Immune Fitness Prediction

Healthy Adults Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078346
• Other study ID #: 2024_NR
• Status: Completed
• Start date: June 2, 2021
• Est. completion date: February 3, 2022

Study information

• Verified date: February 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 3, 2022
• Est. primary completion date: January 28, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Locations

Country	Name	City	State
Switzerland	Nestlé Clinical Research Unit	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Relative quantification of immune protein in plasma	Proteomic analysis in plasma by proximity extension assay	6 - 12 months after the start of the trial
Primary	Amount of cytokines expressed by peripheral blood mononuclear cells	Cytokine quantification by proximity extension assay	6 - 12 months after the start of the trial
Primary	Amount of analytes in serum	Blood chemistry	6 - 12 months after the start of the trial