An exploration of the immunomodulatory, anti-inflammatory and antioxidant activities of bovine lactoferrin in healthy males (a pilot study)
- Conditions
- Immune systemInflammatory and Immune System - Normal development and function of the immune system
- Registration Number
- ACTRN12605000289617
- Lead Sponsor
- Blackmores
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 10
Individuals willing to cease all medications over the course of the study, excluding medications for acute conditions such as pain or dyspepsia.
Individual taking antioxidant medications and /or supplements. Individuals with poor venous access. Individuals with auto-immune disorders. Individuals with diabetes. Individuals taking immune suppressant drugsÃ. Individuals taking cytokine or interferon therapy. Individuals taking Echinacea or other immune stimulating herbs. Individuals who smoke cigarettes or any other drug. Individuals with clinically abnormal liver function tests at baseline. Individuals unwilling to have blood taken 7 times during the study. Individuals unwilling to comply with the study protocols. Individuals with any other condition that in the opinion of the researchers could compromise the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In vivo changes in Lymphocyte Subset Counts including Mature T Cells (CD3+), B Cells (CD19+)[Days 1, 8, 10, 15, 17, 22];In vivo changes in Lymphocyte Subset Counts including Helper T cells (CD3+CD4+)[Days 1, 8, 10, 15, 17, 22];In vivo changes in Lymphocyte Subset Counts including Cytotoxic T Cells (CD3+CD8+)[Days 1, 8, 10, 15, 17, 22];In vivo changes in Lymphocyte Subset Counts including Natural Killer Cells (CD3-CD16+and/orCD56+)[Days 1, 8, 10, 15, 17, 22];In vivo changes in Non-Specific Immune Response including Natural Killer cell cytotoxicity[Days 1, 8, 10, 15, 17, 22]
- Secondary Outcome Measures
Name Time Method In vivo changes in Specific Immune Response including: <br>* Activation of T-lymphocytes (CD4 and CD8) <br>* Production of the following six cytokines: <br>* IL-2, TNFá and IFNã predominantly regulating cell-mediated immune response <br>* IL-4, IL-6 and IL-10 predominantly regulating humoral immune response[All measured weekly during the study.];In vivo changes in Serum oxygen radical antioxidant capacity (ORAC).[All measured weekly during the study.]