuclein. On the contrary, it has been seen that an energy deficit at the cellular level accelerates the neurodegeneration process, shortening survival in different animal models.
To maintain an adequate energy balance, it is required that the energy expenditure produced by physical activity (GAF), plus the expenditure produced by the maintenance of the different organs: energy expenditure at rest (GAR) and thermogenesis, is similar to the input of energy produced by the oxidation of macronutrients from food intake. In HD, it is believed that this energy balance is not adequate, either due to the decrease in food intake (very frequent when there are swallowing problems), and the decrease in physical activity produced by alterations in mobility, or by structural damage (hypothalamic, mitochondrial) produced by the neurodegeneration process per se. When the energy balance is negative (energy expenditure> caloric intake), due to a decrease in intake or due to sustained involuntary physical activity (chorea), it can lead to the use of other energy substrates such as adipose tissue and muscle, triggering sarcopenia, cachexia, and ultimately, accelerating the neurodegeneration process. Weight loss and a low body mass index (BMI) in patients with neurodegenerative diseases lead to a greater development of neurological symptoms, while a high food intake has been associated with a more rapid progression in the symptoms of these patients. For all these reasons, it seems that nutrition plays a determining role, the dietary and nutritional analysis being fundamental.
To date, there are very few studies on energy balance in neurodegenerative diseases, addressing it from a comprehensive point of view and analysing each of its contributing components (energy expenditure-caloric intake). A better knowledge of the energy balance in HD may lead to the development of non-pharmacological, easily accessible and cost-effective therapeutic strategies such as lifestyle modifications, through adequate physical activity and nutritional intake.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Other: observational tests in face-to-face visitPatients with genetic confirmation of Huntington's disease, symptomatic (motor manifestations with a score greater than 4 on the Unified HD scale), who can walk with minimal support, without sensory deficits or other systemic diseases an Investigator judgment that may interfere with the execution of the study, coming from the Enroll study. |
| Control | – | Other: observational tests in face-to-face visitAge, gender-matched non-gene carriers family relatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People with Huntington's disease and non-gene family relatives
Key inclusion criteria (6 listed)
- Older than 18 years-old
- Genetic confirmation of Huntington's disease
- Symptomatic (motor manifestations with a score greater than 4 on the Unified HD scale)
- Walk with minimal support
- Participate in Enroll study
Key exclusion criteria (1 listed)
- Sensory deficits or other systemic diseases which according to the Investigator judgment may interfere with the execution of the study
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 |
|---|---|---|
| observational tests in face-to-face visitAll necessary evaluations will be carried out for data collection. Also, that same day, the investigators will give the device to participants for the 7-day home assessment | Other | Case, Control |
Primary outcome
Measurement of energy expenditure at rest
Time frame: 10 minutes
by indirect calorimetry recording respiratory exchange (Medisoft Ergocard, Medisoft Group, Sorinnes, Belgium)
Measurement of energy expenditure due to physical activity
Time frame: 45 minutes
using a wearable device (Fitbit Charge), which allows quantification in a valid and reliable way, in patients with HD
Determination of caloric intake
Time frame: 30 minutes
by registering eating habits (SUN food frequency questionnaire and a 3-day food diary)
Bone densitometry (DXA)
Time frame: 10 minutes
Determination of body composition
3 secondary outcomes
Validation of the wearable comparing the results with a gold standard
Time frame: 45 minutes
Determination of the incidence of thermogenesis on energy expenditure and on the appearance of fatigue
Time frame: 2 hours
Determination of lifestyle and weekly energy expenditure
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Individual participant dataSharing planned: No
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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 Hospital Universitario de Burgos at 1 site in Spain.
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 6 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: finished, as of the sponsor's last update on 22 Feb 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of energy expenditure at rest (time frame: 10 minutes). The study lists 4 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 22 Feb 2022.