immune modulation in healthy subjects immune support vaccination response
Conditions
Interventions
The active treatment consists of Lacprodan OPN-10, in the form of sachets, in a
dose of 2.5 g/day for subjects =70 kg. The
sachets will be taken twice a day, with a meal.
The placebo treatment consi
Sponsors
ARLA Foods Ingredients Group P/S
Eligibility
Age
65 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >=60 and healthy • Self-reported regular Dutch eating habits as assessed by questionnaire (3 main meals per day) • Anti hepatitis B antibody titer
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Anti-hepatitis B antibody titre | — |
Secondary
| Measure | Time frame |
|---|---|
| • Serum cytokines • Plasma OPN (bOPN and hOPN) • Plasma LBP • Symptoms of respiratory infections • Clinical chemistry and hematology • Serum P1NP and CTX1 | — |
Countries
Netherlands
Outcome results
None listed