NIS Labs
Klamath Falls, Oregon, 97601, United States
Location status: Recruiting
NCT Number: NCT07127705
The goal for this clinical trial is to compare rapid effects of four products on stem cells, immune activation, and mitochondrial function. A double-blind, placebo-controlled, cross-over study design will be used.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Klamath Falls, Oregon, 97601, United States
Location status: Recruiting
This clinical trial aims at documenting acute effects of consuming four products through evaluation of stem cell surveillance and mitochondrial resilience.
Data on stem cell trafficking will be collected. The testing will show whether consuming the products leads to a rapid change in stem cell surveillance. Data on cellular energy production and mitochondrial resilience in white blood cells under oxidative and inflammatory stress ex vivo will be collected. This testing will show whether consuming the test products leads to support of energy production within mitochondria, under normal and stressed conditions.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 capsules
2 capsules
2 capsules
2 capsules
2 capsules
Time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Changes to the number of stem cells in the blood circulation (number of cells per mL blood).
Data is collected on the following types of stem cells: CD45dimCD34+CD309+, CD45dimCD34+CD309-, CD31++CD34-, CD45-CD90+.
Time frame: Baseline. 1 hour, 2 hours, 3 and hours after ingestion of study drug
Mitochondrial volume per cell under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye MitoTracker is used to obtain relative measures of mitochondrial volume per cell using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.
Time frame: Baseline. 1 hour, 2 hours, and 3 hours after ingestion of study drug
Cellular energy production under unstressed, oxidative stress, and inflammatory stress ex vivo. White blood cells are purified and cultured ex vivo in unstressed versus inflamed culture conditions. The mitochondrial reporter dye JC-1 is a fluorescent cationic dye used to obtain relative measures of mitochondrial membrane potential per cells, using flow cytometry, where the mean fluorescence intensity (MFI) is quantified on lymphocytes, monocytes, and PMN cells.
Contact information is provided by the study sponsor or research team.
Natural Immune Systems Inc
Other
Rapid Response of Stem Cells and Immune Cells for Efficacy: An Acute Randomized Double-blind Placebo-controlled Cross-over Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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