Evaluation of a Diet in Patients With Senile Dementia

NCT01192529 — Not applicable, Unknown, 184 participants, Vegenat, S.A.

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Clinical Evaluation of an Specific Diet for People With Dementia Disease

Registry	NCT01192529, acronym SUPRESSI
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	184 (Estimated)
Sponsor	Vegenat, S.A. (Industry)
Conditions	Alzheimer's Disease, Parkinson's Disease, Senile Dementia
Interventions	Supressi. T-Diet plus Range, High Protein. T-Diet plus Range (Dietary supplement)
Dates	start 2010-10-01, primary completion 2012-09-01 (estimated), completion 2012-12-01 (estimated), first posted 2010-09-01, last updated 2012-06-22
Locations	3 sites in Spain

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Experimental Group	Experimental	Dietary Supplement: Supressi. T-Diet plus Range	In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement
Control Group	Active comparator	Dietary Supplement: High Protein. T-Diet plus Range	In addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product

Supressi. T-Diet plus Range (Dietary supplement), also known as VEG001: 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.
High Protein. T-Diet plus Range (Dietary supplement), also known as VEG002: 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.

+Outcome measures

Primary outcomes

Nutritional and cognitive status in elderly people [1 year]: 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.

Secondary outcomes

Biochemical parameters measure [8 months]: 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.

+Eligibility

Sex: All, ages: 70 Years to any

Inclusion Criteria:

* Patients over 70 years with neurologist or geriatrician dementia diagnosis (Alzheimer's disease, Parkinson's or mixed), with mild or moderate cognitive impairment degree (Between 24 and 14 MMSE).
* Patients with or at malnutrition risk (Mini Nutritional Assessment screening positive)

Exclusion Criteria:

* Patients with decompensated kidney failure, creatine and/or bilirubin greater than 2, uric acid higher than 8 mg/dl, and glomerular filtration under 60 ml/minute.
* Patients with Diabetes mellitus poorly controlled (Glycemia > 200 mg/dl)
* Patients with decompensated hypertension.
* Patients with pharmacological treatment or consuming supplements containing specific supplementation of experimental product (omega 3 and/or vitamins supplements).
* Post-stroke vascular dementias.
* Do not achieve any inclusion criteria.

+Locations (3)

Facility	City	Country	Status
Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves	Granada, Granada	Spain	Recruiting
Department of Biochemistry and Molecular Biology II. University of Granada	Granada, Granada	Spain	Recruiting
Neurological Unit, Complejo Asistencial de León	León, León	Spain	Not yet recruiting

+Investigators

Antonio J Pérez de la Cruz, MD PhD, Principal investigator, Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Ángel Gil Hernández, PhD, Principal investigator, Department of Biochemistry and Molecular Biology II. University of Granada
Adrián Arés Luque, MD, Principal investigator, Neurological Unit, Complejo Asistencial de León

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