Alzheimer's DiseaseSUPRESSINCT01192529
Evaluation of a Diet in Patients With Senile Dementia
A study testing Supressi. T-Diet plus Range and High Protein. T-Diet plus Range in people with Alzheimer's Disease and Parkinson's Disease, run by Vegenat, S.A. at 3 sites in Spain.
Trial 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 more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Alzheimer's Disease, Parkinson's Disease, Senile Dementia
- What is being tested?
- Supressi. T-Diet plus Range and High Protein. T-Diet plus Range
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 3 sitesSpain
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Antonio J Pérez de la Cruz, MD PhD contact
Spain3 sites, 3 recruiting
- Recruiting
Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las Nieves
Granada, Granada, 18014
Antonio J Pérez de la Cruz, MD, PhD, + 34 639 236 825, antonioj.perez.sspa@juntadeandalulcia.es
Antonio J Pérez de la Cruz, MD, PhD
- Recruiting
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Granada, 18100
Ángel Gil Hernández, PhD, +34 695 466 922, agil@ugr.es
Ángel Gil Hernández, PhD
- Not yet recruiting
Neurological Unit, Complejo Asistencial de León
León, León, 24071
Adrián Arés Luque, MD, +34 609 022 840, adrianares@telefonica.net
Adrián Arés Luque, MD
About this study
Official title: 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.
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.
- Conditions
- Alzheimer's Disease, Parkinson's Disease, Senile Dementia
- Being tested
- Supressi. T-Diet plus Range, High Protein. T-Diet plus Range
- Keywords
- Senile, Dementia, Neurodegenerative, Supressi, Specific diet, Cognitive Status, Memory, Malnutrition, Parkinson, Alzheimer
- Medical subject headings
- Alzheimer Disease, Parkinson Disease, Dementia, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supressi. T-Diet plus RangeDietary supplement
Also called VEG001
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.
High Protein. T-Diet plus RangeDietary supplement
Also called VEG002
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement Receives: 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 Receives: Dietary Supplement: High Protein. T-Diet plus Range |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vegenat, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio J Pérez de la Cruz, MD PhD, Principal investigator, Clinical Nutrition and Dietetic Unit, University Hospital Virgen de las NievesÁngel Gil Hernández, PhD, Principal investigator, Department of Biochemistry and Molecular Biology II. University of GranadaAdrián Arés Luque, MD, Principal investigator, Neurological Unit, Complejo Asistencial de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192529
- Sponsor's protocol ID
- VEGENAT-SUPR
- Other IDs
- SUPRESSI2010-PROYECTO CDTI
- Acronym
- SUPRESSI
- Status last verified
- Feb 2011
- First submitted
- 30 Aug 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of an Specific Diet for People With Dementia Disease
- ClinicalTrials.gov ID
- NCT01192529
- Acronym / sponsor ID
- SUPRESSI / VEGENAT-SUPR
- Conditions
- Alzheimer's Disease, Parkinson's Disease, Senile Dementia
- Keywords
- Senile, Dementia, Neurodegenerative, Supressi, Specific diet, Cognitive Status, Memory, Malnutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Vegenat, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Dietary Supplement: Supressi. T-Diet plus RangeIn addition to their daily diet, patients of this group will receive 400 ml per day of "Supressi" nutritional supplement |
| Control Group | Active comparator | Dietary Supplement: High Protein. T-Diet plus RangeIn addition to their daily diet, patients of this group will receive 400 ml per day of "T-Diet plus High Protein" product |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supressi. T-Diet plus RangeAlso: VEG001Supressi 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. | Dietary supplement | Experimental Group |
| High Protein. T-Diet plus RangeAlso: VEG002T-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. | Dietary supplement | Control Group |
Primary outcome
Nutritional and cognitive status in elderly people
Time frame: 1 year
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 secondary outcome
Biochemical parameters measure
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio J Pérez de la Cruz, MD PhD contact
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supressi. T-Diet plus Range and High Protein. T-Diet plus Range in people with Alzheimer's Disease and Parkinson's Disease, run by Vegenat, S.A. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ángel Gil Hernández, PhD (+34 695 466 922, agil@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional and cognitive status in elderly people (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.