AgingFTGONCT05940337
FIT to Grow Old - Functionality of the Immune System and Healthy Aging
An observational study of Aging, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Aging
- How many people
- 156 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Nov 2020to 31 Jul 2023
- 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 20 to 75 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Human Nutrition & Health, Wageningen University
Wageningen, Gelderland, 6708WE
About this study
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.
Read the detailed description
Rationale: Aging is commonly associated with reduced functionality of the immune system, resulting in a higher prevalence of infectious disease, auto-immune disease, cancer, and low-er efficiency of vaccination. The reduction in immune functionality is called 'immunosenescence' and is often observed in addition to a chronic state of systemic inflammation, referred to as 'inflammaging'. It is commonly believed that strategies improving immune functionality can be applied to improve healthy aging. Nutritional strategies, in particular, receive increasing attention, as several foods and nutrients are shown to exert immunomodulatory properties. Nutritional strategies focussing on the intake of polyunsaturated fatty acids have indeed shown improvements in cytokine profiles and inflammatory gene expression, but suffer from large inter-individual variation, which might be caused by differences in immune functionality. Recent studies within the field of immunometabolism have 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. To improve the efficiency of immunomodulatory nutritional intervention strategies and work towards personalized approaches to support healthy aging, identifying individuals with reduced immune cell fitness will be crucial.
Objective: The primary aim of this study is to extensively characterize immune cell fitness in the elderly population to distinguish immunologically fit elderly from the unfit. Since immune cell fitness is a new concept, we will define a good immune cell fitness state using a young adult study population. Using a follow-up visit, we will evaluate whether our measure of immune cell fitness is robust and stable over time. Furthermore, to identify potential nutritional strategies to improve immune cell fitness and work towards personalized approaches, we will study the effects of metabolites and nutrients on their ability to improve immune cell fitness in monocytes from the elderly.
Study design: The study will be a cross-sectional study in which we will compare the immune cell fitness state of elderly people using young adult people to define an 'immune fit' status. Immune cell fit-ness will be measured in monocytes, which will be obtained from blood samples. Subjects will be given a standardized meal which they consume in the evening before the study visit at latest 8.00 pm. After consumption of the meal, subjects are not allowed to eat or drink anything but water.
On the study day, before the start of blood sampling, a small blood sample via a finger prick is collected to measure CRP levels. CRP levels of ≥10.0 mg/L indicate severe infection and will consequently exclude the subject from participating on that specific day. The relevant subjects are asked to make a new appointment. If CRP levels are < 10 mg/L, blood sampling will continue.
Blood sampling and anthropometric measurements including body weight, waist and hip circumference and a DEXA scan will be performed in each subject, after which the subjects will receive breakfast. Subjects will fill in an FFQ to gain insights into regular dietary intake. In addition, subjects will fill in questionnaires on sleep quality and general health.
Elderly subjects will be contacted for a follow-up visit at least 6 months and the latest 18 months after the study visit. The study-design of the follow-up visit will be similar to the first study visit, including the standardized meal the evening before, overnight fast, blood sampling, anthropometric measurements (except for the DEXA-scan, this will only be performed as a link between immune cell fitness and fat distribution is found in the first part of the study), and questionnaires. The freshly collected blood sample will be used for our secondary aims, namely 1) to study the effects of nutrients and metabolites on immune cell fitness, and 2) to test whether our measure of immune cell fitness is robust and stable over time.
Update August 2023 Based on our preliminary results, we decided to cancel the follow-up visit.
- Conditions
- Aging
- Keywords
- Immunometabolism, Monocyte, Elderly, Immune cell fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Not described | |
| Young adults | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate production
Lactate excretion by monocytes after ex-vivo exposure to inflammatory stimuli
Measured: 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.
Measured: 1 day
Secondary outcomes (2)
Phagocytosis
Phagocytic capacity of monocytes. Measured using absorbed fluorescent beads and flow cytometry.
Measured: 1 day
Glycolytic and oxidative capacity
Glycolytic and oxidative capacity of monocytes. Measured using Seahorse Assays (Agilent).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start11 Nov 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Cross-sectional
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- TKI Agri & Food, Mead Johnson Nutrition, Hycult Biotech
- Responsible party
- Principal investigator, Lydia A. Afman, Wageningen University
- Investigators
- Lydia Afman, Principal investigator, Wageningen UniversityRinke Stienstra, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940337
- Sponsor's protocol ID
- NL70696.081.19
- Acronym
- FTGO
- Status last verified
- Jan 2024
- First submitted
- 1 Jul 2022
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41078099
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIT to Grow Old - Functionality of the Immune System and Healthy Aging
- ClinicalTrials.gov ID
- NCT05940337
- Acronym / sponsor ID
- FTGO / NL70696.081.19
- Conditions
- Aging
- Keywords
- Immunometabolism, Monocyte, Elderly, Immune cell fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- TKI Agri & Food, Mead Johnson Nutrition, Hycult Biotech
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 11 Jul 2023 (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.
