Ignite Creation Date:
2024-05-06 @ 1:02 AM
Last Modification Date:
2024-10-26 @ 10:58 AM
Study NCT ID:
NCT01715675
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2012-05-30
Brief Title:
Effects of Plant Stanols on Immune Function in Asthma Patients
Sponsor:
Maastricht University Medical Center
Organization:
Maastricht University Medical Center
Study Overview
Official Title:
The Effect of Plant Stanols on the Immune Function of Asthma Patients
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale Plant stanols are well known for their effects on lowering intestinal cholesterol absorption ultimately resulting in 10-15 reduced serum LDL cholesterol concentrations in humans In addition we have also shown that serum triacylglycerol TG concentrations may be lowered in subjects with elevated baseline concentrations Till now there is little evidence for plant stanol effects other than improving lipid profiles However we have very recently found strong indications in ex vivo models using isolated human peripheral mononuclear blood cells PBMCs from healthy volunteers that plant stanols have the capacity to improve immune function More into detail plant stanols shifted the differentiation of naive T-cells into the Th1 direction by activating a specific receptor present on the Antigen presenting cells APCs and T-cells This effect might ultimately be helpful in situations in which the Th1Th2 cell balance is disturbed into a Th2 over-responsiveness By activating the Th1 response the disturbed balance may be restored This is for example a possibility in the treatment or prevention of asthma food allergies or HIV in susceptible subjects In addition very recently MEC 08-3-051 in a pilot study we also showed these ex vivo Th1 stimulating effects of plant stanols specifically in PBMCs isolated from asthma patients as said a condition characterized by a Th2 dominant immune response
Objective The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients
Study design A double-blind randomized placebo-controlled human intervention study in which 90 patients with clinically proven asthma will participate 45 in the intervention group receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt without added plant stanols At the end of the run-in period as well as at the end of the experimental period blood will be sampled to isolate PBMCs These cells are used to evaluate effects on cytokine production phagocytic capacity of neutrophils and the activity of NK cells In addition the golden standard to show improvements in immune function is by showing an elevated Immunoglobulin response to a vaccine Therefore during the experimental period all subjects receive a vaccination against Hepatitis A Virus After 1 2 3 and 4 weeks blood will be sampled to monitor specific immunoglobulin titers to HAV
Study population 90 people with clinically proven asthma who are not carrier of hepatitis A B or C and have not been vaccinated against hepatitis A in the past Also these participants do not have any other immune-related pathology Main study parametersendpoints primary Specific anti-HAV antibody titers after vaccination secondary Phagocytic capacity of neutrophils NK-cell activity Th1 and Th2 cytokine production profiles by PHA stimulated PMBCs
Nature and extent of the burden and risks associated with participation benefit and group relatedness During the study 9 blood samples each 20 or 50 mL will be taken Total time investment for the subjects will be 160 min Occasionally a heamatoma or bruise can occur during venipuncture After the vaccination a heamatoma or a sore arm can occur These side effects should disappear within 4-5 days Other common side effects related to the vaccination are headache loss of appetite and fatigue which usually will disappear within 24 hours
The results of this study will show whether consumption of plant stanol enriched yogurts is able to restore the disturbed th1Th2 balance in asthma patients Ultimately this is expected to reduce asthmatic exacerbations as the Th2 dominant immune response seems causal to asthmatic symptoms however these clinical improvements are not verified in this relatively short term intervention study
Objective The major research objective is to prove that the consumption of plant stanol ester enriched yogurts can improve immune function in vivo in asthma patients
Study design A double-blind randomized placebo-controlled human intervention study in which 90 patients with clinically proven asthma will participate 45 in the intervention group receiving plant stanol yoghurt and 45 in the control group receiving a control yoghurt without added plant stanols At the end of the run-in period as well as at the end of the experimental period blood will be sampled to isolate PBMCs These cells are used to evaluate effects on cytokine production phagocytic capacity of neutrophils and the activity of NK cells In addition the golden standard to show improvements in immune function is by showing an elevated Immunoglobulin response to a vaccine Therefore during the experimental period all subjects receive a vaccination against Hepatitis A Virus After 1 2 3 and 4 weeks blood will be sampled to monitor specific immunoglobulin titers to HAV
Study population 90 people with clinically proven asthma who are not carrier of hepatitis A B or C and have not been vaccinated against hepatitis A in the past Also these participants do not have any other immune-related pathology Main study parametersendpoints primary Specific anti-HAV antibody titers after vaccination secondary Phagocytic capacity of neutrophils NK-cell activity Th1 and Th2 cytokine production profiles by PHA stimulated PMBCs
Nature and extent of the burden and risks associated with participation benefit and group relatedness During the study 9 blood samples each 20 or 50 mL will be taken Total time investment for the subjects will be 160 min Occasionally a heamatoma or bruise can occur during venipuncture After the vaccination a heamatoma or a sore arm can occur These side effects should disappear within 4-5 days Other common side effects related to the vaccination are headache loss of appetite and fatigue which usually will disappear within 24 hours
The results of this study will show whether consumption of plant stanol enriched yogurts is able to restore the disturbed th1Th2 balance in asthma patients Ultimately this is expected to reduce asthmatic exacerbations as the Th2 dominant immune response seems causal to asthmatic symptoms however these clinical improvements are not verified in this relatively short term intervention study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None