Immune Surveillance, Stem Cell Surveillance
Conditions
Brief summary
This clinical study aims at documenting rapid effects after consuming single doses of test product, when compared to consuming a placebo. A double-blind, placebo-controlled, cross-over study design will be used.
Detailed description
For each participant, the clinic visits are scheduled at the same time of the day during the morning hours of 7-11 am to control for the effect of circadian fluctuations. One clinic visit involves consuming a placebo and serves as a control for the circadian variations in cytokine levels and immune surveillance for each participant. Since there is interference from exercise and stress with the release versus homing of lymphocytes, the study environment is managed so that any physical and mental stress is minimized during each visit. Upon arrival at a clinic visit, participants complete a questionnaire to help monitor exceptional circumstances that may influence the stress level of that person on that day. Predetermined criteria for re-scheduling a visit include sleep deprivation and acute anxiety. After completing the questionnaire, participants are instructed to remain calm and inactive for 3 hours, comfortably seated in a chair. After the first hour, the baseline blood sample is drawn. Immediately after the baseline sample is drawn, a test product is provided and consumed in the presence of clinic staff. Blood samples are drawn at 1 hour and 2 hours after consumption of the test product or placebo. The blood is tested for antioxidant status, immune cell surveillance, and regenerating properties involving stem cell surveillance. The process of surveillance is the natural process of our immune and stem cells to move through our body and detect problems that need repair. In addition, blood samples are tested for changes to pro- and anti-inflammatory cytokines, antiviral peptides, and restorative growth factors.
Interventions
DIETARY_SUPPLEMENTA low dose of seaweed extract
A low dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.
DIETARY_SUPPLEMENTA high dose of seaweed extract
A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste.
DIETARY_SUPPLEMENTPlacebo
Plain rice milk.
Sponsors
Natural Immune Systems Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants will not be informed on which intervention they receive on any given day.
Intervention model description
Placebo-controlled, double-blinded, cross-over study design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adults; * Age 18-75 years (inclusive); * Veins easy to see in one or both arms (to allow for the multiple blood draws); * Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements; * Willing to comply with study procedures, including: * Maintaining a consistent diet and lifestyle routine throughout the study, * Consistent habit of bland breakfasts on days of clinic visits, * Abstaining from exercising and nutritional supplements on the morning of a study visit, * Abstaining from use of coffee, tea, and soft drinks for at least one hour prior to a clinic visit; * Abstaining from music, candy, gum, computer/cell phone use, during clinic visits.
Exclusion criteria
* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder); * Taking anti-inflammatory medications on a daily basis; * Currently experiencing intense stressful events/life changes; * Currently in intensive athletic training (such as marathon runners); * Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel; * An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying); * Unwilling to maintain a constant intake of supplements over the duration of the study; * Anxiety about having blood drawn; * Women of childbearing potential: Pregnant, nursing, or trying to become pregnant; * Known food allergies related to ingredients in active test product or placebo.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antioxidant uptake and protection | 1 and 2 hours | Changes to antioxidant status of blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immune cell numbers in blood | 1 and 2 hours | Changes to immune cell trafficking and status of immune cell alertness, ie. the changes in immune cell populations and activation following consumption: Numbers of CD3- CD56+ NK cells in blood Numbers of CD3+ CD56+ NKT cells in blood Numbers of CD3+ CD56- T cells in blood Numbers of cells positive for CD25 Numbers of cells positive for CD69 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGitte S. Jensen, PhD
NIS Labs
Outcome results
None listed