University of Mississippi Medical Center
This is a pilot study for identifying plasma and/or urine-derived adherence/surrogate biomarker candidates for verifying Immulina™ ingestion by human volunteers (collected before and after consumption of Immulina™, a natural dietary supplement).
Adherence, Patient
Immulina
Not Applicable
This pilot study is interventional, and all participants will receive one 800 mg dose of Immulina™ (four 200 mg capsules), a natural supplement, after a baseline blood and urine collection, then follow with 1 hour, 3 hour and 6 hour post-Immulina™ blood and urine collections. Samples will be sent to UM National Center for Natural Products Research (NCNPR) to analyze and compare timed blood and urine samples using gas chromatography and liquid chromatography to detect volatile and non-volatile compounds, gamma-linolenic acid (GLA), sulfoquinovose (SQ), 5'-methylsulfinyladenosine (MSA), palmitic acid, linoleic acid, palmitoleic acid and oleic acid to screen the chemical fingerprints of the human samples. The mean of the 7 biomarkers for the 4 time points will be measured and compared.}}
| Study Type : | Interventional |
| Estimated Enrollment : | 20 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Basic Science |
| Official Title : | Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans |
| Actual Study Start Date : | August 9, 2023 |
| Estimated Primary Completion Date : | October 19, 2023 |
| Estimated Study Completion Date : | October 19, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Immulina Dietary Supplementation Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day. |
Dietary Supplement: Immulina |
| Ages Eligible for Study: | 18 Years to 50 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Clinical Research and Trials Unit - University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216