Bovine osteopontin (a protein found in the bones and milk of cattle) for elderly immune support
- Conditions
- Vaccination response, immune support in healthy elderlyNot Applicable
- Registration Number
- ISRCTN39995710
- Lead Sponsor
- Arla Foods (Denmark)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 129
1. Age =60 years and healthy
2. Self-reported regular Dutch eating habits as assessed by questionnaire (3 main meals per day)
3. Anti hepatitis B antibody titer = 4 IU/L
4. Non-smokers (ex-smokers can participate)
5. BMI =22 and =30
6. In good health as assessed during screening, and the medical investigator’s professional judgment
7. Adherence to habitual diet, no changes during study period
8. Signed informed consent
9. Ability to follow Dutch verbal and written instructions
10. Willing to accept disclosure of the financial benefit of participation in the study to the authorities concerned
11. Willing to accept use of all encoded data, including publication, and the confidential use and storage of all data for at least 15 years
12. Willing to comply with study procedures, including intake of study products and collection of stool and blood samples
13. Willingness to give up blood donation starting at screening and during the entire study
1. Prior HB vaccination or infection
2. Any vaccination in the past month or any scheduled vaccination during the study period
3. Acute infection in the past month
4. Treatment with oral antibiotics within 2 months of the start of the study,
5. Serious progressive disease or non-stabilized chronic illness (e.g., diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer, chronic kidney or liver disease)
6. History of cancer
7. Gastrointestinal disorders (e.g., inflammatory bowel disease)
8. Immunodeficiency or autoimmune disorder
9. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic corticosteroids, antibodies)
10. Allergy or hypersensitivity to milk proteins, or lactose intolerance
11. Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to pre-study screening
12. Evidence of current excessive alcohol consumption (>4 consumptions/day or >20 consumptions/week) or drug (ab)use
13. Mental status that is incompatible with the proper conduct of the study
14. 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.
15. 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.
16. Personnel of NIZO, EBMR or AFI, their partner and their first- and second-degree relatives.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method