Evaluation of a Diet in Patients With Senile Dementia

Not Applicable

• Conditions: Alzheimer's Disease; Parkinson's Disease; Senile Dementia
• Interventions: Dietary Supplement: Supressi. T-Diet plus Range; Dietary Supplement: High Protein. T-Diet plus Range

• Registration Number: NCT01192529
• Lead Sponsor: Vegenat, S.A.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study First Posted: 2010-09-01
• Study Start: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	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	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves; 🇪🇸 Granada, Spain

Neurological Unit, Complejo Asistencial de León; 🇪🇸 León, Spain

Department of Biochemistry and Molecular Biology II. University of Granada; 🇪🇸 Granada, Spain