CClinicalTrials.gg
Status unknownNCT01192529SUPRESSIUpdated Jun 22, 2012

Evaluation of a Diet in Patients With Senile Dementia

An interventional study of Supressi. T-Diet plus Range and High Protein. T-Diet plus Range in Alzheimer's Disease, Parkinson's Disease and Senile Dementia, sponsored by Vegenat, S.A.. Status unknown at 3 sites in Spain. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2012-06-22.

Sponsored by Vegenat, S.A. · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Feb 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
184
Allocation
Randomized
Ages
70 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer's Disease
  • Parkinson's Disease
  • Senile Dementia

Keywords

  • Senile
  • Dementia
  • Neurodegenerative
  • Supressi
  • Specific diet
  • Cognitive Status
  • Memory
  • Malnutrition
  • Parkinson
  • Alzheimer
03

In context

Parkinson Disease

4,484 studies on the registry are indexed under Parkinson Disease; 1,081 are open to participants now.

This study's planned enrollment of 184 is above the median of 40 across 3,293 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Vegenat, S.A. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
184 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementSupressi. 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.

    Also known as: VEG001

  • Dietary supplementHigh 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.

    Also known as: VEG002

06

What researchers measure

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.

    Time frame: 1 year

Secondary outcomes

  1. 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.

    Time frame: 8 months

07

Study locations

2 of 3 sites recruiting
  • Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
    Granada, 18014, Spain
    Recruiting
  • Department of Biochemistry and Molecular Biology II. University of Granada
    Granada, 18100, Spain
    • Ángel Gil Hernández, PhD · Contact · agil@ugr.es · +34 695 466 922
    • Ángel Gil Hernández, PhD · Principal investigator
    Recruiting
  • Neurological Unit, Complejo Asistencial de León
    León, 24071, Spain
    • Adrián Arés Luque, MD · Contact · adrianares@telefonica.net · +34 609 022 840
    • Adrián Arés Luque, MD · Principal investigator
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01192529
Lead sponsor
Vegenat, S.A.
Responsible party
Sponsor
First posted
Sep 1, 2010
Start date
Oct 2010
Primary completion
Sep 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Jun 22, 2012

Study contacts

Ángel Gil Hernández, PhD
Contact
agil@ugr.es
+34 695 466 922
Antonio J Pérez de la Cruz, MD PhD
Contact
+34 639 236 825
Antonio J Pérez de la Cruz, MD PhD
principal investigator · Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Ángel Gil Hernández, PhD
principal investigator · Department of Biochemistry and Molecular Biology II. University of Granada
Adrián Arés Luque, MD
principal investigator · Neurological Unit, Complejo Asistencial de León

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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