Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.
ID
Source
Brief title
Condition
- Other condition
- Immunodeficiency syndromes
- Viral infectious disorders
Synonym
Health condition
ontsteking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IFN-a and IL-6 production by PBMCs upon ex vivo TLR7 stimulation.
Secondary outcome
- TNF-a production by PBMCs upon ex vivo TLR7 stimulation
- the percentage IFN-a-, IL-6- or TNF-a-producing pDCs in PBMCs upon ex vivo
TLR7 stimulation
The study will have an additional exploratory character, by analyzing the ex
vivo PBMC response to various TLR-stimuli. Also other inflammatory markers and
markers of osteoarthritis will be measured in serum/plasma.
In case of positive outcomes for any of the 3 dietary subsequent intervention
periods, fecal samples will be used for analysis of microbiota, SCFAs, and
markers of inflammation and gut barrier function (e.g. calprotectin).
Background summary
The global healthcare system is challenged by tremendous demographic changes
that are occurring worldwide. It is expected that in 2050, 16% of the
population is older than 65 years. Because the risk of health issues increases
with age, it is important to find ways to keep elderly people healthy. With
increasing age, the immune system becomes compromised. Therefore, elderly
people are more sensitive to infections, and vaccinations provide insufficient
protection. Also diseases associated with chronic inflammation occure more
frequently in elderly. It is now generally thought that this is caused by a
decreased ability of the immune system to regulate immune responses
(Immunosenescence).
It is important to identify ways to support the immune system elderly. One way
to achieve this is by food. Lactoferrin is one of the major whey proteins in
milk and has been described to have beneficial effects on the immune system and
to reduce inflammation. In addition to lactoferrin, galacto-oligosaccharides
and vitamin D may also be relevant for support immunity in elderly people.
Study objective
Aim of the current study is to evaluate the effect of lactoferrin on the innate
immune response in elderly in a pilot study. Furthermore, support of this
effect by GOS and Vitamin D will be studied.
Study design
The study will be designed as a parallel double-blind placebo-controlled trial,
in which healthy human elderly subjects (female) will receive 3 weeks
supplementation with LF only, followed by 3 weeks LF + GOS, followed by 3 weeks
LF + GOS + vitamin D. A control group receiving placebo will be included to
check possible confounding of results by time effects. The 9 weeks of
intervention will be preceded by a 2 weeks run-in period with limited dietary
prescriptions.
Blood and fecal samples will be collected before and at 4 time points before,
during and after supplementation. The total study duration is 11 weeks.
Intervention
The intervention group will receive 3 weeks supplementation with LF only,
followed by 3 weeks LF + GOS, followed by 3 weeks LF + GOS + vitamin D. The
placebogroup will receive maltodextrin.
Study burden and risks
The risks of participation in this study are limited. Since the intervention
and placebo products are regular milk ingredients and supplements, which have
been used in infants, adults and elderly subjects, the risks associated with
participation in this study are considered limited.
The main burden of this study consists of the compliance to take a daily dose
of the intervention product, and blood sampling and fecal sample collection at
4 timepoints.
Bronland 20
Wageningen 6708 WH
NL
Bronland 20
Wageningen 6708 WH
NL
Listed location countries
Age
Inclusion criteria
* Female
* Age 65-85 years (if sufficient candidate participants are available, subjects with a higher age (preferentially ><=75 yr) will be included)
* BMI 20-30 kg/m2
* Non-smoking
* Generally healthy as assessed by the NIZO lifestyle and health questionnaire (*Verklaring leefgewoonten en gezondheid*).
* Regular and normal Dutch eating habits as assessed by the NIZO lifestyle and health questionnaire (3 main meals per day)
* Veins suitable for cannulation (blood sampling)
* Voluntary participation
* Having given written informed consent
* Willing to comply with study procedures
* Accept use of all encoded data, including publication, and the confidential use and storage of all data for 15 years.
* Accept disclosure of the financial benefit of participation in the study to the authorities concerned
Exclusion criteria
* Having chronic inflammatory or autoimmune diseases such as rheumatoid arthritis, type 1 diabetes, inflammatory bowel disease
* Disease of GI tract (including major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, known or suspected gastrointestinal disorders, colon or GI tract cancer), liver, gall bladder, kidneys, thyroid gland
* Immune-compromised
* Use of vitamin supplements containing vitamin D and not willing to discontinue this during the study
* Use of anti-inflammatory drugs (for corticosteroids and NSAIDs : frequency >1 per week)
* Use of immunosuppressive drugs
* Excessive alcohol usage (>3 consumptions/day or >15 consumptions/week)
* Participation in any clinical trial including blood sampling and/or administration of substances within 60 days before inclusion in this study
* Use of hormonal replacement therapy
* Mental status that is incompatible with the proper conduct of the study
* A self-reported milk allergy or sensitivity to dairy ingredients
* Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to pre-study screening
* First and second degree relatives of personnel of NIZO food research or Wageningen University, department of Cell Biology and Immunology or Human Nutrition
* Not having a general practitioner
* Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results and eventual adverse events to and from his general practitioner
* Holiday to a sunny country during the study, starting from inclusion
* Light therapy during the study, starting from inclusion
* Use of prebiotic supplements during 2 months before study start, and during the study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57345.081.16 |