MalnutritionNutri-PANCT00877578
Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients
A study testing Nutri-Energie ®, Aliscience society and Clinutren 1.5 ®, Nestlé Clinical Nutrition in people with Malnutrition, run by University Hospital, Rouen at 2 sites in France.
Trial summary
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability. Read more about this study
- Who is it for?
- Ages 60 to 95 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Nutri-Energie ®, Aliscience society and Clinutren 1.5 ®, Nestlé Clinical Nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2009to Jul 2011
- 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 60 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female participants
- Moderately malnourished defined by whether:
- 18 < BMI < 21
- 5 to 10% body weight loss in the last past 6 months.
- Buzby index between 83.5 and 97.5 (calculated with weight loss and albumin)
- With or without any factors increasing malnutrition (insufficient caloric intakes, long term treatment)
- Justifying hospitalisation in rehabilitation unit
Who cannot join
- Age < 70 years old or > 90 years old
- Surgical affection involving a surgery in the next 10 days
- Contraindicated oral intakes due to digestive injury
- Total parenteral nutrition
- Ulcer or infection existing
- Malignant hemopathy
Show all 11Show fewer
- Hepatic insufficiency (TP < 30%)
- Swallowing difficulties limiting solid oral intakes
- Kidney failure (renal dialysis)
- Expected survival > 3 months
- Impossibility to give an informed consent
Trial locations and contacts
2 sites in 1 country.
About this study
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.
The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.
Read the detailed description
Ageing of the population and loss of autonomy expose to major consequences in terms of treatment charges and need for hospitalisation. Malnutrition has a key prognostic value, that worsen the prognosis of the primary disease; the length of hospital stay and the incidence of complications are related to nutritional status (Correia 2003, Pichard 2004, Schneider 2004). Several large scale studies at Rouen University Hospital, in 1998 and 2001, have revealed on more than 1000 patients (mid age 71 years) that malnutrition prevalence ranged of 35 to 38%, one third of which is severe (Jusserand 2000, Delaire 2002). Malnutrition increases the risk of complications (Naber 1997, Correia 2003), including muscle mass depletion, decrease of immune function and delayed wound healing. The main consequence of malnutrition is increased infectious morbidity and post operative mortality for the weakest patients. Increased length of hospital stay and rehabilitation duration also results in increased medicals and social burden, in particular in the elderly patients.
Recent studies have shown that usual hospital food intake was insufficient to cover patient's needs (Hébuterne 2001, Dupertuis 2003, Petit 2004) and that systematic nutritional screening was mandatory in hospitalised patients, using validated criteria and scales (e.g. NutriSteps®, MNA®).
The strategy for nutritional support includes as a first step enriched diets and the use of oral supplements, then enteral nutrition or even parenteral nutrition in the most severe cases (HAS guidelines 2007). The efficacy of oral supplementation has been proven (Stratton 2007). Yet, their composition still need to be optimised to better match specific nutritional needs and to ameliorate palatability and favour compliance.
The provision of specifics nutrients with anabolic, anti-oxidants or anti-inflammatory effects can optimise oral nutritional supplements, to achieve a true pharmaco-nutritional therapy. Accordingly, leucine enrichment has inhibitory effects on proteasome-mediated muscular proteolysis in aged rats (Combaret 2005). Trace elements deficiency (zinc, selenium, chromium, iron) is common in the elderly patients and increase the risk of infectious or wound complications (HAS 2007), and the level of trace elements provision in standard supplements may be insufficient to compensate this deficiency. Finally, omega-3 fatty acids enrichment enables to limit the inflammatory response and hypercatabolism (Delarue 2005).
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.
- Conditions
- Malnutrition
- Being tested
- Nutri-Energie ®, Aliscience society, Clinutren 1.5 ®, Nestlé Clinical Nutrition
- Keywords
- elderly patient, malnutrition, new nutritional support, micronutrients, elderly patient malnutrition
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutri-Energie ®, Aliscience societyDietary supplement
Nutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients.
Clinutren 1.5 ®, Nestlé Clinical NutritionDietary supplement
Clinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nutri-Energie ®, a cake of high caloric density and palatability, twice a day for 4 weeks, in addition to an enriched diet. Receives: Dietary Supplement: Nutri-Energie ®, Aliscience society |
| 2 | Active comparator | Clinutren 1.5 ® standard isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet. Receives: Dietary Supplement: Clinutren 1.5 ®, Nestlé Clinical Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome of fat-free mass measured by multiple frequence bio-impedance analysis
Measured: 28 days
Secondary outcomes (1)
safety of oral supplementation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre DECHELOTTE, PR, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877578
- Sponsor's protocol ID
- 2007/023/HP
- Acronym
- Nutri-PA
- Status last verified
- Oct 2013
- First submitted
- 7 Apr 2009
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Special Oral Nutritional Supplement on Nutritional Status of Malnourished Elderly Patients
- ClinicalTrials.gov ID
- NCT00877578
- Acronym / sponsor ID
- Nutri-PA / 2007/023/HP
- Conditions
- Malnutrition
- Keywords
- elderly patient, malnutrition, new nutritional support, micronutrients, elderly patient malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Apr 2009 (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 aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.
