Hospital UndernutritionINAPENNCT01342861
INAPEN Protocol for Impact of Breakfast Improvement
A study testing Addition of protein (milky food in the breakfast) in people with Hospital Undernutrition and Malnutrition, run by Centre Hospitalier de Meaux at 1 site in France.
Trial summary
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Undernutrition, Malnutrition, Nutritional Deficiency
- What is being tested?
- Addition of protein (milky food in the breakfast)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized for 8 days or more in the participant wards and capable of eating the proposed breakfast.
- According to the current care procedure, patients receiving an information document and offered the possibility of refusal.
Who cannot join
- End of life defined as an absence of curative treatment (limitation of care)
- Enteral or parenteral nutrition
- Need for limitations on oral nutrition (i.e. post-surgery)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Meaux
Meaux, 77
Xavier Forceville, MD, PhD, 164351176 ext. 33, x-forceville@ch-meaux.fr
François Thuillier, PD, 164351106 ext. 33, f-thuillier@ch-meaux.fr
About this study
Official title: INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, the investigators considered that breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care
Read the detailed description
INAPEN protocol for impact of breakfast improvement on the nutritional status of hospitalized patients (INcidence de l'Amélioration du Petit-déjeuner sur l'Etat Nutritinonel des patients hospitalisés)
Sponsored by Meaux Hospital (Centre Hospitalier de Meaux),
Financing: unrestricted grant from the French speaking society for enteral and parenteral nutrition [SFNEP: Société Francophone de nutrition entérale et parentérale].
Information provided by Meaux Hospital Center (Centre Hospitalier de Meaux) as per the protocol submitted to the SFNEP in 2009.
Purpose
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, we considered that breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care
Study Type: Interventional study in current care
Study design: Sequential cohorts, Efficacy study
Official title: Inapen Impact of breakfast improvement on the nutritional status of hospitalized patients (Incidence de l'amélioration du petit-déjeuner sur l'état nutritionnel des patients hospitalisés).
Further study details:
Primary outcome: Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7 Secondary outcomes: serum albumin concentration changes between D0 to D7, length of stay
Expected total enrollment: 800 patients (400 patients x 2).
Study start date: October 2009 Expected inclusion completion date: June 2011
Rationale:
It has long been known that more than half of hospitalized patients suffer from undernutrition [3-5]), consequently increasing length of stay of 2 to 6 days and morbidity [3]. Early nutrition has been shown to reduce length of stay and hospitalization costs [3, 6], but is mostly based on early enteral or parenteral nutrition. Our purpose was to evaluate the impact of an improved oral nutrition in mildly-challenged hospitalized patients. It is widely accepted that breakfast should deliver 25% of energy intake and nutritional requirements (ref4). A preliminary study found that the total protein and energy impact of breakfast in Meaux hospital was 4 g protein and 346 Kcal of total energy intake, whereas French institutional catering recommendations on nutrition (Groupe d'Etude des Marchés de Restauration Collective et de Nutrition, GEM RCN) stipulate 7.75 g of protein and 403 Kcal of energy.
The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively.
A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy. The second period of follow-up on the 400 patients was designed to evaluate the impacts of adding milky food to the breakfast and of educating health care professionals on the early detection of undernutrition. Efficacy will be evaluated based on increase in transthyretin concentrations, with special focus given to length of stay as a secondary end-point.
Eligibility Ages eligible for study: > 18 years. Both genders eligible for study.
Location and Contact Information France Rheumatology, Cardiology, Neurology, Pneumology departements Vascular and orthopedic surgery department
Study directorship and principal investigators Xavier Forceville, MD, PhD, Principal investigator Francois Thuillier, Pharmacist, CLAN chairman Karell Prieux-Lucas, Investigator Samia Touati, MD, Investigator
Further information
Study ID Number: CNIL : 909314 Health Authority: France CCTIRS : 09.358 (2009, september 10Th) Ethical committee: France, Ile-de-France XI (Saint Germain-en-Laye), August 17th, 2009
- Being tested
- Addition of protein (milky food in the breakfast)
- Keywords
- protein supplementation, caloric intake, breakfast, transthyretin (prealbumin), albumin, Length of stay
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Addition of protein (milky food in the breakfast)Dietary supplement
The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Observational period | Sham comparator | A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy Receives: Dietary Supplement: Addition of protein (milky food in the breakfast) |
| Intervention period | Experimental | The second period of follow-up on the 400 patients was designed to evaluate the impacts of adding milky food to the breakfast and of educating health care professionals on the early detection of undernutrition. Receives: Dietary Supplement: Addition of protein (milky food in the breakfast) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum transthyretin (prealbumin) concentration
Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7
Measured: changes between D0 to D7 between the 2 cohorts
Secondary outcomes (1)
serum albumin concentration changes and length of stay
serum albumin concentration changes between D0 to D7, length of stay
Measured: Changes between the 2 cohorts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hospital UndernutritionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Meaux
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342861
- Sponsor's protocol ID
- INAPEN
- Acronym
- INAPEN
- Status last verified
- Apr 2011
- First submitted
- 26 Apr 2011
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rapport complet de l'ANAES :Evaluation diagnostique de la dénutrition protéino-énergétique des adultes hospitalises. September 2003; http://www.has-sante.fr
Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. doi: 10.1177/0148607188012004371.
