Evaluation of a Diet in Patients With Senile Dementia
Information source: Vegenat, S.A.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer's Disease; Parkinson's Disease; Senile Dementia
Intervention: Supressi. T-Diet plus Range (Dietary Supplement); High Protein. T-Diet plus Range (Dietary Supplement)
Phase: N/A
Status: Recruiting
Sponsored by: Vegenat, S.A. Official(s) and/or principal investigator(s):
Antonio J Pérez de la Cruz, MD PhD, Principal Investigator, Affiliation: Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Ángel Gil Hernández, PhD, Principal Investigator, Affiliation: Department of Biochemistry and Molecular Biology II. University of Granada
Adrián Arés Luque, MD, Principal Investigator, Affiliation: Neurological Unit, Complejo Asistencial de León
Overall contact:
Ángel Gil Hernández, PhD, Phone: +34 695 466 922, Email: agil@ugr.es
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.
Clinical Details
Official title: Clinical Evaluation of an Specific Diet for People With Dementia Disease
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Primary outcome: Nutritional and cognitive status in elderly people
Secondary outcome: Biochemical parameters measure
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.
Eligibility
Minimum age: 70 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Ángel Gil Hernández, PhD, Phone: +34 695 466 922, Email: agil@ugr.es
Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves, Granada 18014, Spain; Recruiting
Antonio J Pérez de la Cruz, MD, PhD, Phone: + 34 639 236 825, Email: antonioj.perez.sspa@juntadeandalulcia.es
Antonio J Pérez de la Cruz, MD, PhD, Principal Investigator
Department of Biochemistry and Molecular Biology II. University of Granada, Granada 18100, Spain; Recruiting
Ángel Gil Hernández, PhD, Phone: +34 695 466 922, Email: agil@ugr.es
Ángel Gil Hernández, PhD, Principal Investigator
Neurological Unit, Complejo Asistencial de León, León 24071, Spain; Not yet recruiting
Adrián Arés Luque, MD, Phone: +34 609 022 840, Email: adrianares@telefonica.net
Adrián Arés Luque, MD, Principal Investigator
Additional Information
Starting date: October 2010
Last updated: June 21, 2012
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