Severe Insufficient NutritionSTDUGRNCT01303289
Clinical Evaluation of a Normoproteic Diet
A study testing T-Diet plus Standard and Jevity in people with Severe Insufficient Nutrition, run by Vegenat, S.A. at 1 site in Spain.
Trial summary
The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people. For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Insufficient Nutrition
- What is being tested?
- T-Diet plus Standard and Jevity
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2006to Dec 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 65 years old, of both sex, receiving total enteral nutrition by tube.
- Admitted to medically supervised institutions (homes, health centers).
- Requirement for total enteral nutrition standard, at least 3 months.
- Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves).
Who cannot join
- Patients who receive drugs with lipid composition.
- Unstable clinical situation.
- Patients with terminal illness.
- Refusal or physical or mental inability to cooperate in the study.
- Participating in another study.
- Other causes: social causes, humanitarian, non-cooperation, etc..
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Biochemistry and Molecular Biology II. University of Granada
Granada, Granada, 18100
About this study
Official title: Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment
The main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people.
For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).
Read the detailed description
The project includes:
- Product tolerance study: gastrointestinal and metabolic complications related to the product administration.
- The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry).
- The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.
- Conditions
- Severe Insufficient Nutrition
- Being tested
- T-Diet plus Standard, Jevity
- Keywords
- Total Enteral Nutrition, Severe insufficient nutrition, T-Diet plus Standard, Lipidic profile, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Diet plus StandardDietary supplement
Also called TDP STD
T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
JevityDietary supplement
Also called JEV ABBT
JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The group 1 will receive the experimental product T-Diet plus Standard for 3 months. Receives: Dietary Supplement: T-Diet plus Standard |
| Group 2 | Active comparator | The group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months. Receives: Dietary Supplement: Jevity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status evaluation
Clinical evaluation of a comercial product: T-Diet Plus (normoproteic and specific diet), when is used for total enteral nutrition in geriatric people.
Measured: 6 months
Secondary outcomes (1)
Specific parameters measure
- Confirm gastrointestinal and metabolic tolerance of the product.
- Consider the influence of the diet received on quality of life related to health.
- Study the changes in the nutritional status of elderly patients
- Assess changes in the lipid profile of patients
- Compare the evolution in blood levels of metabolic syndrome indicator parameters and other related to cardiovascular morbidity.
- Assess changes in the antioxidant defense system.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startFeb 2006
- Primary completionJan 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Insufficient NutritionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vegenat, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ángel Gil, PhD, Principal investigator, Departament of Biochemistry and Molecular Biology II. University of Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303289
- Sponsor's protocol ID
- VEGENAT-TDP STD UGR
- Other IDs
- TDP STANDARD 2006
- Acronym
- STDUGR
- Status last verified
- Feb 2011
- First submitted
- 17 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Normoproteic Diet With Ultra High Temperature Treatment
- ClinicalTrials.gov ID
- NCT01303289
- Acronym / sponsor ID
- STDUGR / VEGENAT-TDP STD UGR
- Conditions
- Severe Insufficient Nutrition
- Keywords
- Total Enteral Nutrition, Severe insufficient nutrition, T-Diet plus Standard, Lipidic profile, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vegenat, S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 24 Feb 2011 (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 main objective of this trial is the clinical evaluation of a normoproteic diet, when this diet is used for total enteral nutrition in geriatric people.
For 3 months,all the participants in the study will receive only tube feeding: The experimental group will receive the commercial preparation to evaluate (T-Diet Plus ®, Vegenat SA) and the control group will receive a standard diet (Jevity ®, Abbott Laboratories).
Detailed description
The project includes:
- Product tolerance study: gastrointestinal and metabolic complications related to the product administration.
- The monitoring of the intervention, and clinical and nutritional evaluation of the participants, including anthropometry, quality of life related to the health and clinical and nutritional status analytical evaluation (hematology and biochemistry).
- The determination of the major biochemical variables related to the lipid profile and assessment of the antioxidant defense system, and also certain markers of metabolic syndrome and associated cardiovascular risk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: T-Diet plus StandardThe group 1 will receive the experimental product T-Diet plus Standard for 3 months. |
| Group 2 | Active comparator | Dietary Supplement: JevityThe group 2 will receive the control product Jevity (Abbott Laboratories) for 3 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients over 65 years old, of both sex, receiving total enteral nutrition by tube.
- Admitted to medically supervised institutions (homes, health centers).
- Requirement for total enteral nutrition standard, at least 3 months.
- Acceptance volunteer to participate in the study by signing the written informed consent (approved by the Ethics Committee of University Hospital Virgen de las Nieves).
Key exclusion criteria (6 listed)
- Patients who receive drugs with lipid composition.
- Unstable clinical situation.
- Patients with terminal illness.
- Refusal or physical or mental inability to cooperate in the study.
- Participating in another study.
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 |
|---|---|---|
| T-Diet plus StandardAlso: TDP STDT-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition. | Dietary supplement | Group 1 |
| JevityAlso: JEV ABBTJEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders. | Dietary supplement | Group 2 |
Primary outcome
Nutritional status evaluation
Time frame: 6 months
Clinical evaluation of a comercial product: T-Diet Plus (normoproteic and specific diet), when is used for total enteral nutrition in geriatric people.
1 secondary outcome
Specific parameters measure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
Related trials for Severe Insufficient Nutrition
Recruiting
The Effect of the Timing of Supplemental Parenteral Nutrition on the Prognosis of Critically Ill Patients (T-SPN)
Critical Illness, Organ Dysfunction
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.
Ángel Gil, PhD principal investigator
Departament of Biochemistry and Molecular Biology II. University of Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-Diet plus Standard and Jevity in people with Severe Insufficient Nutrition, run by Vegenat, S.A. at 1 site 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 4 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: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional status evaluation (time frame: 6 months). 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 24 Feb 2011.