Rationale: The immune system in the ageing population becomes compromised with age (termed "Immunosenescence"). Therefore, elderly people have a decreased ability to respond to infection and vaccination. Furthermore, many of the health issues associated with ageing are linked to inflammation ("Inflammaging"). It has been suggested that this compromised immune function is in part due to reduced Toll-like receptor (TLR) function, which is part of the innate immune system. Milk and dairy based products have been shown to have beneficial effects on inflammation and immunity. This effect may be mediated via support of the innate immune response and promotes TLR7 signaling in in vitro assays (unpublished observation). Also prebiotics have been suggested to influence markers of innate immune function. Furthermore, TLR function has been suggested to be correlated to vitamin D status. Therefore, in the current pilot study, the potential of milk protein, prebiotics and vitamin D to support innate immune function in elderly will be investigated. Objective: Aim of the current study is to evaluate the effect of milk protein on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by prebiotics and Vitamin D will be studied. Study design: The study will be a double-blind placebo-controlled pilot study. Study population: Healthy female elderly subjects of 65-85 years of age. Intervention: Period 1: Milk protein or placebo. Period 2: Milk protein + prebiotics or placebo. Period 3: Milk protein + prebiotics + Vitamin D or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
30
3 weeks supplementation with milk protein only, followed by 3 weeks milk protein + prebiotics, followed by 3 weeks milk protein + prebiotics + vitamin D
3 periods of 3 weeks placebo product
NIZO food research
Ede, Netherlands
Cmax of ex vivo IFN-a production by PBMCs, corrected for baseline
Maximum IFN-a levels after 3, 6 and 9 weeks of treatment as compared to baseline in supernatant of PBMCs ex vivo stimulated with TLR ligands.
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks
Cmax of ex vivo IL-6 production by PBMCs, corrected for baseline
Maximum IL-6 levels after 3, 6 and 9 weeks of treatment as compared to baseline in supernatant of PBMCs ex vivo stimulated with TLR ligands.
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks
Cmax of ex vivo TNF-a production by PBMCs, corrected for baseline
Maximum TNF-a levels after 3, 6 and 9 weeks of treatment as compared to baseline in supernatant of PBMCs ex vivo stimulated with TLR ligands.
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks
Change from baseline in percentage IFN-a producing pDCs
Percentage IFN-a-producing pDCs in PBMCs upon ex vivo stimulation with TLR ligands determined by flow cytometry
Time frame: baseline, and highest percentage at either 3 weeks, 6 weeks, or 9 weeks of treatment
Change from baseline in percentage IL-6 producing pDCs
Percentage IL-6-producing pDCs in PBMCs upon ex vivo stimulation with TLR ligands determined by flow cytometry
Time frame: baseline, and highest percentage at either 3 weeks, 6 weeks, or 9 weeks of treatment
Change from baseline in percentage TNF-a producing pDCs
Percentage TNF-a-producing pDCs in PBMCs upon ex vivo stimulation with TLR ligands determined by flow cytometry
Time frame: baseline, and highest percentage at either 3 weeks, 6 weeks, or 9 weeks of treatment
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