ImmunosenescenceNCT03026244
Effect of Milk Protein and Prebiotics in Combination With Vitamin D on Innate Immunity in Elderly People
A study testing Milk protein, prebiotics, vitamin D in people with Immunosenescence and Inflammation, run by NIZO Food Research at 1 site in Netherlands.
Trial 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"). Read more about this study
- Who is it for?
- Ages 65 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Immunosenescence, Inflammation
- What is being tested?
- Milk protein, prebiotics, vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female
- Age 65-85 years
- BMI 20-30 kg/m2
- Non-smoking
- Generally healthy
- Regular and normal Dutch eating habits
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nutritional Intervention Study to Evaluate the Effect of Milk Protein and Prebiotics in Combination With Vitamin D on Innate Immunity in Elderly People
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.
- Conditions
- Immunosenescence, Inflammation
- Being tested
- Milk protein, prebiotics, vitamin D, Placebo product
- Keywords
- Immunity, Elderly, Inflammation, Milk protein, Prebiotics
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk protein, prebiotics, vitamin DDietary supplement
3 weeks supplementation with milk protein only, followed by 3 weeks milk protein + prebiotics, followed by 3 weeks milk protein + prebiotics + vitamin D
Placebo productDietary supplement
3 periods of 3 weeks placebo product
| Study group | Role | What they receive |
|---|---|---|
| Nutritional intervention product | Active comparator | Milk protein, prebiotics, vitamin D Receives: Dietary Supplement: Milk protein, prebiotics, vitamin D |
| Placebo product | Placebo comparator | placebo product Receives: Dietary Supplement: Placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, 3 weeks, 6 weeks, 9 weeks
Secondary outcomes (4)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, and highest percentage at either 3 weeks, 6 weeks, or 9 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunosenescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- FrieslandCampina, Wageningen University
- Responsible party
- Sponsor
- Investigators
- Els van Hoffen, PhD, Principal investigator, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026244
- Sponsor's protocol ID
- NL57345.081.16
- Status last verified
- Mar 2018
- First submitted
- 12 Jan 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nutritional Intervention Study to Evaluate the Effect of Milk Protein and Prebiotics in Combination With Vitamin D on Innate Immunity in Elderly People
- ClinicalTrials.gov ID
- NCT03026244
- Acronym / sponsor ID
- NL57345.081.16
- Conditions
- Immunosenescence, Inflammation
- Keywords
- Immunity, Elderly, Inflammation, Milk protein, Prebiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- FrieslandCampina, Wageningen University
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nutritional intervention product | Active comparator | Dietary Supplement: Milk protein, prebiotics, vitamin DMilk protein, prebiotics, vitamin D |
| Placebo product | Placebo comparator | Dietary Supplement: Placebo productplacebo product |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Female
- Age 65-85 years
- BMI 20-30 kg/m2
- Non-smoking
- Generally healthy
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milk protein, prebiotics, vitamin D3 weeks supplementation with milk protein only, followed by 3 weeks milk protein + prebiotics, followed by 3 weeks milk protein + prebiotics + vitamin D | Dietary supplement | Nutritional intervention product |
| Placebo product3 periods of 3 weeks placebo product | Dietary supplement | Placebo product |
Primary outcome
Cmax of ex vivo IFN-a production by PBMCs, corrected for baseline
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks
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.
Cmax of ex vivo IL-6 production by PBMCs, corrected for baseline
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks
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.
4 secondary outcomes
Cmax of ex vivo TNF-a production by PBMCs, corrected for baseline
Time frame: baseline, 3 weeks, 6 weeks, 9 weeks
Change from baseline in percentage IFN-a producing pDCs
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
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
Time frame: baseline, and highest percentage at either 3 weeks, 6 weeks, or 9 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Derived from this study: PubMed 30515164van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Els van Hoffen, PhD principal investigator
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk protein, prebiotics, vitamin D in people with Immunosenescence and Inflammation, run by NIZO Food Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of ex vivo IFN-a production by PBMCs, corrected for baseline (time frame: baseline, 3 weeks, 6 weeks, 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03026244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.