FIT to Grow Old - Functionality of the Immune System and Healthy Aging
FTGO
1 other identifier
observational
156
1 country
1
Brief Summary
Aging is commonly associated with reduced functionality of the immune system, resulting in a higher prevalence of infectious disease, auto-immune disease, cancer, and lower efficiency of vaccination. Nutritional strategies are increasingly recognized as a method to improve immune functionality, as several nutrients are shown to exert immunomodulatory properties. However, the large variation between individuals with regard to immune responses asks for more personalized approaches. Therefore, this field of research would benefit from a selection of those individuals with immune dysfunction. It is recently shown that immune functionality is largely dependent on intracellular metabolism, leading to the introduction of the new term 'immune cell fitness' which combines the metabolic and functional status of an immune cell. Within this study, we will determine the immune cell fitness of monocytes from healthy young adults and elderly subjects by measuring and integrating a broad range of metabolic and functional immune parameters into an immune cell fitness score. We aim to identify those individuals with immune dysfunction, the unfit. Furthermore, to identify potential nutritional strategies to improve immune cell fitness, we will study the effects of metabolites and nutrients on the immune cell fitness status of monocytes from elderly subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
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
November 11, 2020
CompletedFirst Submitted
Initial submission to the registry
July 1, 2022
CompletedFirst Posted
Study publicly available on registry
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2023
CompletedJanuary 22, 2024
January 1, 2024
2.7 years
July 1, 2022
January 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Lactate production
Lactate excretion by monocytes after ex-vivo exposure to inflammatory stimuli
1 day
Cytokine production
Cytokine excretion by monocytes after ex-vivo exposure to inflammatory stimuli. Measured using ELISA for IL-6, IL-1b. IL-1RA, IL-8, TNFalpha.
1 day
Secondary Outcomes (2)
Phagocytosis
1 day
Glycolytic and oxidative capacity
1 day
Other Outcomes (12)
Circulating immune mediators
1 day
Glucose levels
1 day
Lipid profile
1 day
- +9 more other outcomes
Study Arms (2)
Elderly
Young adults
Eligibility Criteria
The study population consists of healthy men and women between the age of 20 - 30 years old and between 60 - 75 years old. The ratio between men and women will be kept equally as much as possible in both groups. The young adults should have a BMI between 18.5 - 25 kg/m2. The elderly subject should have a BMI between 20 - 30 kg/m2. Subjects will be recruited from the surroundings of Wageningen using the mailing list for potential research subjects from the division of Human Nutrition and Health, Wageningen University.
You may qualify if:
- Age 20 - 30y and 60 - 75y
- BMI 18.5 - 25 kg/m2 (young adults); 20 - 30 kg/m2 (elderly)
- Willing to fast overnight for 12 hours
- Willing to give a blood sample
- Having a general practitioner
- Signed informed consent
You may not qualify if:
- Diagnosed with metabolic and/or inflammatory disease (e.g. diabetes, cardiovascular disease (with the exception of hypertension), arthritis, arthrosis, glycogen storage dis-orders and auto-immune diseases)
- Current diagnosis of cancer
- Regular use of medication that interferes with immune function (e.g. corticosteroids, cytokine blockers)
- Regular use of medication that may interfere with metabolism (e.g. metabolic inhibitors or activators)
- Use of medication that interferes with immune function and metabolism in at least one week preceding the study visit (e.g. NSAID, anti-histamines, corticosteroids)
- More than 4kg weight gain or weight loss over the last 4 months
- Vaccination within 3 months preceding the study visit (e.g. immunization against influ-enza, pneumonia, and travel-related infections)
- Donated blood within 2 months preceding the study visit
- Pregnant, lactating or wishing to become pregnant in the period between the screening and study visit (self-reported)
- Regular use of hard drugs and soft drugs (i.e. weekly use) and at least no use within 2 months preceding the study visit
- Excessive alcohol use (i.e. \>14 units per week)
- Use of cigarettes and other tobacco products
- Participation in another study that involves an intervention 2 months preceding the study visit
- Members of the research team
- Working, or doing an internship or thesis at the division "Human Nutrition and Health", Wageningen University
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wageningen Universitylead
- Top Consortium for Knowledge and Innovation (TKI) Argi & Foodcollaborator
- Mead Johnson Nutritioncollaborator
- Hycult Biotechcollaborator
Study Sites (1)
Department of Human Nutrition & Health, Wageningen University
Wageningen, Gelderland, 6708WE, Netherlands
Related Publications (1)
Smeehuijzen L, Vrieling F, Jansen J, van der Zande HJP, Houslay TM, Gross G, van Diepen JA, Afman LA, Stienstra R. Lactate Secretion by Monocytes as a Determinant of Innate Immune Cell Fitness in Healthy Elderly. Aging Cell. 2025 Nov;24(11):e70220. doi: 10.1111/acel.70220. Epub 2025 Oct 13.
PMID: 41078099DERIVED
Biospecimen
Blood samples are used to obtain circulating monocytes
Study Officials
- PRINCIPAL INVESTIGATOR
Lydia Afman
Wageningen University
- PRINCIPAL INVESTIGATOR
Rinke Stienstra
Wageningen University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
July 1, 2022
First Posted
July 11, 2023
Study Start
November 11, 2020
Primary Completion
July 31, 2023
Study Completion
July 31, 2023
Last Updated
January 22, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share
All research subjects will get a numeric code (Pxx-Pxx) that is coupled to their personal data. Personal data will be stored in a closed locker and a password-protected file. Only the investi-gators will have access to the key of the code. The same code will also be used to code the collected material. Subsiding partners do not have access to personal data or material. This will all be done in line with the General Data Protection Regulation (GDPR) effective from the 25th of May 2018 onwards.