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

September 3, 2018 updated by: NIZO Food Research

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 This effect may be mediated via support of the innate immune response and promotes TLR7 signaling in in vitro assays (unpublished observation).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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Ede, Netherlands, 6718 ZB
        • NIZO food research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nutritional intervention product
Milk protein, prebiotics, vitamin D
Dietary supplement: Milk 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
Placebo Comparator: Placebo product
placebo product
Dietary supplement: Placebo product
3 periods of 3 weeks placebo product

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 3 weeks, 6 weeks, 9 weeks
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.
baseline, 3 weeks, 6 weeks, 9 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cmax of ex vivo TNF-a production by PBMCs, corrected for baseline
Time Frame: baseline, 3 weeks, 6 weeks, 9 weeks
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.
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
Percentage IFN-a-producing pDCs in PBMCs upon ex vivo stimulation with TLR ligands determined by flow cytometry
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
Percentage IL-6-producing pDCs in PBMCs upon ex vivo stimulation with TLR ligands determined by flow cytometry
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
Percentage TNF-a-producing pDCs in PBMCs upon ex vivo stimulation with TLR ligands determined by flow cytometry
baseline, and highest percentage at either 3 weeks, 6 weeks, or 9 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NIZO Food Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wageningen University
FrieslandCampina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL57345.081.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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