Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05250323 |
| Other study ID # |
CEIM-2429 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 14, 2021 |
| Est. completion date |
June 23, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Hospital Universitario de Burgos |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
