Evaluation of a Diet in Patients With Senile Dementia (SUPRESSI)

Vegenat

Status: Unknown

Conditions: Senile Dementia; Alzheimer's Disease; Parkinson's Disease

Treatments: Dietary Supplement: High Protein. T-Diet plus Range; Dietary Supplement: Supressi. T-Diet plus Range

Study type: Interventional

Funder types: Industry

Identifiers

NCT01192529

VEGENAT-SUPR

SUPRESSI2010-PROYECTO CDTI (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups

Experimental Group

Experimental group

Description:

In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement

Treatment:

Dietary Supplement: Supressi. T-Diet plus Range

Control Group

Active Comparator group

Description:

In addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product

Treatment:

Dietary Supplement: High Protein. T-Diet plus Range