Evaluation of a Diet in Patients With Senile Dementia

NCT01192529 | Unknown

• 2 other identifiers: VEGENAT-SUPRSUPRESSI2010-PROYECTO CDTI
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Senile; Dementia; Neurodegenerative; Supressi; Specific diet; Cognitive Status; Memory; Malnutrition; Parkinson; Alzheimer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Biochemical parameters measure

  8 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Dietary Supplement: Supressi. T-Diet plus Range

Control Group

ACTIVE COMPARATOR

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

Dietary Supplement: High Protein. T-Diet plus Range

Interventions

Supressi. T-Diet plus Range DIETARY_SUPPLEMENT

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.

Also known as: VEG001

Experimental Group

High Protein. T-Diet plus Range DIETARY_SUPPLEMENT

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.

Also known as: VEG002

Control Group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vegenat, S.A.: lead

Study Sites (3)

Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves

Granada, Granada, 18014, Spain

RECRUITING

Department of Biochemistry and Molecular Biology II. University of Granada

Granada, Granada, 18100, Spain

RECRUITING

Neurological Unit, Complejo Asistencial de León

León, León, 24071, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease; Dementia; Malnutrition

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Antonio J Pérez de la Cruz, MD PhD

  Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves

  PRINCIPAL INVESTIGATOR

• Ángel Gil Hernández, PhD

  Department of Biochemistry and Molecular Biology II. University of Granada

  PRINCIPAL INVESTIGATOR

• Adrián Arés Luque, MD

  Neurological Unit, Complejo Asistencial de León

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ángel Gil Hernández, PhD

CONTACT

+34 695 466 922; agil@ugr.es

Antonio J Pérez de la Cruz, MD PhD

CONTACT

+34 639 236 825

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 22, 2012

Record last verified: 2011-02

Locations

ES (3)