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| ID | Type | Description | Link |
|---|---|---|---|
| SUPRESSI2010-PROYECTO CDTI | Other Identifier | VEGENAT, S.A. |
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The most common symptoms associated to senile dementia disease are confusion about schedules, hyperactivity... In this sense, these patients have frequently poor nutrition, resulting in malnutrition problems or malnutrition high risk.
The purpose of this study is to assess if the daily intake of a specific nutritional supplement versus a non specific supplement one is related to malnutrition or malnutrition risk reduction and contributes to an improvement in cognitive and functional parameters in patients with senile dementia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement |
|
| Control Group | Active Comparator | In addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supressi. T-Diet plus Range | Dietary Supplement | Supressi is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patients with neurodegenerative diseases and related malnutrition. Experimental group patients will receive, 2 packs per day (Tetra brik aseptic)of 200 ml for 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional and cognitive status in elderly people | The evaluation include: Nutritional evaluation, Improvement of Anthropometric and Biochemical parameters evaluation in relation to patient malnutrition, Patient's cognitive status evaluation (Folstein's MMSE and GDS scale), Functional and psychopathological aspects evaluation (blessed Scale), Global Impresion of Change Evaluation(CIBIC plus Scale), Quality of life evaluation (Short Form 36 questionaire), Memory Evaluation (Rey Auditory Learning Test), Appearance of gastrointestinal events evaluation, Diet and Intake acceptance evaluation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical parameters measure | Fatty acid profile of plasma and erythrocytes, plasma levels of some proinflammatory cytokines and b-amyloid, genotyped, oxidative stress determination, total proteins determination, total lymphocytes, albumin, pre-albumin, transferrine, Reactive C protein (RCP), homocystein, total cholesterol, plasma level of glucose, Homeostasis Model Assessment and Renal function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ángel Gil Hernández, PhD | Contact | +34 695 466 922 | agil@ugr.es | |
| Antonio J Pérez de la Cruz, MD PhD | Contact | +34 639 236 825 |
| Name | Affiliation | Role |
|---|---|---|
| Antonio J Pérez de la Cruz, MD PhD | Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves | Principal Investigator |
| Ángel Gil Hernández, PhD | Department of Biochemistry and Molecular Biology II. University of Granada |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves | Recruiting | Granada | Granada | 18014 | Spain |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D010300 | Parkinson Disease |
| D003704 | Dementia |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| High Protein. T-Diet plus Range | Dietary Supplement | T-Diet plus High Protein is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patient with related malnutrition and with increased protein requirements. |
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| 8 months |
| Adrián Arés Luque, MD | Neurological Unit, Complejo Asistencial de León | Principal Investigator |
| Department of Biochemistry and Molecular Biology II. University of Granada | Recruiting | Granada | Granada | 18100 | Spain |
|
| Neurological Unit, Complejo Asistencial de León | Not yet recruiting | León | León | 24071 | Spain |
|
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |