NCT05078346

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2022

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

August 26, 2021

Last Update Submit

February 3, 2022

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (4)

  • Percentage of different immune cell types in whole blood

    Immune cell type profiling in whole blood by mass cytometry

    6 - 12 months after the start of the trial

  • Relative quantification of immune protein in plasma

    Proteomic analysis in plasma by proximity extension assay

    6 - 12 months after the start of the trial

  • Amount of cytokines expressed by peripheral blood mononuclear cells

    Cytokine quantification by proximity extension assay

    6 - 12 months after the start of the trial

  • Amount of analytes in serum

    Blood chemistry

    6 - 12 months after the start of the trial

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • Ability to understand and sign the informed consent
  • Healthy adult men and/or women, 35-65 years old
  • BMI \>18 and \<30 kg/m2

You may not qualify if:

  • Volunteer who cannot be expected to comply with the protocol
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nestlé Clinical Research Unit

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Biospecimen

Retention: NONE RETAINED

blood

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2021

First Posted

October 14, 2021

Study Start

June 2, 2021

Primary Completion

January 28, 2022

Study Completion

February 3, 2022

Last Updated

February 4, 2022

Record last verified: 2022-02

Locations

CH(1)