Immune cell activation, cell trafficking, and cytokine changes to pro- and anti-inflammatory cytokines, antiviral peptides, and restorative growth factors Not Applicable
Conditions
Interventions
For this clinical study, human subjects will be tested following an established placebo-controlled, randomized, double-blinded, cross-over study design. Specifically, the study design has been used in
Sponsors
Unigen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults 2. Age 18-75 years (inclusive) 3. BMI between 18.0 and 34.9 kg/m² (inclusive) 4. Veins easy to see in one or both arms (to allow for the multiple blood draws) 5. Willing to comply with study procedures, including: 5.1. Maintaining a consistent diet and lifestyle routine throughout the study 5.2. Consistent habit of bland breakfasts on days of clinic visits 5.3. Abstaining from exercise and nutritional supplements on the morning of a study visit 5.4. Abstaining from use of coffee, tea, and soft drinks for at least 1 hour prior to a clinic visit 5.5. Abstaining from music, candy, gum, computer/cell phone use, during clinic visits
Exclusion criteria
Exclusion criteria: 1. Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder) 2. Taking anti-inflammatory medications on a daily basis 3. Currently experiencing intense stressful events/life changes 4. Currently in intensive athletic training (such as marathon runners) 5. Cancer during the past 12 months 6. Chemotherapy during the past 12 months 7. Currently treated with immune suppressant medication 8. Diagnosed with autoimmune disorders e.g. systemic lupus erythematosus, hemolytic anemia 9. Donation of blood during the study or within the 4 weeks prior to study start 10. Have received a cortisone shot within the past 12 weeks 11. Immunization during last month 12. Currently taking anxiolytic, hypnotic, or anti-depressant prescription medication 13. Ongoing acute infections (including teeth, sinus, ear, etc) 14. Participation in another clinical trial study during this trial, involving an investigational product or lifestyle change 15. An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying) 16. Unwilling to maintain a constant intake of supplements over the duration of the study 17. Anxiety about having blood drawn 18. Women of childbearing potential: pregnant, nursing, or trying to become pregnant 19. Known food allergies related to ingredients in the active test product or placebo 20. Prescription medication will be evaluated on a case-by-case basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immune surveillance, trafficking, and activation of immune cells in vivo, measured using flow cytometry to evaluate immune cell movement in and out of tissue and absolute numbers immune cell populations in the circulating blood. as well as the activity of immune cells showing signs of a higher level of function from blood samples (1 EDTA vial, a total of 6 ml blood) collected at baseline, 1, 2, and 3 h for the first clinic visit (0 days) and at baseline, 1, 2, and 3 h at the second clinic visit (7 days). In order to make these measurements, cells will be stained with a monoclonal antibody towards the CD3/ ?d T Cell Receptor,vii viii and co-stained with CD5. The cells are also stained for CD56 which may be expressed on some ?d T cells.ix The 2 activation markers CD69 and CD25 will also be used. This allows analysis of numbers of the following types of immune cells in the blood circulation at each time point in the study: Add-on panel for numbers of gamma-delta (?d) T cells (?dTCR+ CD5-): 1. CD3/ ?d T Cell Receptor+ CD5- CD56+ 2. CD3/ ?d T Cell Receptor+ CD5- CD56- 3. CD3/ ?d T Cell Receptor+ CD5- CD69+ 4. CD3/ ?d T Cell Receptor+ CD5- CD25+ Cells are stained with the T cell markers CD4 and CD8, the B cell marker CD19, and co-stained with monoclonal antibodies towards CD45Ra and CD45R0 isoforms.vi CD45Ra is expressed on naïve T cells and resting B cells. CD45R0 is expressed on memory T cells and recently activated B cells. Cells expressing both isoforms have recently been through an immune activation event. This allows analysis of numbers of the following types of immune cells in the blood circulation at each time point in the study: 1. CD4 T lymphocytes 2. CD8 T lymphocytes 3. CD19 B lymphocytes Each type of lymphocyte will be analyzed for: 1. CD45RA expression 2. CD45Ra and CD45R0 co-expression 3. CD45R0 expression | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
United States of America
Outcome results
None listed