Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05940337 |
| Other study ID # |
NL70696.081.19 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 11, 2020 |
| Est. completion date |
July 31, 2023 |
Study information
| Verified date |
January 2024 |
| Source |
Wageningen University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
