Identification of Surrogate Blood And/or Urine Biomarker for Immulina TM (trademark) in Normal Humans
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Study type
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Details and patient eligibility
About
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).
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Males and females, 18-50 years old
- If female of childbearing potential, using acceptable means of birth control or postmenopausal for at least two years
- Healthy
Exclusion criteria
- pregnant or lactating females
- significant acute disease
- recurrent medications for chronic disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Denise Montgomery, MT(ASCP); Donielle N Drakes, MBA
Data sourced from clinicaltrials.gov
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