Healthy AdultsNCT05078346
Immune Fitness Prediction
An observational study of Healthy Adults, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The overall objective of the study is to determine whether self-rated, perceived immune fitness (using questionnaire) is associated with biological assessment of immune fitness (immune signatures in the blood). Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jun 2021to 3 Feb 2022
- Phase
- Observational
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Ability to understand and sign the informed consent
- Healthy adult men and/or women, 35-65 years old
- BMI >18 and <30 kg/m2
Who cannot join
- Volunteer who cannot be expected to comply with the protocol
- Individuals with self-reported chronic disease; or who have any clinical condition which the investigator deems relevant for exclusion from the study,
- Individuals with an impaired immune system that may confound immune response testing; i.e. any condition that impairs participant immune response through either the condition itself or through the treatment of the condition,
- Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nestlé Clinical Research Unit
Lausanne, Canton of Vaud, 1000
About this study
Official title: Observational Study to Determine the Association Between Self-rated, Perceived Immune Fitness (Using Questionnaire) With Biological Assessment of Immune Fitness (Immune Signatures in the Blood).
The overall objective of the study is to determine whether self-rated, perceived immune fitness (using questionnaire) is associated with biological assessment of immune fitness (immune signatures in the blood).
- Conditions
- Healthy Adults
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of different immune cell types in whole blood
Immune cell type profiling in whole blood by mass cytometry
Measured: 6 - 12 months after the start of the trial
Relative quantification of immune protein in plasma
Proteomic analysis in plasma by proximity extension assay
Measured: 6 - 12 months after the start of the trial
Amount of cytokines expressed by peripheral blood mononuclear cells
Cytokine quantification by proximity extension assay
Measured: 6 - 12 months after the start of the trial
Amount of analytes in serum
Blood chemistry
Measured: 6 - 12 months after the start of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start2 Jun 2021
- Primary completion28 Jan 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 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
- NCT05078346
- Sponsor's protocol ID
- 2024_NR
- Status last verified
- Feb 2022
- First submitted
- 26 Aug 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Determine the Association Between Self-rated, Perceived Immune Fitness (Using Questionnaire) With Biological Assessment of Immune Fitness (Immune Signatures in the Blood).
- ClinicalTrials.gov ID
- NCT05078346
- Acronym / sponsor ID
- 2024_NR
- Conditions
- Healthy Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- 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 overall objective of the study is to determine whether self-rated, perceived immune fitness (using questionnaire) is associated with biological assessment of immune fitness (immune signatures in the blood).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (3 listed)
- Ability to understand and sign the informed consent
- Healthy adult men and/or women, 35-65 years old
- BMI >18 and <30 kg/m2
Key exclusion criteria (4 listed)
- Volunteer who cannot be expected to comply with the protocol
- Individuals with self-reported chronic disease; or who have any clinical condition which the investigator deems relevant for exclusion from the study,
- Individuals with an impaired immune system that may confound immune response testing; i.e. any condition that impairs participant immune response through either the condition itself or through the treatment of the condition,
- Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of different immune cell types in whole blood
Time frame: 6 - 12 months after the start of the trial
Immune cell type profiling in whole blood by mass cytometry
Relative quantification of immune protein in plasma
Time frame: 6 - 12 months after the start of the trial
Proteomic analysis in plasma by proximity extension assay
Amount of cytokines expressed by peripheral blood mononuclear cells
Time frame: 6 - 12 months after the start of the trial
Cytokine quantification by proximity extension assay
Amount of analytes in serum
Time frame: 6 - 12 months after the start of the trial
Blood chemistry
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 4 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Healthy Participants
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?
An observational study of Healthy Adults, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 3 inclusion and 4 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 4 Feb 2022. 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 Switzerland. 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?
Percentage of different immune cell types in whole blood (time frame: 6 - 12 months after the start of the trial). The study lists 4 primary outcomes in all. 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 4 Feb 2022.