Trials / Completed
CompletedNCT05556967
Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM (Trademark) in Normal Humans
Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Mississippi Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
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).
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Immulina | Immulina is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties. |
Timeline
- Start date
- 2023-08-09
- Primary completion
- 2023-10-19
- Completion
- 2023-10-19
- First posted
- 2022-09-27
- Last updated
- 2025-05-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05556967. Inclusion in this directory is not an endorsement.