MalnutritionPhase 2PRESAGE-T2NCT02117609
Effect of a New High-protein Oral Supplement on Functional Parameters in Patients in Nursing Homes
A Phase 2 study testing New DELICAL formula and Standard DELICAL formula in people with Malnutrition, run by Lactalis at 1 site in France.
Trial summary
The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- New DELICAL formula and Standard DELICAL formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- May 2012to Jun 2015
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or woman aged more than 60 years old
- Living in a nursing home for at least 2 months
- Malnourished or at risk of malnutrition (MNA<23.5 or BMI<24 or albumin<35 g/l or weight loss of more than 5 kg in the last 6 months)
- Without dementia or with moderate dementia (MMSE > or =10/30)
- Able to walk without human assistance (technical assistance allowed)
- No vitamin D supplementation
- Able to follow the study procedures and agreed to consume oral supplement
Who cannot join
- Severe dementia (MMSE < 10/30)
- Enteral nutrition
- Severe renal or hepatic impairment
- Cancer with chemotherapy
- Uncontrolled diabetes
- Lactose intolerance
- Cow's milk protein allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution
The objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.
- Conditions
- Malnutrition
- Being tested
- New DELICAL formula, Standard DELICAL formula
- Keywords
- Elderly, Nursing home, Functional impairment, High-protein oral supplement
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New DELICAL formulaDietary supplement
3 months with the option of continuing until 6 months.
Standard DELICAL formulaDietary supplement
3 months with the option of continuing until 6 months.
| Study group | Role | What they receive |
|---|---|---|
| New DELICAL formula | Experimental | New high-protein oral nutrient supplement Receives: Dietary Supplement: New DELICAL formula |
| Standard DELICAL formula | Active comparator | Standard isoenergetic isoprotein formula Receives: Dietary Supplement: Standard DELICAL formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 4-meter walking speed
Measured: After 3 months and 6 months
Secondary outcomes (8)
Change from baseline in grip strength
Measured: After 3 months and 6 months
Change from baseline in ADL (Activities Daily Living) score
Measured: After 3 months and 6 months
Change from baseline in Geriatric Depression Scale
Measured: After 3 months and 6 months
Change from baseline in quality of life (QOL-AD)
Measured: After 3 months and 6 months
Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)
Measured: During the 3 months and/or 6 months of consumption
Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)
Measured: After 3 months and 6 months
Change from baseline in nutritional status (Mini Nutritional Assessment)
Measured: After 3 months and 6 months
Changes from baseline in blood parameters
Inflammation markers (TNFalpha, TNF-R1, TNF-R2, IL 15), Fatty acid composition of red blood cell membranes, Fibrinogen, CRP, albumin, prealbumin, orosomucoid, IGF-1, cystein, glutathione peroxidase, oxidized and reduced glutathione
Measured: After 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionJun 2015
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.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Toulouse, University of Lille Nord de France, National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Yves Rolland, Pr, Principal investigator, University Hospital, ToulouseCécile Bonhomme, PhD, Study director, Lactalis Nutrition SantéDavid Seguy, Dr, Study chair, U995, Université Lille Nord FranceCharlotte Baudry, PhD, Study chair, Lactalis Recherche et Développement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117609
- Sponsor's protocol ID
- LRD-2011-PRESAGE
- Other IDs
- ANR ALIA2010-01306 Presage
- Acronym
- PRESAGE-T2
- Status last verified
- Oct 2015
- First submitted
- 16 Apr 2014
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effet d'Une supplémentation Avec Une Nouvelle préparation hyperprotéinée et Hypercalorique Sur l'évolution Des paramètres Fonctionnels, Nutritionnels et Cognitifs Chez la Personne âgée en Institution
- ClinicalTrials.gov ID
- NCT02117609
- Acronym / sponsor ID
- PRESAGE-T2 / LRD-2011-PRESAGE
- Conditions
- Malnutrition
- Keywords
- Elderly, Nursing home, Functional impairment, High-protein oral supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Toulouse, University of Lille Nord de France, National Research Agency, France
- Study start
- May 2012
- Primary completion
- Jun 2015 (actual)
- First posted
- 21 Apr 2014 (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 objective of this study is to determine whether a supplementation with a new high-protein oral supplement can improve the evolution of functional parameters in elderly patients in nursing homes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New DELICAL formula | Experimental | Dietary Supplement: New DELICAL formulaNew high-protein oral nutrient supplement |
| Standard DELICAL formula | Active comparator | Dietary Supplement: Standard DELICAL formulaStandard isoenergetic isoprotein formula |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or woman aged more than 60 years old
- Living in a nursing home for at least 2 months
- Malnourished or at risk of malnutrition (MNA<23.5 or BMI<24 or albumin<35 g/l or weight loss of more than 5 kg in the last 6 months)
- Without dementia or with moderate dementia (MMSE > or =10/30)
- Able to walk without human assistance (technical assistance allowed)
Key exclusion criteria (7 listed)
- Severe dementia (MMSE < 10/30)
- Enteral nutrition
- Severe renal or hepatic impairment
- Cancer with chemotherapy
- Uncontrolled diabetes
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 |
|---|---|---|
| New DELICAL formula3 months with the option of continuing until 6 months. | Dietary supplement | New DELICAL formula |
| Standard DELICAL formula3 months with the option of continuing until 6 months. | Dietary supplement | Standard DELICAL formula |
Primary outcome
Change from baseline in 4-meter walking speed
Time frame: After 3 months and 6 months
8 secondary outcomes
Change from baseline in grip strength
Time frame: After 3 months and 6 months
Change from baseline in ADL (Activities Daily Living) score
Time frame: After 3 months and 6 months
Change from baseline in Geriatric Depression Scale
Time frame: After 3 months and 6 months
Change from baseline in quality of life (QOL-AD)
Time frame: After 3 months and 6 months
Frequency of pathologic adverse events (disease, acute infection, falls, hospitalization)
Time frame: During the 3 months and/or 6 months of consumption
Change from baseline in body composition measured by bioelectrical impedence analysis (BIA)
Time frame: After 3 months and 6 months
Change from baseline in nutritional status (Mini Nutritional Assessment)
Time frame: After 3 months and 6 months
Changes from baseline in blood parameters
Time frame: After 3 months and 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 7 Oct 2015.
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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.
Yves Rolland, Pr principal investigator
University Hospital, Toulouse
Cécile Bonhomme, PhD study director
Lactalis Nutrition Santé
David Seguy, Dr study chair
U995, Université Lille Nord France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing New DELICAL formula and Standard DELICAL formula in people with Malnutrition, run by Lactalis 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 7 inclusion and 7 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 7 Oct 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in 4-meter walking speed (time frame: After 3 months and 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 7 Oct 2015.