Evaluation of a Diet in Patients With Senile Dementia

NCT ID: NCT01192529

Last Updated: 2012-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alzheimer's Disease Parkinson's Disease Senile Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental Group

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

Group Type EXPERIMENTAL

Supressi. T-Diet plus Range

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

High Protein. T-Diet plus Range

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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VEG001 VEG002

Eligibility Criteria

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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.
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vegenat, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio J Pérez de la Cruz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Ángel Gil Hernández, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biochemistry and Molecular Biology II. University of Granada

Adrián Arés Luque, MD

Role: PRINCIPAL_INVESTIGATOR

Neurological Unit, Complejo Asistencial de León

Locations

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

Granada, Granada, Spain

Site Status RECRUITING

Department of Biochemistry and Molecular Biology II. University of Granada

Granada, Granada, Spain

Site Status RECRUITING

Neurological Unit, Complejo Asistencial de León

León, León, Spain

Site Status NOT_YET_RECRUITING

Countries

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Spain

Central Contacts

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Ángel Gil Hernández, PhD

Role: CONTACT

+34 695 466 922

Antonio J Pérez de la Cruz, MD PhD

Role: CONTACT

+34 639 236 825

Facility Contacts

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Antonio J Pérez de la Cruz, MD, PhD

Role: primary

+ 34 639 236 825

Ángel Gil Hernández, PhD

Role: primary

+34 695 466 922

Adrián Arés Luque, MD

Role: primary

+34 609 022 840

Other Identifiers

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SUPRESSI2010-PROYECTO CDTI

Identifier Type: OTHER

Identifier Source: secondary_id

VEGENAT-SUPR

Identifier Type: -

Identifier Source: org_study_id

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