Malnourished ElderlyRebootNCT02396121
Micronutrient and Malnourished Elderly
A study testing Oral nutritional supplement : Renutryl® Booster in people with Malnourished Elderly, run by Société des Produits Nestlé (SPN).
Trial summary
The purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Malnourished Elderly
- What is being tested?
- Oral nutritional supplement : Renutryl® Booster
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jun 2014
- 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
- Age : above or equal to 70 years
- AND :
- Weight loss above or equal to 5% in one month
- OR weight loss above or equal to 10% in 6 months
- OR BMI between 18 and 21
- OR albuminaemia between 30 and 35 g/L
- OR MNA-SF less or equal to 7
Who cannot join
- Severe malnutrition
- Contraindication to oral nutrition
- Severe pathologies
- Inflammatory syndrome (CRP > 30 mg/L)
- Severe dementia (Mini Mental Score < 10)
About this study
Official title: Évaluation de l'évolution du Statut Nutritionnel en Micronutriment Chez Les Patients âgés dénutris bénéficiant d'Une complémentation Nutritionnelle Orale
The purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.
- Conditions
- Malnourished Elderly
- Being tested
- Oral nutritional supplement : Renutryl® Booster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral nutritional supplement : Renutryl® BoosterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Administration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days. Receives: Dietary Supplement: Oral nutritional supplement : Renutryl® Booster |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in micronutrients status after 28 days
Biological analyses of micronutrient
Measured: 28 days
Secondary outcomes (4)
Nutritional status
Weight, albumin, transthyretin, CRP, Mini Nutritional Assessment Short-Form (MNA-SF)
Measured: 28 days
Body composition
Impedance measurement
Measured: 28 days
Compliance
Compliance measured by bottle weight before and after consumption
Measured: 28 days
Autonomy
"Get up and go" test
Measured: 28 fays
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startNov 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malnourished ElderlyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396121
- Sponsor's protocol ID
- 12.01.FR.NHS
- Acronym
- Reboot
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation de l'évolution du Statut Nutritionnel en Micronutriment Chez Les Patients âgés dénutris bénéficiant d'Une complémentation Nutritionnelle Orale
- ClinicalTrials.gov ID
- NCT02396121
- Acronym / sponsor ID
- Reboot / 12.01.FR.NHS
- Conditions
- Malnourished Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 24 Mar 2015 (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 purpose of this study is to evaluate the micronutrient status of malnourished elderly after oral nutritional supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Dietary Supplement: Oral nutritional supplement : Renutryl® BoosterAdministration of 1 bottle of an oral nutritional supplement, Renutryl® Booster (600 kcal), during 28 days. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age : above or equal to 70 years
- Weight loss above or equal to 5% in one month
- OR weight loss above or equal to 10% in 6 months
- OR BMI between 18 and 21
- OR albuminaemia between 30 and 35 g/L
Key exclusion criteria (5 listed)
- Severe malnutrition
- Contraindication to oral nutrition
- Severe pathologies
- Inflammatory syndrome (CRP > 30 mg/L)
- Severe dementia (Mini Mental Score < 10)
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 |
|---|---|---|
| Oral nutritional supplement : Renutryl® Booster | Dietary supplement | Interventional |
Primary outcome
Change from baseline in micronutrients status after 28 days
Time frame: 28 days
Biological analyses of micronutrient
4 secondary outcomes
Nutritional status
Time frame: 28 days
Body composition
Time frame: 28 days
Compliance
Time frame: 28 days
Autonomy
Time frame: 28 fays
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 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oral nutritional supplement : Renutryl® Booster in people with Malnourished Elderly, run by Société des Produits Nestlé (SPN).
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 5 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 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from baseline in micronutrients status after 28 days (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 24 Mar 2015; AzTrials last refreshed its copy on 28 Oct 2026.