Dietary Intervention Clinical Trial
Official title:
Double-blind, Placebo Controlled Randomized Parallel Study to Determine the Effects of Pre-pro and Synbiotic Administration on the Immune Response to Influenza Vaccination and Faecal Microbiota in Healthy Adults
The aim of the study is to investigate the effect of dietary supplements such as probiotic, prebiotic and synbiotic on the immune response to influenza vaccination and faecal microbiota in adult healthy volunteers.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | June 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 45 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Signed consent form - Age 40-65 years - Body mass index 18.5-30 inclusive - Good general health as determined by medical questionnaires - Not vaccinated with the current seasonal influenza (2009) or swine flu vaccine Exclusion Criteria: - Evidence of physical or mental disease or planned major surgery, which might limit participation in or completion of the study - History of drug misuse, including alcohol - Allergy to the vaccine - Asplenia and other acquired or congenital immunodeficiency - Severe allergy such as asthma, hay-fever, dermatitis or being treated on these - History of severe abnormal drug reaction - Any autoimmune disease - Diabetic (type 1 or type2) - Food allergy manifested by gastrointestinal, skin, respiratory , neurological, anaphylaxis symptoms - Lactose intolerance showed by clinical symptoms such as nausea, cramping, bloating, diarrhea and flatulence after consuming lactose containing dairy products (milk, yoghurt, butter, cheese, ice-cream, sour cream) or lactose non-dairy products ( whey, milk solids, modified milk ingredients) - Participation in experimental drug trial within four weeks prior to study - Participation in prebiotics or laxative trial within the previous three months - Use of antibiotics within the previous six months - Chronic constipation, diarrhoea or other chronic gastro-intestinal complaint - Intake of other prebiotics or probiotics, drugs active on gastrointestinal motility, or a laxative of any class for four weeks prior to study - Use of prescribed medication - Regular use of aspirin or other anti-inflammatory drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Reading, Food and Nutritional Sciences Department | Reading | Berkshire |
Lead Sponsor | Collaborator |
---|---|
University of Reading |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome would be a higher change in antibody levels in response to influenza vaccination compared to placebo group. | 2 and 4 weeks after vaccination | No | |
Secondary | The secondary outcome would be a change in faecal microbiota groups and a change in their metabolic activities. | at 0, 7 and 10 weeks on pro-, pre,synbiotic treatment | No |
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