NCT05940337

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
1 year until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

July 1, 2022

Last Update Submit

January 19, 2024

Conditions

Keywords

ImmunometabolismMonocyteElderlyImmune cell fitness

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

Age20 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

Study Sites (1)

Department of Human Nutrition & Health, Wageningen University

Wageningen, Gelderland, 6708WE, Netherlands

Location

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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples are used to obtain circulating monocytes

Study Officials

  • Lydia Afman

    Wageningen University

    PRINCIPAL INVESTIGATOR
  • Rinke Stienstra

    Wageningen University

    PRINCIPAL INVESTIGATOR

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.

Locations