Assess the percentage of responders to hepatitis B vaccination (i.e. attaining anti-hepatitis B antibody titres beyond 10 IU/L) in healthy elderly receiving a daily dose of OPN-10, compared to a placebo product.Secondary objectives:• Compare the…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
immune modulation in healthy subjects
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Anti-hepatitis B antibody titre
Secondary outcome
• Serum cytokines
• Plasma OPN (bOPN and hOPN)
• Plasma LBP
• Symptoms of respiratory infections
• Clinical chemistry and hematology
• Serum P1NP and CTX1
Background summary
Osteopontin (OPN) is a phosphorylated glycoprotein that is present in human
milk and bovine milk. It is involved in immune function. Lacprodan® OPN-10 is a
protein fraction isolated from bovine milk which is rich in OPN. In infants,
supplementation with Lacprodan® OPN-10 is well tolerated, with clinically
proven immunomodulatory outcomes such as downregulation of inflammatory
cytokines and increases in T-cells and monocytes. Potential effects of
Lacprodan® OPN-10 in adults and elderly have not yet been studied. During
aging, the immune system undergoes profound decline, and specifically the
responsiveness of the Th1-response is attenuated. The current study design
therefore aims to investigate the potential immune effects of Lacprodan® OPN-10
in elderly.
Study objective
Assess the percentage of responders to hepatitis B vaccination (i.e. attaining
anti-hepatitis B antibody titres beyond 10 IU/L) in healthy elderly receiving a
daily dose of OPN-10, compared to a placebo product.
Secondary objectives:
• Compare the changes in serum anti-hepatitis B antibody titres between
treatment groups
• Compare the change in circulating cytokines between treatment groups
• Quantify plasma levels of human and bovine OPN at baseline, and after
intervention
• Determine whether intake of OPN-10 affects plasma levels of human OPN.
• Compare the change in serum LPS binding protein (LBP) between treatment groups
• Compare the incidence of infections during the trial, including specific
upper and lower respiratory tract infections, between treatment groups
• Assess the safety of the selected intervention dose, including effects on
markers of bone remodelling
Study design
double-blind, randomized, placebo-controlled trial, with two parallel treatment
arms
Intervention
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 and 3.2 g/day for subjects >=70 kg. The
sachets will be taken twice a day, with a meal.
The placebo treatment consist of sachets in which Lacprodan® OPN-10 is replaced
by maltodextrin. Total duration of the intervention is 14 weeks.
Study burden and risks
The subjects will not benefit directly from participation in this study, apart
from receiving a subject fee for their time investment plus reimbursement of
traveling expenses.
Lacprodan® OPN-10 has a positive novel food evaluation by EFSA and a GRAS
notification, and hence is considered safe
The burden imposed by study procedures includes the daily intake of the study
product, the (7) visits to the research location, the blood sampling (at 6
visits), faecal sample collection (3 times) and the vaccination injection (3
times). The collection of blood samples may produce discomfort or minor
bleeding and the possibility of bruising at the site of the needle puncture.
There is also a slight risk of infection at the site of the needle puncture.
Side effects of hepatitis B vaccination that are reported to occur often or
very often are: loss of appetite, irritability, headache, gastrointestinal
symptoms (e.g., nausea, vomiting, diarrhea, abdominal pain), pain and redness
at the injection site, fatigue, fever, malaise. Less common side effects
include dizziness, myalgia, and influenza-like symptoms.
Overall, the risks associated with participation in this study are considered
small.
Soenderhoej 10-12
Viby J 8260 DK
DK
Soenderhoej 10-12
Viby J 8260 DK
DK
Listed location countries
Age
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 <= 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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81499.028.22 |