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

Clinical Evaluation of an Specific Diet for People With Dementia Disease

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease; Alzheimer's Disease; Senile Dementia
• Intervention / Treatment: Dietary supplement: Supressi. T-Diet plus Range; Dietary supplement: High Protein. T-Diet plus Range

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 Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ángel Gil Hernández, PhD; Phone Number: +34 695 466 922; Email: agil@ugr.es
• Study Contact Backup: Name: Antonio J Pérez de la Cruz, MD PhD; Phone Number: +34 639 236 825

Study Locations

• Spain
  • Granada, Spain, 18014
    • Recruiting
    • Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
    • Contact: Antonio J Pérez de la Cruz, MD, PhD; Phone Number: + 34 639 236 825; Email: antonioj.perez.sspa@juntadeandalulcia.es
    • Principal Investigator: Antonio J Pérez de la Cruz, MD, PhD
  • Granada, Spain, 18100
    • Recruiting
    • Department of Biochemistry and Molecular Biology II. University of Granada
    • Contact: Ángel Gil Hernández, PhD; Phone Number: +34 695 466 922; Email: agil@ugr.es
    • Principal Investigator: Ángel Gil Hernández, PhD
  • León, Spain, 24071
    • Not yet recruiting
    • Neurological Unit, Complejo Asistencial de León
    • Contact: Adrián Arés Luque, MD; Phone Number: +34 609 022 840; Email: adrianares@telefonica.net
    • Principal Investigator: Adrián Arés Luque, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; 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; 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.; Other Names: VEG001
Active Comparator: Control Group; 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; 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.; Other Names: VEG002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vegenat, S.A.
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): September 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 30, 2010
• First Submitted That Met QC Criteria: August 30, 2010
• First Posted (Estimate): September 1, 2010

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Parkinson; Dementia; Alzheimer; Memory; Malnutrition; Neurodegenerative; Senile; Supressi; Specific diet; Cognitive Status
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Tauopathies; Parkinson Disease; Dementia; Alzheimer Disease; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Phentermine
• Other Study ID Numbers: VEGENAT-SUPR; SUPRESSI2010-PROYECTO CDTI (Other Identifier: VEGENAT, S.A.)