Immune Fitness Prediction

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).

Study Overview

• Status: Completed
• Conditions: Healthy Adults

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • Nestlé Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Volunteer who cannot be expected to comply with the protocol
2. Individuals with self-reported chronic disease; or who have any clinical condition which the investigator deems relevant for exclusion from the study,
3. 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,
4. Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): January 28, 2022
• Study Completion (Actual): February 3, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: September 30, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2024_NR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No