PubMed 3138447Circulaire DHOS/E1 N°2002-186 29/03/2002 relative à l'alimentation et la nutrition dans les établissements de santé: J off de la République Française 18/04/2002
Kudsk KA, Tolley EA, DeWitt RC, Janu PG, Blackwell AP, Yeary S, King BK. Preoperative albumin and surgical site identify surgical risk for major postoperative complications. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):1-9. doi: 10.1177/014860710302700101.
PubMed 12549591Edington J, Boorman J, Durrant ER, Perkins A, Giffin CV, James R, Thomson JM, Oldroyd JC, Smith JC, Torrance AD, Blackshaw V, Green S, Hill CJ, Berry C, McKenzie C, Vicca N, Ward JE, Coles SJ. Prevalence of malnutrition on admission to four hospitals in England. The Malnutrition Prevalence Group. Clin Nutr. 2000 Jun;19(3):191-5. doi: 10.1054/clnu.1999.0121.
PubMed 10895110Somanchi M, Tao X, Mullin GE. The facilitated early enteral and dietary management effectiveness trial in hospitalized patients with malnutrition. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):209-16. doi: 10.1177/0148607110392234.
PubMed 21378250
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INAPEN Protocol for Impact of Breakfast Improvement on the Nutritional Status of Hospitalized Patients (INcidence de l'Amélioration du Petit-déjeuner Sur l'Etat Nutritinonel Des Patients hospitalisés)
- ClinicalTrials.gov ID
- NCT01342861
- Acronym / sponsor ID
- INAPEN / INAPEN
- Keywords
- protein supplementation, caloric intake, breakfast, transthyretin (prealbumin), albumin, Length of stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Hospitalier de MeauxUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jun 2011 (estimated)
- First posted
- 27 Apr 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.
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, the investigators considered that breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care
Detailed description
INAPEN protocol for impact of breakfast improvement on the nutritional status of hospitalized patients (INcidence de l'Amélioration du Petit-déjeuner sur l'Etat Nutritinonel des patients hospitalisés)
Sponsored by Meaux Hospital (Centre Hospitalier de Meaux),
Financing: unrestricted grant from the French speaking society for enteral and parenteral nutrition [SFNEP: Société Francophone de nutrition entérale et parentérale].
Information provided by Meaux Hospital Center (Centre Hospitalier de Meaux) as per the protocol submitted to the SFNEP in 2009.
Purpose
Hospital undernutrition is a common health problem [1]. As a countermeasure, French hospitals have created a system of cross-function committees for feeding and nutrition called CLANs [Comité de Liaison pour l'alimentation et la nutrition] [2]. Potential actions for improving patient nutritional status include improving the characteristics of the food provided to increase both protein and calorie intake in at-risk patients that do not require enteral or parenteral nutrition. Looking at the various daily meals, we considered that breakfast following the night fast would be the easiest meal to improve .
Condition Intervention Phase Patients scheduled for hospitalization of over 4 days Addition of protein (milky food in the breakfast) Current care
Study Type: Interventional study in current care
Study design: Sequential cohorts, Efficacy study
Official title: Inapen Impact of breakfast improvement on the nutritional status of hospitalized patients (Incidence de l'amélioration du petit-déjeuner sur l'état nutritionnel des patients hospitalisés).
Further study details:
Primary outcome: Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7 Secondary outcomes: serum albumin concentration changes between D0 to D7, length of stay
Expected total enrollment: 800 patients (400 patients x 2).
Study start date: October 2009 Expected inclusion completion date: June 2011
Rationale:
It has long been known that more than half of hospitalized patients suffer from undernutrition [3-5]), consequently increasing length of stay of 2 to 6 days and morbidity [3]. Early nutrition has been shown to reduce length of stay and hospitalization costs [3, 6], but is mostly based on early enteral or parenteral nutrition. Our purpose was to evaluate the impact of an improved oral nutrition in mildly-challenged hospitalized patients. It is widely accepted that breakfast should deliver 25% of energy intake and nutritional requirements (ref4). A preliminary study found that the total protein and energy impact of breakfast in Meaux hospital was 4 g protein and 346 Kcal of total energy intake, whereas French institutional catering recommendations on nutrition (Groupe d'Etude des Marchés de Restauration Collective et de Nutrition, GEM RCN) stipulate 7.75 g of protein and 403 Kcal of energy.
