Adherence, Patient
Conditions
Keywords
Immulina TM, Healthy Participants, Natural Dietary Supplement
Brief 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.
Interventions
DRUGImmulina
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.
Sponsors
University of Mississippi Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gamma-linolenic acid (GLA), ug/mL | Over 7 hour period | Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| Sulfoquinovose (SQ), ug/mL | Over 7 hour period | Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| 5'-methylsulfinyladenosine (MSA), ug/mL | Over 7 hour period | Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| palmitic acid, ug/mL | Over 7 hour period | Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| linoleic acid, ug/mL | Over 7 hour period | Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| palmitoleic acid, ug/mL | Over 7 hour period | Differences in palmitoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| steric acid, ug/mL | Over 7 hour period | Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
| oleic acid, ug/mL | Over 7 hour period | Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGailen D Marshall, Jr., MD, PhD
University of Mississippi Medical Center
Outcome results
None listed