A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>IFN-a and IL-6 production by PBMCs upon ex vivo TLR7 stimulation. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- TNF-a production by PBMCs upon ex vivo TLR7 stimulation<br /><br>- the percentage IFN-a-, IL-6- or TNF-a-producing pDCs in PBMCs upon ex vivo<br /><br>TLR7 stimulation<br /><br><br /><br>The study will have an additional exploratory character, by analyzing the ex<br /><br>vivo PBMC response to various TLR-stimuli. Also other inflammatory markers and<br /><br>markers of osteoarthritis will be measured in serum/plasma.<br /><br><br /><br>In case of positive outcomes for any of the 3 dietary subsequent intervention<br /><br>periods, fecal samples will be used for analysis of microbiota, SCFAs, and<br /><br>markers of inflammation and gut barrier function (e.g. calprotectin).</p><br>