The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively.
A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy. The second period of follow-up on the 400 patients was designed to evaluate the impacts of adding milky food to the breakfast and of educating health care professionals on the early detection of undernutrition. Efficacy will be evaluated based on increase in transthyretin concentrations, with special focus given to length of stay as a secondary end-point.
Eligibility Ages eligible for study: > 18 years. Both genders eligible for study.
Location and Contact Information France Rheumatology, Cardiology, Neurology, Pneumology departements Vascular and orthopedic surgery department
Study directorship and principal investigators Xavier Forceville, MD, PhD, Principal investigator Francois Thuillier, Pharmacist, CLAN chairman Karell Prieux-Lucas, Investigator Samia Touati, MD, Investigator
Further information
Study ID Number: CNIL : 909314 Health Authority: France CCTIRS : 09.358 (2009, september 10Th) Ethical committee: France, Ile-de-France XI (Saint Germain-en-Laye), August 17th, 2009
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Observational period | Sham comparator | Dietary Supplement: Addition of protein (milky food in the breakfast)A first period of follow-up on the 400 patients was designed to survey and evaluate current nutrition administration policy |
| Intervention period | Experimental | Dietary Supplement: Addition of protein (milky food in the breakfast)The second period of follow-up on the 400 patients was designed to evaluate the impacts of adding milky food to the breakfast and of educating health care professionals on the early detection of undernutrition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients hospitalized for 8 days or more in the participant wards and capable of eating the proposed breakfast.
- According to the current care procedure, patients receiving an information document and offered the possibility of refusal.
Key exclusion criteria (3 listed)
- End of life defined as an absence of curative treatment (limitation of care)
- Enteral or parenteral nutrition
- Need for limitations on oral nutrition (i.e. post-surgery)
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 |
|---|---|---|
| Addition of protein (milky food in the breakfast)The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively. | Dietary supplement | Intervention period, Observational period |
Primary outcome
serum transthyretin (prealbumin) concentration
Time frame: changes between D0 to D7 between the 2 cohorts
Improvement of serum transthyretin (prealbumin) concentration changes between D0 to D7
1 secondary outcome
serum albumin concentration changes and length of stay
Time frame: Changes between the 2 cohorts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
- BackgroundRapport complet de l'ANAES :Evaluation diagnostique de la dénutrition protéino-énergétique des adultes hospitalises. September 2003; http://www.has-sante.fr
- Background: PubMed 3138447Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. doi: 10.1177/0148607188012004371.
- BackgroundCirculaire DHOS/E1 N°2002-186 29/03/2002 relative à l'alimentation et la nutrition dans les établissements de santé: J off de la République Française 18/04/2002
- Background: PubMed 12549591Kudsk KA, Tolley EA, DeWitt RC, Janu PG, Blackwell AP, Yeary S, King BK. Preoperative albumin and surgical site identify surgical risk for major postoperative complications. JPEN J Parenter Enteral Nutr. 2003 Jan-Feb;27(1):1-9. doi: 10.1177/014860710302700101.
- Background: PubMed 10895110Edington J, Boorman J, Durrant ER, Perkins A, Giffin CV, James R, Thomson JM, Oldroyd JC, Smith JC, Torrance AD, Blackshaw V, Green S, Hill CJ, Berry C, McKenzie C, Vicca N, Ward JE, Coles SJ. Prevalence of malnutrition on admission to four hospitals in England. The Malnutrition Prevalence Group. Clin Nutr. 2000 Jun;19(3):191-5. doi: 10.1054/clnu.1999.0121.
- Background: PubMed 21378250Somanchi M, Tao X, Mullin GE. The facilitated early enteral and dietary management effectiveness trial in hospitalized patients with malnutrition. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):209-16. doi: 10.1177/0148607110392234.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Addition of protein (milky food in the breakfast) in people with Hospital Undernutrition and Malnutrition, run by Centre Hospitalier de Meaux at 1 site 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 2 inclusion and 3 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 27 Apr 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 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. Some participants in this study may receive a placebo. 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 Xavier Forceville, MD, PhD (164351176 ext. 33, x-forceville@ch-meaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum transthyretin (prealbumin) concentration (time frame: changes between D0 to D7 between the 2 cohorts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01342861, which also lists 6 linked publications.
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 27 Apr 2011.