Evaluation of a Diet in Patients With Senile Dementia

Parkinson's Disease Clinical Trial

— SUPRESSI  

Official title:

Clinical Evaluation of an Specific Diet for People With Dementia Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01192529
• Other study ID #: VEGENAT-SUPR
• Secondary ID: SUPRESSI2010-PRO
• Status: Recruiting
• Phase: N/A
• First received: August 30, 2010
• Last updated: June 21, 2012
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2011
• Source: Vegenat, S.A.
• Contact: Ángel Gil Hernández, PhD
• Phone: +34 695 466 922
• Email: agil[@]ugr.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia
• Parkinson Disease
• Parkinson's Disease
• Senile Dementia

Intervention

Dietary Supplement:
• Supressi. T-Diet plus Range
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
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.

Locations

Country	Name	City	State
Spain	Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves	Granada
Spain	Department of Biochemistry and Molecular Biology II. University of Granada	Granada
Spain	Neurological Unit, Complejo Asistencial de León	León

Sponsors (1)

Lead Sponsor	Collaborator
Vegenat, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	8 months	No