Identification of Surrogate Blood and/or Urine Biomarker for Immulina TM in Normal Humans
Overview
- Phase
- Phase 3
- Intervention
- Immulina
- Conditions
- Adherence, Patient
- Sponsor
- University of Mississippi Medical Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- palmitoleic acid, ug/mL
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •pregnant or lactating females
- •significant acute disease
- •recurrent medications for chronic disease
Arms & Interventions
Immulina Dietary Supplementation
Immulina Dietary Supplementation (200 mg per capsule) 4-200 mg capsules given by mouth once on the only study visit day.
Intervention: Immulina
Outcomes
Primary Outcomes
palmitoleic acid, ug/mL
Time Frame: 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
Time Frame: Over 7 hour period
Differences in steric acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
gamma-linolenic acid (GLA), ug/mL
Time Frame: Over 7 hour period
Differences in GLA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
5'-methylsulfinyladenosine (MSA), ug/mL
Time Frame: Over 7 hour period
Differences in MSA between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
linoleic acid, ug/mL
Time Frame: Over 7 hour period
Differences in linoleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
Sulfoquinovose (SQ), ug/mL
Time Frame: Over 7 hour period
Differences in SQ between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
palmitic acid, ug/mL
Time Frame: Over 7 hour period
Differences in palmitic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina
oleic acid, ug/mL
Time Frame: Over 7 hour period
Differences in oleic acid between baseline, 1 hour post-Immulina, 3 hour post-Immulina and 6 hour post-Immulina