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.
Detailed description
Rationale: Aging is commonly associated with reduced functionality of the immune system, resulting in a higher prevalence of infectious disease, auto-immune disease, cancer, and low-er efficiency of vaccination. The reduction in immune functionality is called 'immunosenescence' and is often observed in addition to a chronic state of systemic inflammation, referred to as 'inflammaging'. It is commonly believed that strategies improving immune functionality can be applied to improve healthy aging. Nutritional strategies, in particular, receive increasing attention, as several foods and nutrients are shown to exert immunomodulatory properties. Nutritional strategies focussing on the intake of polyunsaturated fatty acids have indeed shown improvements in cytokine profiles and inflammatory gene expression, but suffer from large inter-individual variation, which might be caused by differences in immune functionality. Recent studies within the field of immunometabolism have 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. To improve the efficiency of immunomodulatory nutritional intervention strategies and work towards personalized approaches to support healthy aging, identifying individuals with reduced immune cell fitness will be crucial.
Objective: The primary aim of this study is to extensively characterize immune cell fitness in the elderly population to distinguish immunologically fit elderly from the unfit. Since immune cell fitness is a new concept, we will define a good immune cell fitness state using a young adult study population. Using a follow-up visit, we will evaluate whether our measure of immune cell fitness is robust and stable over time. Furthermore, to identify potential nutritional strategies to improve immune cell fitness and work towards personalized approaches, we will study the effects of metabolites and nutrients on their ability to improve immune cell fitness in monocytes from the elderly.
Study design: The study will be a cross-sectional study in which we will compare the immune cell fitness state of elderly people using young adult people to define an 'immune fit' status. Immune cell fit-ness will be measured in monocytes, which will be obtained from blood samples. Subjects will be given a standardized meal which they consume in the evening before the study visit at latest 8.00 pm. After consumption of the meal, subjects are not allowed to eat or drink anything but water.
On the study day, before the start of blood sampling, a small blood sample via a finger prick is collected to measure CRP levels. CRP levels of ≥10.0 mg/L indicate severe infection and will consequently exclude the subject from participating on that specific day. The relevant subjects are asked to make a new appointment. If CRP levels are < 10 mg/L, blood sampling will continue.
Blood sampling and anthropometric measurements including body weight, waist and hip circumference and a DEXA scan will be performed in each subject, after which the subjects will receive breakfast. Subjects will fill in an FFQ to gain insights into regular dietary intake. In addition, subjects will fill in questionnaires on sleep quality and general health.
Elderly subjects will be contacted for a follow-up visit at least 6 months and the latest 18 months after the study visit. The study-design of the follow-up visit will be similar to the first study visit, including the standardized meal the evening before, overnight fast, blood sampling, anthropometric measurements (except for the DEXA-scan, this will only be performed as a link between immune cell fitness and fat distribution is found in the first part of the study), and questionnaires. The freshly collected blood sample will be used for our secondary aims, namely 1) to study the effects of nutrients and metabolites on immune cell fitness, and 2) to test whether our measure of immune cell fitness is robust and stable over time.
Update August 2023 Based on our preliminary results, we decided to cancel the follow-up visit.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | – |
| Young adults | – | – |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
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
Lactate production
Time frame: 1 day
Lactate excretion by monocytes after ex-vivo exposure to inflammatory stimuli
Cytokine production
Time frame: 1 day
Cytokine excretion by monocytes after ex-vivo exposure to inflammatory stimuli. Measured using ELISA for IL-6, IL-1b. IL-1RA, IL-8, TNFalpha.
2 secondary outcomes
Phagocytosis
Time frame: 1 day
Glycolytic and oxidative capacity
Time frame: 1 day
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 22 Jan 2024.
- Derived from this study: PubMed 41078099Smeehuijzen 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.
- Individual participant dataSharing planned: No. 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.
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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.
Lydia Afman principal investigator
Wageningen University
Rinke Stienstra principal investigator
Wageningen University
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 Aging, run by Wageningen University at 1 site in Netherlands.
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 6 inclusion and 15 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 22 Jan 2024. 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 Netherlands. 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?
Lactate production (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05940337, which also lists 1 linked publication.
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 22 Jan 2024.