Bovine Osteopontin for Elderly Immune Support
- Conditions
- immune modulation in healthy subjectsimmune supportvaccination response
- Registration Number
- NL-OMON53888
- Lead Sponsor
- ARLA Foods Ingredients Group P/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 140
• Age >=60 and healthy
• Self-reported regular Dutch eating habits as assessed by questionnaire (3
main meals per day)
• Anti hepatitis B antibody titer <= 4 IU/L, no prior hepatitis B vaccination or
infection
• Non-smokers
• BMI 22-30
• In good health as assessed during screening, and the medical investigator*s
professional judgment
• Adherence to habitual diet, no changes during study period
• Signed informed consent
• Ability to follow Dutch verbal and written instructions
• Willing to accept disclosure of the financial benefit of participation in the
study to the authorities concerned
• Willing to accept use of all encoded data, including publication, and the
confidential use and storage of all data for at least 15 years
• Willing to comply with study procedures, including intake of study products
and collection of stool and blood samples
• Willingness to give up blood donation starting at run-in and during the
entire study
• Prior HB vaccination or infection
• Any vaccination in the past month or any scheduled vaccination during the
study period
• Acute infection in the past month
• Treatment with oral antibiotics within 2 months of the start of the study,
• Serious progressive disease or non-stabilized chronic illness (e.g., diabetes
mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic
kidney or liver disease)
• History of cancer
• Gastrointestinal disorders (e.g., inflammatory bowel disease)
• Immunodeficiency disorder
• Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic
corticosteroids, antibodies)
• Allergy or hypersensitivity to milk proteins, or lactose intolerance
• Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to
pre-study screening
• Evidence of current excessive alcohol consumption (>4 consumptions/day or >20
consumptions/week) or drug (ab)use
• Mental status that is incompatible with the proper conduct of the study
• Not having a general practitioner, not allowing disclosure of participation
to the general practitioner or not allow to inform the general practitioner
about abnormal results.
• Participation in any clinical trial including blood sampling and/or
administration of substances starting 1 month prior to study start and during
the entire study.
• Personnel of NIZO or ARLA, their partner and their first- and second-degree
relatives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Anti-hepatitis B antibody titre</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Serum cytokines<br /><br>• Plasma OPN (bOPN and hOPN)<br /><br>• Plasma LBP<br /><br>• Symptoms of respiratory infections<br /><br>• Clinical chemistry and hematology<br /><br>• Serum P1NP and CTX1</p><br>