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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


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
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