The primary endpoint is the outcome of fat-free mass measured by multiple frequence bio-impedance analysis.
Detailed description
Ageing of the population and loss of autonomy expose to major consequences in terms of treatment charges and need for hospitalisation. Malnutrition has a key prognostic value, that worsen the prognosis of the primary disease; the length of hospital stay and the incidence of complications are related to nutritional status (Correia 2003, Pichard 2004, Schneider 2004). Several large scale studies at Rouen University Hospital, in 1998 and 2001, have revealed on more than 1000 patients (mid age 71 years) that malnutrition prevalence ranged of 35 to 38%, one third of which is severe (Jusserand 2000, Delaire 2002). Malnutrition increases the risk of complications (Naber 1997, Correia 2003), including muscle mass depletion, decrease of immune function and delayed wound healing. The main consequence of malnutrition is increased infectious morbidity and post operative mortality for the weakest patients. Increased length of hospital stay and rehabilitation duration also results in increased medicals and social burden, in particular in the elderly patients.
Recent studies have shown that usual hospital food intake was insufficient to cover patient's needs (Hébuterne 2001, Dupertuis 2003, Petit 2004) and that systematic nutritional screening was mandatory in hospitalised patients, using validated criteria and scales (e.g. NutriSteps®, MNA®).
The strategy for nutritional support includes as a first step enriched diets and the use of oral supplements, then enteral nutrition or even parenteral nutrition in the most severe cases (HAS guidelines 2007). The efficacy of oral supplementation has been proven (Stratton 2007). Yet, their composition still need to be optimised to better match specific nutritional needs and to ameliorate palatability and favour compliance.
The provision of specifics nutrients with anabolic, anti-oxidants or anti-inflammatory effects can optimise oral nutritional supplements, to achieve a true pharmaco-nutritional therapy. Accordingly, leucine enrichment has inhibitory effects on proteasome-mediated muscular proteolysis in aged rats (Combaret 2005). Trace elements deficiency (zinc, selenium, chromium, iron) is common in the elderly patients and increase the risk of infectious or wound complications (HAS 2007), and the level of trace elements provision in standard supplements may be insufficient to compensate this deficiency. Finally, omega-3 fatty acids enrichment enables to limit the inflammatory response and hypercatabolism (Delarue 2005).
The aim of this study is to evaluate in malnourished elderly patients the nutritional efficacy of a new nutritional supplement enriched in different specific pharmaco nutrients (leucine, micronutrients, omega-3) appearing in the form of a cake of high caloric density and palatability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Nutri-Energie ®, Aliscience societyNutri-Energie ®, a cake of high caloric density and palatability, twice a day for 4 weeks, in addition to an enriched diet. |
| 2 | Active comparator | Dietary Supplement: Clinutren 1.5 ®, Nestlé Clinical NutritionClinutren 1.5 ® standard isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both male and female participants
- Moderately malnourished defined by whether:
- 18 < BMI < 21
- 5 to 10% body weight loss in the last past 6 months.
- Buzby index between 83.5 and 97.5 (calculated with weight loss and albumin)
Key exclusion criteria (11 listed)
- Age < 70 years old or > 90 years old
- Surgical affection involving a surgery in the next 10 days
- Contraindicated oral intakes due to digestive injury
- Total parenteral nutrition
- Ulcer or infection existing
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 |
|---|---|---|
| Nutri-Energie ®, Aliscience societyNutri-Energie ® is a new cake of high caloric density and palatability, enriched in different specific pharmaco nutrients. | Dietary supplement | 1 |
| Clinutren 1.5 ®, Nestlé Clinical NutritionClinutren 1.5 ®, isocaloric commercially available supplement, twice a day for 4 weeks, in addition to an enriched diet | Dietary supplement | 2 |
Primary outcome
outcome of fat-free mass measured by multiple frequence bio-impedance analysis
Time frame: 28 days
1 secondary outcome
safety of oral supplementation
Time frame: 28 days
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 16 Oct 2013.
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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.
Pierre DECHELOTTE, PR principal investigator
University Hospital, Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutri-Energie ®, Aliscience society and Clinutren 1.5 ®, Nestlé Clinical Nutrition in people with Malnutrition, run by University Hospital, Rouen at 2 sites in France.
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 7 inclusion and 11 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 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
outcome of fat-free mass measured by multiple frequence bio-impedance analysis (time frame: 28 days). 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 16 Oct 2013.