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CompletedNCT03026244Updated Sep 5, 2018

Effect of Milk Protein and Prebiotics in Combination With Vitamin D on Innate Immunity in Elderly People

An interventional study of Milk protein, prebiotics, vitamin D and Placebo product in Immunosenescence and Inflammation, sponsored by NIZO Food Research. Completed at 1 site in Netherlands. Open to female participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-05.

Sponsored by NIZO Food Research · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
Female
01

Study summary

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 This effect may be mediated via support of the innate immune response and promotes TLR7 signaling in in vitro assays (unpublished observation).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.

02

Conditions studied

  • Immunosenescence
  • Inflammation

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Keywords

  • Immunity
  • Elderly
  • Inflammation
  • Milk protein
  • Prebiotics
03

In context

Inflammation

3,439 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 30 is below the median of 50 across 2,436 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

NIZO Food Research is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Female
  • Age 65-85 years
  • BMI 20-30 kg/m2
  • Non-smoking
  • Generally healthy
  • Regular and normal Dutch eating habits
  • 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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Nutritional intervention product

    Milk protein, prebiotics, vitamin D

    Dietary Supplement: Milk protein, prebiotics, vitamin D

  • Placebo comparator
    Placebo product

    placebo product

    Dietary Supplement: Placebo product

Interventions

  • Dietary supplementMilk protein, prebiotics, vitamin D

    3 weeks supplementation with milk protein only, followed by 3 weeks milk protein + prebiotics, followed by 3 weeks milk protein + prebiotics + vitamin D

  • Dietary supplementPlacebo product

    3 periods of 3 weeks placebo product

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Study locations

1 site
  • NIZO food research
    Ede, 6718 ZB, Netherlands
08

References and documents

Publications

  • van Splunter M, Perdijk O, Fick-Brinkhof H, Feitsma AL, Floris-Vollenbroek EG, Meijer B, Brugman S, Savelkoul HFJ, van Hoffen E, van Neerven RJJ. Bovine Lactoferrin Enhances TLR7-Mediated Responses in Plasmacytoid Dendritic Cells in Elderly Women: Results From a Nutritional Intervention Study With Bovine Lactoferrin, GOS and Vitamin D. Front Immunol. 2018 Nov 20;9:2677. doi: 10.3389/fimmu.2018.02677. eCollection 2018. PubMed 30515164 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03026244
Lead sponsor
NIZO Food Research
Collaborators
FrieslandCampina, Wageningen University
Responsible party
Sponsor
First posted
Jan 20, 2017
Start date
Nov 2016
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Sep 5, 2018

Study contacts

Els van Hoffen, PhD
principal investigator · NIZO Food Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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