Elderly PeopleNCT02262091
Immune Benefits of WGP in Elderly
A study testing Food fibers, Maltodextrin and Influenza vaccine (incl. criterion) in people with Elderly People, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
Trial summary
The aim of this research is to assess the immune enhancing property of food fibers in the elderly population. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Elderly People
- What is being tested?
- Food fibers, Maltodextrin and Influenza vaccine (incl. criterion)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2014to Dec 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
- Older adult
Who may be able to join
- Male and female elderly volunteers equal or above age of 70
- Pre-frail and frail subjects (based on Fried's criteria)
- Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
- Having obtained his/her (or his/her legal representative's) informed consent
Who cannot join
- Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
- Allergy to eggs or influenza vaccine components.
- Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
- Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
- Subject who has taken antibiotics in the last 2 months prior to entering the study.
- Subject who is consuming regularly prebiotic and/or probiotic supplements, yogurts, and/or other dietary supplements.
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- Personal or family history of Guillain-Barre syndrome
- BMI>35 kg/m2
- Subject who has received blood transfusion or had a blood donation during the last 4 weeks prior to the beginning of this study.
- Subject who cannot be expected to comply with the study procedures
- Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Leiter des Geriatrischen Zentrums Oldenburg (GZO)
Oldenburg, 26133
About this study
Official title: Strengthening Immunity of Prefrail and Frail Elderly by WGP
The aim of this research is to assess the immune enhancing property of food fibers in the elderly population.
- Conditions
- Elderly People
- Being tested
- Food fibers, Maltodextrin, Influenza vaccine (incl. criterion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food fibersDietary supplement
MaltodextrinDietary supplement
Influenza vaccine (incl. criterion)Biological
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin; Biological: Influenza vaccine (incl. criterion) |
| Food fibers | Experimental | Not described Receives: Dietary Supplement: Food fibers; Biological: Influenza vaccine (incl. criterion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 4 weeks post-vaccination in antibody titers levels
Measured: Up to 1 month
Secondary outcomes (4)
Measure of seroconversion
Measured: Up to 2 months
Measure of cytokines production
Measured: Up to 2 months 2014
Measure the occurence of clinical endpoints
Measured: Up to 2 months
Measure of seroprotection
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly PeopleStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
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
- NCT02262091
- Sponsor's protocol ID
- 12.22.NRC
- Status last verified
- Sep 2014
- First submitted
- 8 Oct 2013
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauer JM, De Castro A, Bosco N, Romagny C, Diekmann R, Benyacoub J, Vidal K. Influenza vaccine response in community-dwelling German prefrail and frail individuals. Immun Ageing. 2017 Jul 6;14:17. doi: 10.1186/s12979-017-0098-z. eCollection 2017.
PubMed 28694834
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Immunity of Prefrail and Frail Elderly by WGP
- ClinicalTrials.gov ID
- NCT02262091
- Acronym / sponsor ID
- 12.22.NRC
- Conditions
- Elderly People
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Oct 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 aim of this research is to assess the immune enhancing property of food fibers in the elderly population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Dietary Supplement: Maltodextrin, Biological: Influenza vaccine (incl. criterion) |
| Food fibers | Experimental | Dietary Supplement: Food fibers, Biological: Influenza vaccine (incl. criterion) |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Male and female elderly volunteers equal or above age of 70
- Pre-frail and frail subjects (based on Fried's criteria)
- Willing to be vaccinated against influenza and having no contraindication to receive influenza vaccination
- Having obtained his/her (or his/her legal representative's) informed consent
Key exclusion criteria (11 listed)
- Subject with a rapidly deteriorating health status (terminal, severe, or uncontrolled acute/chronic diseases)
- Allergy to eggs or influenza vaccine components.
- Subject who has received any vaccination in the last 3 months or has previously been vaccinated with the current seasonal influenza vaccine.
- Subject who is currently taking, or has taken in the last 4 weeks, or will take immune modulating medication during the study, including steroid, immune suppressive treatment.
- Subject who has taken antibiotics in the last 2 months prior to entering the 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 |
|---|---|---|
| Food fibers | Dietary supplement | Food fibers |
| Maltodextrin | Dietary supplement | Placebo group |
| Influenza vaccine (incl. criterion) | Biological | Food fibers, Placebo group |
Primary outcome
Change from baseline at 4 weeks post-vaccination in antibody titers levels
Time frame: Up to 1 month
4 secondary outcomes
Measure of seroconversion
Time frame: Up to 2 months
Measure of cytokines production
Time frame: Up to 2 months 2014
Measure the occurence of clinical endpoints
Time frame: Up to 2 months
Measure of seroprotection
Time frame: Up to 2 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 10 Apr 2015.
- Derived from this study: PubMed 28694834Bauer JM, De Castro A, Bosco N, Romagny C, Diekmann R, Benyacoub J, Vidal K. Influenza vaccine response in community-dwelling German prefrail and frail individuals. Immun Ageing. 2017 Jul 6;14:17. doi: 10.1186/s12979-017-0098-z. eCollection 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food fibers, Maltodextrin and Influenza vaccine (incl. criterion) in people with Elderly People, run by Société des Produits Nestlé (SPN) at 1 site in Germany.
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 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 10 Apr 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 Germany. 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?
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 at 4 weeks post-vaccination in antibody titers levels (time frame: Up to 1 month). 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 NCT02262091, which also lists 1 linked publication.
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 10 Apr 2015.