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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crossover group 1, randomized | Experimental | Crossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is placebo, low dose, high dose. |
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| Crossover group 2, randomized | Experimental | Crossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is low dose, high dose, placebo. |
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| Crossover group 3, randomized | Experimental | Crossover study: Participants consume a test product on each of the three clinic days, at least 1 week apart, allowing for 1 week wash-out period between each product. Participants will consume each of the 2 doses of the active test product versus placebo over 3 weeks. The order of interventions for this group is high dose, placebo, low dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A low dose of seaweed extract | Dietary Supplement | A low dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste. |
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| Measure | Description | Time Frame |
|---|---|---|
| Antioxidant uptake and protection | Changes to antioxidant status of blood samples | 1 and 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Immune cell numbers in blood | 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 | 1 and 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Stem Cell Numbers in Blood | Changes to stem cell surveillance, i.e. the changes in stem cell populations following consumption of the study product: Numbers of CD45dimCD34+CD309+ pluripotential stem cells Numbers of Cd45dim CD34+CD309- progenitor stem cells Numbers of CD45-CD90+ lymphocytes in blood Numbers of CD31++ CD34- endothelial stem cells in blood | 1 and 2 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gitte S. Jensen, PhD | NIS Labs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NIS Labs | Klamath Falls | Oregon | 97601 | United States |
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Placebo-controlled, double-blinded, cross-over study design.
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Participants will not be informed on which intervention they receive on any given day.
| A high dose of seaweed extract | Dietary Supplement | A high dose of the seaweed extract is dissolved in plain rice milk to help camouflage the strong algae-taste. |
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| Placebo | Dietary Supplement | Plain rice milk. |
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| Communication through cytokines. | Serum levels of cytokines, antiviral peptides, and restorative growth factors. | 1 and 2 hours |